Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information.
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance Tool September 2017To request this safety tool, or for more information about this tool, to make a comment, or share a safety issue please contact [email protected]
Error with the barcodes on selected batches of 8 medicinal products Proposed action
Central Alerting System | 04 Sep 2017
Action taken
Status Action due date Date completed
1
Guidance for the Correct Use and Disposal of Batteries Used in Health and Social Care Equipment Proposed action
Central Alerting System | 06 Sep 2017
Action taken
Status Action due date Date completed
1
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Practice audit/search Other (please specify)
Focus Pharmaceuticals has identified an error with the barcodes on the cartons of the listed batches of products. When scanned,
the barcodes may identify the wrong product. The other product details on the carton, including the name, strength and
pharmaceutical form of the medicine are correct.
https://www.gov.uk/drug-device-alerts/error-with-the-barcodes-on-selected-batches-of-8-medicinal-products-by-focus-
pharmaceuticals-distribute-to-pharmacy-and-wholesaler-level
The use and incorrect disposal of batteries may result in equipment/devices emitting smoke and fumes, not functioning
normally, quickly running out of power, being permanently damaged and, in certain circumstances, there may be a fire.
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102843
All Accu-Chek® Insight insulin pumps - risk of alarm failure Proposed action
Central Alerting System | 21 Sep 2017
Action taken
Status Action due date Date completed
1
Miconazole (Daktarin): over-the-counter oral gel contraindicated in patients taking warfarin Proposed action
MHRA Drug Safety Update | 26 Sep 2017
Action taken
Status Action due date Date completed
1
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Manufactured by Roche Diabetes Care – the audible and/or vibration alarms might not function, which may lead to
hyperglycaemia if the user doesn’t see the notification message on the pump.
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102845
Patients taking warfarin should not use over-the-counter miconazole oral gel (Daktarin). If you plan to prescribe miconazole oral
gel in a patient on warfarin, you should closely monitor them and advise that if they experience any sign of bleeding, they should
stop miconazole oral gel and seek immediate medical attention.
https://www.gov.uk/drug-safety-update/miconazole-daktarin-over-the-counter-oral-gel-contraindicated-in-patients-taking-
warfarin
Loperamide (Imodium): reports of serious cardiac adverse reactions with high doses of loperamide associated
with abuse or misuse Proposed action
MHRA Drug Safety Update | 26 Sep 2017
Action taken
Status Action due date Date completed
1
Xarelto 20 mg film-coated tablets - CLASS 2 MEDICINES RECALL Proposed action
Central Alerting System | 28 Sep 2017
Action taken
Status Action due date Date completed
1
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There have been reports of cardiac events including QT prolongation, torsades de pointes, and cardiac arrest in patients who
have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid withdrawal.
https://www.gov.uk/drug-safety-update/loperamide-imodium-reports-of-serious-cardiac-adverse-reactions-with-high-doses-of-
loperamide-associated-with-abuse-or-misuse
Strathclyde Pharmaceuticals Ltd has received a report of a rogue blister strip of 15 mg tablets within
two packs of 20 mg tablets and has decided to recall this batch.
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102848
What is the risk of interaction between opioids and monoamine oxidase inhibitors (MAOIs)? Proposed action
South West Medicines Information and Training | 27th September 2017
Action taken
Status Action due date Date completed
1
Summary of Product Characteristics Updates Proposed action
electronic Medicines Compendium | Sep 2017
Action taken
Status Action due date Date completed
1
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Practice audit/search Other (please specify)
This article considers the risks of interaction between opioids and monoamine oxidase inhibitors.
https://www.sps.nhs.uk/articles/what-is-the-risk-of-interaction-between-opioids-and-monoamine-oxidase-inhibitors-maois/
Aranesp (darbepoetin) – all formulations
Severe cutaneous adverse reactions (frequency not known) including Stevens-Johnson syndrome and toxic epidermal necrolysis,
which can be life-threatening or fatal, have been reported in association with epoetin treatment. Treatment should be
withdrawn immediately.
http://www.medicines.org.uk/emc/medicine/30617
Calcichew (calcium carbonate) 500mg Chewable Tablets
The SPC has been updated to remove aspartame and sorbitol from the list of excipients, and to remove the warning that it
should be avoided by patients with phenylketonuria. Xylitol and sucralose are included as new excipients.
http://www.medicines.org.uk/emc/medicine/28505
Calcichew-D3 Forte Chewable Tablets
Sorbitol and aspartame have been removed from the list of excipients. The warning that Calchichew D3 Forte may be harmful to
people with phenylketonuria has been removed (aspartame is a source of phenylalanine)
http://www.medicines.org.uk/emc/medicine/28502
Decapeptyl SR 22.5mg (triptorelin pamoate)
A number of sections have been updated due to the addition of a new indication for central precocious puberty.
http://www.medicines.org.uk/emc/medicine/24154
Dianette (cyproterone acetate; ethinylestradiol)
Concomitant use with medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir is now contra-indicated as this may
increase the risk of transaminase (ALT) elevations (seen more frequently in women using ethinylestradiol-containing
medications in clinical trials).
http://www.medicines.org.uk/emc/medicine/1814
Decapeptyl SR 22.5mg (triptorelin pamoate)
A number of sections have been updated due to the addition of a new indication for central precocious puberty.
http://www.medicines.org.uk/emc/medicine/24154
Dianette (cyproterone acetate; ethinylestradiol)
Concomitant use with medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir is now contra-indicated as this may
increase the risk of transaminase (ALT) elevations (seen more frequently in women using ethinylestradiol-containing
medications in clinical trials).
http://www.medicines.org.uk/emc/medicine/1814
Dymista (fluticasone propionate/azelastine hydrochloride) nasal spray
Section 4.4 now advises that visual disturbance may be reported with systemic and topical corticosteroid use (symptoms include
blurred vision or other visual disturbances; possible causes include cataract, glaucoma or rare diseases such as central serous
chorioretinopathy.
http://www.medicines.org.uk/emc/medicine/27579
Entocort (budesonide) CR 3mg Capsules
Entocort CR capsules are now licensed for the treatment of active microscopic colitis. The recommended dose is 9 mg once daily
in the morning (corresponding to 3 capsules).
http://www.medicines.org.uk/emc/medicine/172
Epanutin (phenytoin) preparations
Section 4.8 has been updated to include “thyroid function test abnormal” as an adverse drug reaction.
http://www.medicines.org.uk/emc/medicine/13289
Eperzan (albiglutide) 30 mg and 50 mg powder and solvent for solution for injection
Angioedema, as an adverse allergic reaction, is now listed in section 4.8.
http://www.medicines.org.uk/emc/medicine/31399
Epilim (sodium valproate) and Depakote (valproate semisodium) preparations
In patients concomitantly treated with sodium valproate and nimodipine, the exposure to nimodipine can be increased by 50%.
The nimodipine dose should, therefore, be decreased in case of hypotension.
http://www.medicines.org.uk/emc/medicine/25929
EpiPen Adrenaline (Epinephrine) Auto-Injectors
Various changes have been made to the SPC. This includes the addition of the following statement: “rare cases of serious skin
and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene) are known from
post-marketing experience”.
http://www.medicines.org.uk/emc/medicine/26974
Exjade (deferasirox) film-coated tablets
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been added as a rare adverse effect of treatment. If any
severe cutaneous adverse reaction is suspected deferasirox should be discontinued immediately and not reintroduced.
http://www.medicines.org.uk/emc/medicine/32428
EpiPen Adrenaline (Epinephrine) Auto-Injectors
Various changes have been made to the SPC. This includes the addition of the following statement: “rare cases of serious skin
and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene) are known from
post-marketing experience”.
http://www.medicines.org.uk/emc/medicine/26974
Exjade (deferasirox) film-coated tablets
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been added as a rare adverse effect of treatment. If any
severe cutaneous adverse reaction is suspected deferasirox should be discontinued immediately and not reintroduced.
http://www.medicines.org.uk/emc/medicine/32428
Famvir (famciclovir) tablets (all strengths)
The following adverse effects have been added: seizure (frequency not known), anaphylactic shock and anaphylactic reaction
(frequency not known).
http://www.medicines.org.uk/emc/medicine/6651
Faverin (fluvoxamine) 100 mg film-coated tablets
Owing to fluvoxamine being a CYP2C19 inhibitor, the SPC now advises that concomitant use of fluvoxamine and clopidogrel is
discouraged. Clopidogrel is metabolised to its active form by CYP2C19.
http://www.medicines.org.uk/emc/medicine/22124
Fultium-D3 (colecalciferol; cholecalciferol) 3,200IU capsules
SPC has been updated to reflect licence extension for the treatment of vitamin D deficiency in adolescents and also to advise
that Fultium-D3 should not be used in children under the age of 12.
http://www.medicines.org.uk/emc/medicine/28806
Humira (adalimumab) preparations
Various sections of the SPC have been updated to reflect the approval of its use in the treatment of paediatric uveitis.
http://www.medicines.org.uk/emc/medicine/31860
IntronA (interferon alfa-2b) preparations
SPC warns that cases of hepatitis B re-activation have been reported in patients co-infected with hepatitis B and C viruses
treated with interferon, and advises that all patients be screened for hepatitis B before starting treatment. Pericarditis has been
added as a side-effect.
http://www.medicines.org.uk/emc/medicine/20382
Invega (paliperidone) 3 mg, 6mg, 9 mg and 12mg prolonged-release tablets
The recommended initial dose in moderate to severe renal impairment (CrCl 10-50ml/min) is now 3mg every other day
(previously recommended 1.5mg every other day as the initial dose in these patients). The dose may be increased to 3mg once
daily after clinical assessment.
http://www.medicines.org.uk/emc/medicine/30349
Kaletra (100mg lopinavir /25mg ritonavir) film-coated tablets
New contraindications and interaction information with venetoclax, with elbasvir/grazoprevir and with
ombitasvir/paritaprevir/ritonavir with or without dasabuvir have been added to SPC.
http://www.medicines.org.uk/emc/medicine/20855
Invega (paliperidone) 3 mg, 6mg, 9 mg and 12mg prolonged-release tablets
The recommended initial dose in moderate to severe renal impairment (CrCl 10-50ml/min) is now 3mg every other day
(previously recommended 1.5mg every other day as the initial dose in these patients). The dose may be increased to 3mg once
daily after clinical assessment.
http://www.medicines.org.uk/emc/medicine/30349
Kaletra (100mg lopinavir /25mg ritonavir) film-coated tablets
New contraindications and interaction information with venetoclax, with elbasvir/grazoprevir and with
ombitasvir/paritaprevir/ritonavir with or without dasabuvir have been added to SPC.
http://www.medicines.org.uk/emc/medicine/20855
Ketoconazole HRA 200mg Tablets
Drug interactions with edoxaban and isavuconazole have been added. Ketoconazole significantly increased the AUC of
isavuconazole, and concomitant use is not recommended. Dose reductions of edoxaban are recommended with concomitant
use (refer to edoxaban SPC).
http://www.medicines.org.uk/emc/medicine/30077
Mekinist (trametinib) film-coated tablets
Photosensitivity has been added as a common adverse effect of treatment.
http://www.medicines.org.uk/emc/medicine/31241
Mavenclad (cladribine) 10mg tablets: Prescribers guide and patients’ guide
The prescribers guide provides information on the most important risks associated with MAVENCLAD® and monitoring required
to minimise these risks.
http://www.medicines.org.uk/emc/RMM.1034.pdf
Neurontin (gabapentin) preparations
SPC now advises that gabapentin has been associated with severe respiratory depression. Patients with respiratory disease,
renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk and dose adjustments might be
necessary for these patients.
http://www.medicines.org.uk/emc/medicine/27900
Norvir (ritonavir) products
Contraindication regarding the interaction between ritonavir and venetoclax has been added to SPC.
http://www.medicines.org.uk/emc/medicine/22952
Orkambi (lumacaftor and ivacaftor) 200 mg/125 mg film-coated tablets
SPC has been updated to note serious respiratory events were seen more frequently in patients with percent predicted FEV1
<40, to describe the risk of potential fatal decompensation in patients with cirrhosis and portal hypertension, and to add
cataracts as a side-effect.
http://www.medicines.org.uk/emc/medicine/31534
Prolia (denosumab)
Cataracts as an adverse drug reaction of denosumab has been removed from the SPC.
http://www.medicines.org.uk/emc/medicine/23127
Orkambi (lumacaftor and ivacaftor) 200 mg/125 mg film-coated tablets
SPC has been updated to note serious respiratory events were seen more frequently in patients with percent predicted FEV1
<40, to describe the risk of potential fatal decompensation in patients with cirrhosis and portal hypertension, and to add
cataracts as a side-effect.
http://www.medicines.org.uk/emc/medicine/31534
Prolia (denosumab)
Cataracts as an adverse drug reaction of denosumab has been removed from the SPC.
http://www.medicines.org.uk/emc/medicine/23127
Proscar (finasteride) 5mg film-coated Tablets
SPC now warns that cases of depression, mood alterations and suicidal ideation have been reported.
http://www.medicines.org.uk/emc/medicine/1190
Reyataz (atazanavir) Capsules
Sections 4.4 and 4.8 have been updated with post-marketing reports of chronic kidney disease (frequency uncommon). Regular
monitoring of renal function is advised throughout the treatment duration.
http://www.medicines.org.uk/emc/medicine/14145
Siklos (hydroxycarbamide) 1000mg Film-Coated Tablets
Educational materials for physicians contain important information on minimising the risk of serious adverse events and
monitoring requirements. A booklet for patients contains safety information that they need to be aware of before, during and
after treatment with Siklos.
http://www.medicines.org.uk/emc/medicine/26268#rmm
Sovaldi (sofosbuvir) 400 mg film-coated tablets
SPC has been updated with an extension of indication to include treatment of chronic hepatitis C in adolescents aged 12 to < 18
years.
http://www.medicines.org.uk/emc/medicine/28539
Stivarga (regorafenib) 40 mg film-coated tablets
Regorafenib is now licensed for the treatment of adults with hepatocellular carcinoma who have been previously treated with
sorafenib. Changes relating to this new indication have been made throughout the SPC.
http://www.medicines.org.uk/emc/medicine/28270
Tafinlar (dabrafenib) 50 mg & 75 mg hard capsules
Data from an interaction study with rabeprazole has been added; the SPC now notes that medicines that alter the pH of the
upper gastrointestinal tract are not expected to reduce the bioavailability of dabrafenib. Data from an interaction study with
rifampin has also been added.
http://www.medicines.org.uk/emc/medicine/28432
Tobradex (tobramycin and dexamethasone) Eye Drops
Additions include anaphylactic reaction and erythema multiforme (adverse effects); untreated parasitic eye infections
(contraindication); and a paragraph on interaction with inhibitors of CYP3A4. Sections on pregnancy and breastfeeding have
been completely updated.
http://www.medicines.org.uk/emc/medicine/4670
Tafinlar (dabrafenib) 50 mg & 75 mg hard capsules
Data from an interaction study with rabeprazole has been added; the SPC now notes that medicines that alter the pH of the
upper gastrointestinal tract are not expected to reduce the bioavailability of dabrafenib. Data from an interaction study with
rifampin has also been added.
http://www.medicines.org.uk/emc/medicine/28432
Tobradex (tobramycin and dexamethasone) Eye Drops
Additions include anaphylactic reaction and erythema multiforme (adverse effects); untreated parasitic eye infections
(contraindication); and a paragraph on interaction with inhibitors of CYP3A4. Sections on pregnancy and breastfeeding have
been completely updated.
http://www.medicines.org.uk/emc/medicine/4670
Topamax (topiramate) all strengths
Section 4.4 now advises the risk for hyperammonemia with topiramate appears dose-related and has been reported more
frequently when topiramate is used concomitantly with valproic acid and provides advice on management. Sections 4.5 and 4.8
have also been updated accordingly.
http://www.medicines.org.uk/emc/medicine/31483
Vargatef (nintedanib) 100 mg and 150 mg soft capsules
Information regarding post-marketing cases of diarrhoea (serious) and bleeding (serious and non-serious) has been added, as
has information regarding the possible requirement for interruption, dose reduction and discontinuation of therapy in an event
of dehydration.
http://www.medicines.org.uk/emc/medicine/29790
Varilrix (live attenuated varicella-zoster virus - Oka strain) vaccine
Varilrix is now licensed for active immunisation against varicella of healthy subjects from the age of 9 months. Other sections
have been revised to reflect this indication. Additionally, information about interchangeability with other varicella-containing
vaccines has been added
http://www.medicines.org.uk/emc/medicine/9787
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance Tool August 2017To request this safety tool, or for more information about this tool, to make a comment, or share a safety issue please contact [email protected]
Prescribing regular drugs to prevent febrile convulsions risks more harm than benefit Proposed action
National Institute for Health Research | 01-August-2017
Action taken
Status 1
Date completed
Shortage of Adult Hepatitis B Vaccine Proposed action
Central Alerting System | 07-August-2017
Action taken
Status 1
Date completed
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Practice audit/search OtherExpert commentary is provided for a systematic review which found that intermittent diazepam, but not other
treatments, reduced the risk of recurrent febrile convulsions. Prophylactic treatment can have adverse effects,
and although scary, recurrent febrile convulsions are benign.
https://discover.dc.nihr.ac.uk/portal/article/4000735/prescribing-regular-drugs-to-prevent-febrile-
convulsions-risks-more-harm-than-benefit
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherThere is a global shortage of hepatitis B vaccine which is currently impacting severely on the UK supply. The
situation is particularly critical during August but there is likely to still be some limitations on supply until early
2018. PHE have developed temporary recommendations to support clinicians undertaking an individual risk
assessment to ensure that stock is available for those individuals at highest and most immediate risk of
exposure to hepatitis B.
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102818
Adrenaline auto-injectors: updated advice after European review Proposed action
Medicines and Healthcare products Regulatory Agency | 15-August 2017
Action taken
Status 1
Date completed
Corticosteroids: rare risk of central serous chorioretinopathy with local as well as systemic
administration Proposed action
Medicines and Healthcare products Regulatory Agency | 15-August 2017
Action taken
Status 1
Date completed
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Practice audit/search OtherIt is recommended that 2 adrenaline auto-injectors are prescribed, which patients should carry at all times.
https://www.gov.uk/drug-safety-update/adrenaline-auto-injectors-updated-advice-after-european-review
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherCentral serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of
corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and
intranasal, epidural, intra-articular, topical dermal, and periocular routes.
https://www.gov.uk/drug-safety-update/corticosteroids-rare-risk-of-central-serous-chorioretinopathy-with-
local-as-well-as-systemic-administration
Insulin pens: NovoPen Echo and NovoPen 5 (certain batches) - risk of hyperglycaemia due to
cartridge holder weakening when exposed to certain household chemicals Proposed action
Medicines and Healthcare products Regulatory Agency | 24-August 2017
Action taken
Status 1
Date completed
Differentiation of Mirena, Jaydess and Kyleena levonorgestrel intrauterine delivery systems Proposed action
Bayer | 03-August-2017
Action taken
Status 1
Date completed
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Practice audit/search OtherManufactured by Novo Nordisk - recall and replacement of specific batches of cartridge holder
https://www.gov.uk/drug-device-alerts/insulin-pens-novopen-echo-and-novopen-5-certain-batches-risk-of-
hyperglycaemia-due-to-cartridge-holder-weakening-when-exposed-to-certain-household-chemicals
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherKyleena is a newly licensed levonorgestrel intrauterine delivery system (IUS), providing contraception for up to
five years. This education pack highlights the differences between this and the other two Bayer IUS currently
available in the UK (Jaydess and Mirena).
http://www.medicines.org.uk/emc/RMM.1018.pdf
Summary of Product Characteristics Update Proposed action
electronic Medicines Compendium | August 2017
Action taken
Status 1
Date completed
lOptimise Rx/ScriptSwitchNewsletter
Practice audit/search Other
Aidulan (ethinylestradiol 20microg/ gestodene 75microg) film-coated tablets
SPC has been updated with contraindication for concomitant use with ombitasvir/paritaprevir/ritonavir and
dasabuvir as ALT elevations higher than 5 times upper limit of normal have been reported in women using
ethinylestradiol-containing medication with these drugs.
http://www.medicines.org.uk/emc/medicine/31258
Arava (leflunomide) 100mg Tablets
SPC now warns measurement of ionised calcium levels might show falsely decreased values with leflunomide
and/or teriflunomide depending on type of ionised calcium analyser used. In case of doubtful measurements,
total albumin adjusted serum calcium should be measured.
http://www.medicines.org.uk/emc/medicine/26343
Arava (leflulnomide) tablets
Measurement of ionised calcium levels might show falsely decreased values in patients on leflunomide. In case
of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium
concentration.
http://www.medicines.org.uk/emc/medicine/26344
Calcichew Forte (calcium carbonate) Chewable Tablets
The tablets no longer contain aspartame (E951) or sorbitol (E420). The warning about the use of this product in
patients with phenylketonuria has been removed.
http://www.medicines.org.uk/emc/medicine/28503
Cosopt Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container
The shelf life has been increased to 30 months and the product should not be stored above 25’C.
http://www.medicines.org.uk/emc/medicine/31335
Cubicin (daptomycin) powder for concentrate for solution for injection or infusion
The SPC now notes that the adverse effect eosinophilic pneumonia occasionally presents as organising
pneumonia [defined pathologically by the presence in the distal air spaces of buds of granulation tissue]
(frequency unknown).
http://www.medicines.org.uk/emc/medicine/17341
Cuvitru (Human normal immunoglobulin) solution for subcutaneous injection
The manufacturers now highlight that that if the preparation remains in siliconized syringes for more than two
hours, visible particles may form. It states that the infusion must be started immediately upon transfer into the
syringe to prevent particulate formation.
http://www.medicines.org.uk/emc/medicine/33220
Cuvitru (Human normal immunoglobulin) solution for subcutaneous injection
The manufacturers now highlight that that if the preparation remains in siliconized syringes for more than two
hours, visible particles may form. It states that the infusion must be started immediately upon transfer into the
syringe to prevent particulate formation.
http://www.medicines.org.uk/emc/medicine/33220
Daktarin (miconazole) Sugar Free 2% Oral Gel
The SPC now details the interaction with warfarin, and the product packaging has been updated to state that
patients should not use if they are taking warfarin. Concomitant use can substantially increase INR, and fatal
outcomes (due to bleeding) have been reported.
http://www.medicines.org.uk/emc/medicine/22032
Darzalex (daratumumab) 20 mg/mL concentrate for solution for infusion
Section 6.3 now advises that the unopened vials have a shelf life of 24 months (previously 18 months).
http://www.medicines.org.uk/emc/medicine/32088
Eumovate Ointment (0.05% w/w clobetasone butyrate)
Sections 4.4 and 4.8 have been updated to align to the PRAC recommendation with regard to blurred vision
and central serous chorioretinopathy. Section 4.4 also now contains a statement relating to fire hazard in
contact with dressings, clothing and bedding.
http://www.medicines.org.uk/emc/medicine/2607
Epanutin (phenytoin) Ready Mixed Parenteral
Sections 4.4 and 4.8 now include warnings about cardiovascular adverse effects, with asystole/cardiac arrest
and bradycardia listed as possible adverse effects.
http://www.medicines.org.uk/emc/medicine/14232
Giotrif (afatinib) 20 mg/30 mg/40 mg/50 mg film-coated tablets
Nail disorder has been added to SPC as adverse effect of common frequency.
http://www.medicines.org.uk/emc/medicine/28353
Harvoni 90 mg/400 mg (ledipasvir and sofosbuvir) film-coated tablets
The indication has been extended to include treatment of chronic hepatitis C in adolescents aged 12 to < 18
years. Various other sections of the SPC have also been updated as a consequence.
http://www.medicines.org.uk/emc/medicine/29471
Januvia (sitagliptin) and Janumet (sitagliptin/metformin) tablets
SPC now highlights that there have been post-marketing reports of bullous pemphigoid in patients taking DPP-
4 inhibitors including sitagliptin. If bullous pemphigoid is suspected, sitagliptin treatment should be
discontinued.
http://www.medicines.org.uk/emc/medicine/19609
Harvoni 90 mg/400 mg (ledipasvir and sofosbuvir) film-coated tablets
The indication has been extended to include treatment of chronic hepatitis C in adolescents aged 12 to < 18
years. Various other sections of the SPC have also been updated as a consequence.
http://www.medicines.org.uk/emc/medicine/29471
Januvia (sitagliptin) and Janumet (sitagliptin/metformin) tablets
SPC now highlights that there have been post-marketing reports of bullous pemphigoid in patients taking DPP-
4 inhibitors including sitagliptin. If bullous pemphigoid is suspected, sitagliptin treatment should be
discontinued.
http://www.medicines.org.uk/emc/medicine/19609
Keytruda (pembrolizumab) solution for infusion
Sections 4.2, 4.4 and 4.8 have been updated with information on immune-related skin adverse reactions
including cases of Stevens-Johnson syndrome and toxic epidermal necrolysis, some with fatal outcome.
Depending on severity, treatment should be withheld or discontinued.
http://www.medicines.org.uk/emc/medicine/33162
Loceryl Curanail (amorolfine) 5% w/v Medicated Nail Lacquer
Following post-marketing experience, systemic hypersensitivity has been added as a potential adverse effect
of treatment (frequency unknown).
http://www.medicines.org.uk/emc/medicine/17637
Loceryl (amorolfine) Nail Lacquer 5%
SPC now highlights that after application, an interval of at least 10 min should be respected before application
of any cosmetic nail lacquer. Before repeat application, the cosmetic nail lacquer should be removed carefully.
http://www.medicines.org.uk/emc/medicine/6408
Lynparza (olaparib) 50 mg hard capsules
Rash, hypersensitivity and dermatitis have been added to SPC as adverse events.
http://www.medicines.org.uk/emc/medicine/30359
Maxitrol (dexamethasone, polymyxin and neomycin) Ointment
SPC has been updated to warn that Cushing's syndrome and/or adrenal suppression linked to systemic
absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy. Also visual
disturbance may be reported with systemic and topical corticosteroid use.
http://www.medicines.org.uk/emc/medicine/70
Moviprep, powder for oral solution
The details on the procedure for use is now separated into different sections for procedures under general
anaesthesia and procedures without general anaesthesia.
http://www.medicines.org.uk/emc/medicine/19285
Maxitrol (dexamethasone, polymyxin and neomycin) Ointment
SPC has been updated to warn that Cushing's syndrome and/or adrenal suppression linked to systemic
absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy. Also visual
disturbance may be reported with systemic and topical corticosteroid use.
http://www.medicines.org.uk/emc/medicine/70
Moviprep, powder for oral solution
The details on the procedure for use is now separated into different sections for procedures under general
anaesthesia and procedures without general anaesthesia.
http://www.medicines.org.uk/emc/medicine/19285
Munalea 150/30 (desogestrel/ethinylestradiol) micrograms Film-coated Tablets
Sections 4.3, 4.4 and 4.5 warns that Munalea should not be used by patients with hepatitis C taking
ombitasvir/paritaprevir/ritonavir and dasabuvir. Concomitant use may increase the risk of ALT elevations; an
alternative method of contraception must be considered.
http://www.medicines.org.uk/emc/medicine/31009
Olumiant (baricitinib) 2 mg and 4 mg Film-Coated Tablets
Section 4.4 now warns that events of DVT and PE have been reported in patients receiving baricitinib. It should
be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of
DVT/PE, or patients undergoing surgery and immobilisation
http://www.medicines.org.uk/emc/medicine/32997
ORENCIA (abatacept) 250 mg powder for concentrate for solution for infusion
Abatacept is now licensed, alone or with methotrexate (MTX), for the treatment of active psoriatic arthritis in
adults when the response to previous DMARD, including MTX has been inadequate, and for whom additional
systemic therapy for psoriatic skin lesions is not required.
http://www.medicines.org.uk/emc/medicine/19714
Oruvail (ketoprofen) 100mg capsules
Section 4.5 has been updated to include interactions with: heparin, vit K antagonists (e.g. warfarin), platelet
aggregation inhibitors (e.g. ticlopidine, clopidogrel), thrombin inhibitors (e.g. dabigatran) and direct factor Xa
inhibitors (e.g. apixaban, rivaroxaban, edoxaban).
http://www.medicines.org.uk/emc/medicine/25505
Otomize (neomycin/ dexamethasone)
SPC has been updated to warn visual disturbance may be reported with systemic/topical corticosteroid use.
Patients with these ADRs should be considered for referral to ophthalmologist as causes may include cataract,
glaucoma or rare diseases e.g. central serous chorioretinopathy.
http://www.medicines.org.uk/emc/medicine/13699
Perjeta (pertuzumab) 420 mg Concentrate for Solution for Infusion
Section 4.2 now advises that the infusion should be discontinued immediately and permanently if the patient
experiences a NCI-CTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress
syndrome.
http://www.medicines.org.uk/emc/medicine/27473
Otomize (neomycin/ dexamethasone)
SPC has been updated to warn visual disturbance may be reported with systemic/topical corticosteroid use.
Patients with these ADRs should be considered for referral to ophthalmologist as causes may include cataract,
glaucoma or rare diseases e.g. central serous chorioretinopathy.
http://www.medicines.org.uk/emc/medicine/13699
Perjeta (pertuzumab) 420 mg Concentrate for Solution for Infusion
Section 4.2 now advises that the infusion should be discontinued immediately and permanently if the patient
experiences a NCI-CTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress
syndrome.
http://www.medicines.org.uk/emc/medicine/27473
Praxbind (idarucizumab) 2.5 g/50 mL solution for injection/infusion
Sections 6.3 (Shelf life) and 6.4 (Special precautions for storage) of the SPC have been updated to reflect room
temperature now defined as 30 degrees (previously 25 degrees).
http://www.medicines.org.uk/emc/medicine/31243
Qvar (beclomethasone) inhalers (all products)
SPCs revised to warn of possible systemic effects with concomitant use of strong CYP3A inhibitors (e.g.
ritonavir, cobicistat). Appropriate monitoring is advised with use of such agents, though beclomethasone is
less dependent on CYP3A metabolism than other steroids
http://www.medicines.org.uk/emc/medicine/23274
Seebri (glycopyrronium) Breezhaler Inhalation Powder
Nausea, vomiting (both uncommon) and musculoskeletal pain (common) have been added as potential
adverse reactions to treatment.
http://www.medicines.org.uk/emc/medicine/27138
Sirturo (bedaquiline fumarate) 100 mg tablets
Section 4.4 now advises that when bedaquiline is co administered with other medicinal products that prolong
QTc interval (including delamanid and levofloxacin), an additive or synergistic effect on QT prolongation
cannot be excluded. Caution is recommended.
http://www.medicines.org.uk/emc/medicine/29644
Soliris (eculizumab)
The indication has been updated to include treatment of adults with refractory generalized myasthenia gravis
who are anti-acetylcholine receptor antibody-positive (information relating to this new indication has been
added to various sections of the SPC).
http://www.medicines.org.uk/emc/medicine/19966
Temomedac (temozolomide) 140mg hard capsules
Following PRAC Recommendation, SPC has been updated with warning that post marketing cases of
meningoencephalitis herpetic (including fatalities) has been observed in patients on temozolomide in
combination with radiotherapy, including cases on concomitant steroids.
http://www.medicines.org.uk/emc/medicine/23338
Soliris (eculizumab)
The indication has been updated to include treatment of adults with refractory generalized myasthenia gravis
who are anti-acetylcholine receptor antibody-positive (information relating to this new indication has been
added to various sections of the SPC).
http://www.medicines.org.uk/emc/medicine/19966
Temomedac (temozolomide) 140mg hard capsules
Following PRAC Recommendation, SPC has been updated with warning that post marketing cases of
meningoencephalitis herpetic (including fatalities) has been observed in patients on temozolomide in
combination with radiotherapy, including cases on concomitant steroids.
http://www.medicines.org.uk/emc/medicine/23338
Temomedac (temozolomide) 250mg hard capsules
Sections 4.4 and 4.8 note that post marketing cases of herpetic meningoencephalitis (including fatal cases)
have been reported (frequency uncommon) in patients receiving temozolomide in combination with
radiotherapy, including cases of concomitant steroid administration.
http://www.medicines.org.uk/emc/medicine/23336
TicoVac (tick-borne encephalitis vaccine) Junior 0.25 ml Suspension for injection in a pre-filled syringe
Guillain-Barré syndrome has been added to SPC as rare adverse effect.
http://www.medicines.org.uk/emc/medicine/30334
Toctino (alitretinoin) 10mg and 30mg soft capsules
Section 4.8 now lists photosensitivity reactions and nail disorders as new post marketing adverse reactions.
http://www.medicines.org.uk/emc/medicine/21177
Tyverb (lapatinib)
Stevens-Johnson syndrome and toxic epidermal necrolysis have been added to SPC as adverse effects of
unknown frequency.
http://www.medicines.org.uk/emc/medicine/20929
Xalkori (crizotinib) 200mg and 250mg hard capsule
Section 4.1 now clarifies that crizotinib is to be used as monotherapy only, for anaplastic lymphoma kinase
(ALK)-positive advanced non-small cell lung cancer.
http://www.medicines.org.uk/emc/medicine/27168
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance Tool July 2017To request this safety tool, or for more information about this tool, to make a comment, or share a safety issue please contact [email protected]
Risk of death and severe harm from ingestion of superabsorbent polymer gel granules Proposed action
Central Alerting System | 05-July-2017
Action taken
Status 1
Date completed
Important safety information for people with diabetes using NovoPen® Echo® or
NovoPen® 5 Proposed action
Novo Nordisk | 05-July-2017
Action taken
Status 1
Date completed
Clexane (enoxaparin sodium) Proposed action
Sanofi |June-2017
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Practice audit/search Other
Superabsorbent polymer gel granules are widely used in health and social care, typically as small sachets
placed in urine and vomit bowls. If the gel granules are put in the mouth they expand on contact with saliva
risking airway obstruction. This has happened where patients have mistaken the sachets for sweets, or sugar
or salt packets, but some incident reports also describe attempts of deliberate self-harm. Healthcare providers
are asked to review their overall approach to using these products.
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102798
The insulin cartridge holder used in some batches of NovoPen Echo and NovoPen 5 may crack or break if
exposed to certain chemicals (e.g. household cleaning agents). Patients should check their device and contact
the manufacturer for replacement if it belongs to an affected batch.
http://offlinehbpl.hbpl.co.uk/NewsAttachments/2MM/170705-Important-safety-information-for-people-with-
diabetes-using-NovoPen-Echo-or-NovoPen-5.pdf
Updates to strength expression, dose regimens in DVT/PE, use in patients with severe renal impairment
https://assets.publishing.service.gov.uk/media/596f669a40f0b60a400001ba/Clexane_DHPC_300617.pdf
Action taken
Status 1
Date completed
The safer management of controlled drugs Proposed action
Care Quality Commission | 27-July-2017
Action taken
Status 1
Date completed
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Updates to strength expression, dose regimens in DVT/PE, use in patients with severe renal impairment
https://assets.publishing.service.gov.uk/media/596f669a40f0b60a400001ba/Clexane_DHPC_300617.pdf
Prescribers must make sure that they review patients regularly, depending on their clinical need. This is to
ensure that the prescribed controlled drugs and length of treatment continues to be the most appropriate for
their condition and to reduce opportunities for over prescribing and diversion.
http://www.cqc.org.uk/sites/default/files/20170718_controlleddrugs2016_report.pdf
Epilim (sodium valproate) risk management material Proposed action
Sanofi UK | July-2017
Action taken
Status 1
Date completed
Glucose content of Lucozade Energy drinks reduced by 50% from April 2017 Proposed action
Royal Pharmaceutical Society of Great Britain | 30-March-2017
Action taken
Status 1
Date completed
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This poster, to be displayed in dispensaries of pharmacies warns that valproate should only be used in girls,
women of child bearing age and those who are pregnant or planning pregnancy, when other treatments are
ineffective or not tolerated. http://www.medicines.org.uk/emc/RMM.1002.pdf
Sanofi has issued letters for specialists and specialist nurses/midwives, GPs and pharmacists advising that
valproate medicines should be used only when no other treatment is effective or tolerated in girls, women of
childbearing age, and women who are pregnant/planning pregnancy.
http://www.medicines.org.uk/emc/medicine/23020#rmm
People with diabetes who consume Lucozade Energy Original for the treatment of hypoglycaemia should be
advised to check the label of any product purchased to ensure that they are aware of the correct quantity to
consume.
http://www.medicinesresources.nhs.uk/en/Medicines-Awareness/Safety-Alerts/Safety-alerts/Glucose-
content-of-Lucozade-Energy-drinks-to-be-reduced-by-50-from-April-2017/
Summary of Product Characteristics Update Proposed action
July-2017
Action taken
Status 1
Date completed
lOptimise Rx/ScriptSwitchNewsletter
Practice audit/search Other
Alecensa (alectinib) 150 mg Hard Capsules
SPC updated with information about reports of increased alkaline phosphatase in the post-marketing period.
Cases were also reported in pivotal Phase II clinical trials NP28761 and NP28673. This has been added to SPC
as a common adverse effect.
http://www.medicines.org.uk/emc/medicine/33005
Alprolix (eftrenonacog alfa) powder and solvent for solution for injection
The SPC now states that some patients who are well-controlled on a once every 10 days regimen might be
treated on an interval of 14 days or longer. Side-effects of FIX inhibitor development and hypersensitivity
(observed in post-marketing experience) have been added.
http://www.medicines.org.uk/emc/medicine/32153
Anoro Ellipta (55 micrograms umeclidinium /22 micrograms vilanterol) inhalation powder, pre-dispensed
Dysphonia (voice disorder) has been added to SPC as adverse reaction of uncommon frequency.
http://www.medicines.org.uk/emc/medicine/28949
Atriance (nelarabine) 5 mg/ml solution for infusion
SPC updated to warn that patients treated with nelarabine are potentially at risk of suffering from somnolence
during and for several days after treatment therefore they should be warned that somnolence can affect
performance of skilled tasks, such as driving.
http://www.medicines.org.uk/emc/medicine/20045
Aubagio (teriflunomide) 14 mg film-coated tablets
SPC now warns measurement of ionised calcium (IC) levels might show falsely decreased values under
treatment with leflunomide and/or teriflunomide (metabolite) depending on type of IC analyser used. In case
of doubt, total albumin adjusted serum calcium level should be measured.
http://www.medicines.org.uk/emc/medicine/28533
Bexsero Meningococcal Group B vaccine for injection in pre-filled syringe
The SPC now notes that reported injection site reactions include extensive swelling of the vaccinated limb and
injection site nodule.
http://www.medicines.org.uk/emc/medicine/28407
Canesten products containing fluconazole
SPCs for fluconazole products have been updated with data from study suggesting increased risk of
spontaneous abortion in women treated with it in 1st trimester. It should not be used during pregnancy/in
women of childbearing potential unless adequate contraception is used.
http://www.medicines.org.uk/emc/medicine/13959
Canesten products containing fluconazole
SPCs for fluconazole products have been updated with data from study suggesting increased risk of
spontaneous abortion in women treated with it in 1st trimester. It should not be used during pregnancy/in
women of childbearing potential unless adequate contraception is used.
http://www.medicines.org.uk/emc/medicine/13959
Copaxone (glatiramer acetate) Injection, Pre-filled Syringe
Glatiramer is no longer contraindicated in pregnancy. Current data indicate no malformative or feto/neonatal
toxicity, however no relevant epidemiological data are available. It is preferable to avoid the use during
pregnancy unless the benefit to the mother outweighs the risk to
http://www.medicines.org.uk/emc/medicine/30795
Daktarin (miconazole) Oral Gel
SPC has been updated to advise increases in INR and bleeding events have been reported in patients on oral
anticoagulants and miconazole (MC) oral gel. MC is systemically absorbed and is known to inhibit CYP2C9 and
CYP3A4 which can lead to prolonged effects of warfarin.
http://www.medicines.org.uk/emc/medicine/7301
Desferal (desferrioxamine mesilate) vials
Shelf life has increased from 18 to 36 months and storage conditions have changed from above 30ºC to above
25ºC.
http://www.medicines.org.uk/emc/medicine/2666
Dysport (botulinum type A toxin) 300U and 500U
SPC has been updated with new indication of axillary hyperhidrosis.
http://www.medicines.org.uk/emc/medicine/32114
Eperzan (albiglutide) 30 mg and 50 mg powder and solvent for solution for injection
SPC now notes dehydration, sometimes leading to renal impairment and acute renal failure, has been reported
and has occurred in patients without gastrointestinal side effects. Patients should be advised of this potential
risk and take precautions to avoid fluid depletion.
http://www.medicines.org.uk/emc/medicine/31399
Evorel (estradiol) 25, 50, 75 & 100 patches
Section 4.2 advises on the addition of approved oral progestogens (eg oral norethisterone, 1mg/day or
medroxyprogesterone acetate, 2.5mg/day), either on a cyclical or continuous basis for women with an intact
uterus for the prevention of adverse endometrial effects.
http://www.medicines.org.uk/emc/medicine/7235
Eperzan (albiglutide) 30 mg and 50 mg powder and solvent for solution for injection
SPC now notes dehydration, sometimes leading to renal impairment and acute renal failure, has been reported
and has occurred in patients without gastrointestinal side effects. Patients should be advised of this potential
risk and take precautions to avoid fluid depletion.
http://www.medicines.org.uk/emc/medicine/31399
Evorel (estradiol) 25, 50, 75 & 100 patches
Section 4.2 advises on the addition of approved oral progestogens (eg oral norethisterone, 1mg/day or
medroxyprogesterone acetate, 2.5mg/day), either on a cyclical or continuous basis for women with an intact
uterus for the prevention of adverse endometrial effects.
http://www.medicines.org.uk/emc/medicine/7235
Evra (norelgestromin/ ethinyl estradiol) transdermal patch
Sections 4.3, 4.4 and 4.5 include a contraindication for patients receiving drug combinations with
ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin. Concomitant use may increase the
risk of ALT elevations.
http://www.medicines.org.uk/emc/medicine/12124
Foscavir (foscarnet) 24 mg/ml Solution for Infusion
Number of adverse events added, including hypersensitivity, dehydration, tachycardia, gastrointestinal
haemorrhage, urticaria, angioedema, proteinuria, haematuria, erythema multiforme, toxic epidermal
necrolysis, Stevens Johnson syndrome, glomerulonephritis and nephrotic syndrome
http://www.medicines.org.uk/emc/medicine/174
Gilenya (fingolimod) 0.5mg hard capsules
Before initiation of fingolimod, in women of childbearing potential, a negative pregnancy test result needs to
be available. Counsellingshould be provided regarding the potential for serious risk to the foetus and the need
for effective contraception during treatment.
http://www.medicines.org.uk/emc/medicine/24443
Imodium (loperamide) 1 mg/5 ml oral solution
SPC has been updated to warn that cardiac events including QT prolongation and torsades de pointes have
been reported in association with overdose. Some cases had a fatal outcome. Patients should not exceed
recommended dose and/or recommended duration of treatment.
http://www.medicines.org.uk/emc/medicine/17607
Incruse (umeclidinium) 55 micrograms inhalation powder, pre-dispensed
Eye pain (rare frequency) and increased intraocular pressure (unknown frequency) have been added to SPC as
adverse effects.
http://www.medicines.org.uk/emc/medicine/29394
Komboglyze (saxagliptin, metformin) 2.5mg-850mg & 2.5mg-1000mg Tablets
Information on ‘saxagliptin add on to dapagliflozin plus metformin therapy’ and ‘saxagliptin and dapagliflozin
add on to metformin therapy’ has been added to section 5.1 and the indication rewritten to incorporate this
updated information.
http://www.medicines.org.uk/emc/medicine/27311
Incruse (umeclidinium) 55 micrograms inhalation powder, pre-dispensed
Eye pain (rare frequency) and increased intraocular pressure (unknown frequency) have been added to SPC as
adverse effects.
http://www.medicines.org.uk/emc/medicine/29394
Komboglyze (saxagliptin, metformin) 2.5mg-850mg & 2.5mg-1000mg Tablets
Information on ‘saxagliptin add on to dapagliflozin plus metformin therapy’ and ‘saxagliptin and dapagliflozin
add on to metformin therapy’ has been added to section 5.1 and the indication rewritten to incorporate this
updated information.
http://www.medicines.org.uk/emc/medicine/27311
Lioresal (baclofen) – all formulations
Sections 4.4, 4.6 and 4.8 include additional information on drug withdrawal symptoms in neonates exposed to
intrauterine levels of baclofen. Onset of scoliosis or worsening of pre-existing scoliosis has been reported in
patients treated specifically with Lioresal Intrathecal.
http://www.medicines.org.uk/emc/medicine/4113
Lyrica (pregabalin) capsules
Hepatobiliary disorders have been added to section 4.8. Adverse effects include elevated liver enzymes
(uncommon), jaundice (rare) and hepatic failure/hepatitis (very rare).
http://www.medicines.org.uk/emc/medicine/14651
Mirvaso (brimonidine) 3mg/g Gel
SPC now highlights that brimonidine gel should not be applied to irritated skin after laser surgery. Bradycardia
(rare) and dizziness (uncommon) have been added as potential adverse effects of treatment.
http://www.medicines.org.uk/emc/medicine/28682
MST (morphine sulphate) Continus tablets 5 mg, 10 mg, 15 mg, 30 mg, 60 mg, 100 mg, 200 mg
Pneumonia aspiration has been added to the list of symptoms of overdose.
http://www.medicines.org.uk/emc/medicine/1223
One-Alpha Drops (alfacalcidol)
In section 6.1 (List of excipients), dl-a-tocopherol is renamed to All-rac-a-tocopherol. The in use shelf life of the
product has been changed from 28 days to 4 months.
http://www.medicines.org.uk/emc/medicine/3352
Onglyza (saxagliptin) 2.5mg & 5mg film-coated tablets
Information has been added to section 5.1 on ‘saxagliptin add on to dapagliflozin plus metformin therapy’ and
on ‘saxagliptin and dapagliflozin added on to metformin therapy’.
http://www.medicines.org.uk/emc/medicine/22315
ORENCIA (abatacept) 125 mg solution for injection (pre-filled syringe)
ORENCIA, alone or in combination with methotrexate (MTX), is licensed for the treatment of active psoriatic
arthritis in adults when the response to previous DMARD therapy including MTX has been inadequate, and for
whom additional systemic therapy is not required.
http://www.medicines.org.uk/emc/medicine/27216
ORENCIA (abatacept) 125 mg solution for injection (pre-filled syringe)
ORENCIA, alone or in combination with methotrexate (MTX), is licensed for the treatment of active psoriatic
arthritis in adults when the response to previous DMARD therapy including MTX has been inadequate, and for
whom additional systemic therapy is not required.
http://www.medicines.org.uk/emc/medicine/27216
Prolia (denosumab)
Osteonecrosis of the external auditory canal (frequency unknown) has been reported with denosumab.
Possible risk factors include steroid use and chemotherapy and/or local risk factors such as infection or
trauma. SPC has been updated with information relating to when to re-evalaute patients after long term
treatment and risk of adverse outcomes such as osteonecrosis of the jaw and atypical femur fractures.
SPC has been updated to include advice about long-term use: Optimal total duration of antiresorptive
treatment for osteoporosis (incl both denosumab and bisphosphonates) has not been established. The need
for continued treatment should be re-evaluated particularly after >5 yrs.
http://www.medicines.org.uk/emc/medicine/23127
Propecia (finasteride) 1mg tablets
Section 4.4 includes a new warning statement under a new sub-heading of ‘Mood alterations and depression’
to reflect that cases of depression, mood alterations and suicidal ideation have been reported. Section 4.8 has
also been updated to include this information.
http://www.medicines.org.uk/emc/medicine/3680
Renvela (Sevelamer carbonate) powder for oral suspension
The SPC has been updated to highlight the licence extension for use in children and adolescents (>6 years of
age and a body surface area (BSA) of ≥0.75m2).
http://www.medicines.org.uk/emc/medicine/22782
Revestive (teduglutide)
SPC highlights that a 1.25 mg strength vial is available for paediatric use (patients with a body weight <20 kg).
Also, it is strongly recommended that the name and lot number of the product are recorded on each
administration.
http://www.medicines.org.uk/emc/medicine/29315
Sebivo (telbivudine) 600mg film-coated tablets
Rare post-marketing cases of lactic acidosis (LA) have been reported with telbivudine; more often secondary to
other serious conditions. Treatment should be discontinued when metabolic/LA of unknown aetiology occurs.
Benign digestive symptoms may be indicative of LA development.
http://www.medicines.org.uk/emc/medicine/19740
Revestive (teduglutide)
SPC highlights that a 1.25 mg strength vial is available for paediatric use (patients with a body weight <20 kg).
Also, it is strongly recommended that the name and lot number of the product are recorded on each
administration.
http://www.medicines.org.uk/emc/medicine/29315
Sebivo (telbivudine) 600mg film-coated tablets
Rare post-marketing cases of lactic acidosis (LA) have been reported with telbivudine; more often secondary to
other serious conditions. Treatment should be discontinued when metabolic/LA of unknown aetiology occurs.
Benign digestive symptoms may be indicative of LA development.
http://www.medicines.org.uk/emc/medicine/19740
Selincro (nalmefene) 18mg film-coated tablets
Section 4.7 has been amended and now notes that due to the possible occurrence of a number of adverse
effects, nalmefene may have minor to moderate influence on the ability to drive and use machines and
patients should exercise caution particular when starting treatment.
http://www.medicines.org.uk/emc/medicine/27609
Silkis (calcitriol) 3 micrograms per g ointment
The SPC now advises that caution must be used in patients receiving medications known to increase the serum
calcium level, e.g. thiazide diuretics, or medications with pharmacological effects impacted by a change in
calcium levels such as digoxin.
http://www.medicines.org.uk/emc/medicine/8621
Strensiq (asfotase) injection
SPC now highlights that treating physicians should inform a testing lab that a patient is being treated with
asfotase when ordering samples. Alkaline Phosphatase is a detection reagent in many assays, and if asfotase
alfa is present aberrant values could be reported
http://www.medicines.org.uk/emc/medicine/30861
Tivicay (dolutegravir) film-coated tablets
The shelf-life of Tivicay 10mg, 25mg, and 50mg tablets has been extended from 3 to 5 years, from 3 to 4 years
and from 2 to 5 years respectively.
http://www.medicines.org.uk/emc/medicine/28545
Uptravi (selexipag)
Sections 4.3, 4.4 and 4.5 have been updated with information on the concomitant use of strong inhibitors of
CYP2C8.
http://www.medicines.org.uk/emc/medicine/31963
Xagrid (anagrelide) 0.5mg hard capsule
SPC now warns that cases of pulmonary hypertension have been reported in patients treated with anagrelide.
Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating
and during anagrelide therapy.
http://www.medicines.org.uk/emc/medicine/15737
Uptravi (selexipag)
Sections 4.3, 4.4 and 4.5 have been updated with information on the concomitant use of strong inhibitors of
CYP2C8.
http://www.medicines.org.uk/emc/medicine/31963
Xagrid (anagrelide) 0.5mg hard capsule
SPC now warns that cases of pulmonary hypertension have been reported in patients treated with anagrelide.
Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating
and during anagrelide therapy.
http://www.medicines.org.uk/emc/medicine/15737
Xarelto (rivaroxaban) film coated tablets (all strengths)
Serious skin reactions, including Stevens-Johnson syndrome/Toxic Epidermal Necrolysis, have been reported.
The highest risk appears to be early in the course of therapy. Treatment should be discontinued at the first
appearance of a severe skin rash
http://www.medicines.org.uk/emc/medicine/21265
Xtandi (enzalutamide) 40mg capsules
Addition of seizure related information to sections 4.4/4.8. Caution should be used in patients with a history of
seizures or other predisposing factors. Risk of seizure may be increased in patients receiving concomitant
medicines that lower seizure threshold.
http://www.medicines.org.uk/emc/medicine/27912
Xultophy 100 units/ml insulin degludec + 3.6 mg/mL liraglutide solution for injection in a pre-filled pen
Use in hepatic impairment (HI) has been revised to state that Xultophy can be used in mild or moderate HI and
glucose monitoring is to be intensified and dose adjusted on individual basis. Due to liraglutide component, it
is not recommended for use in severe HI.
http://www.medicines.org.uk/emc/medicine/29493
Zometa (zoledronic acid) 4mg/100ml Solution for Infusion
Section 4.4 and 4.8 have been updated with new information on osteonecrosis of the external auditory canal
(bisphosphonate class adverse reaction, frequency, very rare) and other anatomical sites including femur and
hip (frequency, very rare).
http://www.medicines.org.uk/emc/medicine/25058
Zometa (zoledronic acid) 4mg/5ml Concentrate for Solution for Infusion
SPC revised to warn osteonecrosis (ON) of external auditory canal has been reported with bisphosphonates,
mainly linked to long-term therapy. There have also been sporadic reports of ON of other sites, including
hip/femur, mainly in adult cancer patients treated with Zometa.
http://www.medicines.org.uk/emc/medicine/14062
Zometa (zoledronic acid) 4mg/100ml Solution for Infusion
Section 4.4 and 4.8 have been updated with new information on osteonecrosis of the external auditory canal
(bisphosphonate class adverse reaction, frequency, very rare) and other anatomical sites including femur and
hip (frequency, very rare).
http://www.medicines.org.uk/emc/medicine/25058
Zometa (zoledronic acid) 4mg/5ml Concentrate for Solution for Infusion
SPC revised to warn osteonecrosis (ON) of external auditory canal has been reported with bisphosphonates,
mainly linked to long-term therapy. There have also been sporadic reports of ON of other sites, including
hip/femur, mainly in adult cancer patients treated with Zometa.
http://www.medicines.org.uk/emc/medicine/14062
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance Tool June 2017To request this safety tool, or for more information about this tool, to make a comment, or share a safety issue please contact [email protected]
Brimonidine gel (Mirvaso): risk of systemic cardiovascular effects; not to be applied to damaged
skin Proposed action
MHRA | 21-June-2017
Action taken
Status
https://www.gov.uk/drug-safety-update/brimonidine-gel-mirvaso-risk-of-systemic-cardiovascular-effects-not-to-be-applied-to-damaged-skin Date completed
Denosumab (Prolia, Xgeva▼): reports of osteonecrosis of the external auditory canal Proposed action
MHRA | 21-June-2017
Action taken
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search Other• cases of bradycardia, hypotension (including orthostatic hypotension), and dizziness after application
of brimonidine gel have been reported, some of which required hospitalisation
• some cases were associated with application of brimonidine gel after laser procedures to the skin,
which possibly caused increased absorption of the gel
• warn patients not to apply brimonidine gel to irritated or damaged skin, including after laser therapy
to the skin
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search Other• the possibility of osteonecrosis of the external auditory canal should be considered in patients
receiving denosumab who present with ear symptoms including chronic ear infections or in those
with suspected cholesteatoma
• possible risk factors include steroid use and chemotherapy, with or without local risk factors such as
infection or trauma
• advise patients to report any ear pain, discharge from the ear, or an ear infection during denosumab
treatment
• report cases of osteonecrosis of any bone suspected to be associated with denosumab or any other
medicine on a Yellow Card
Status
https://www.gov.uk/drug-safety-update/denosumab-prolia-xgeva-reports-of-osteonecrosis-of-the-external-auditory-canal Date completed
e-cigarettes and refill containers (e-liquids): report suspected side effects and safety concerns Proposed action
MHRA | 21-June-2017
Action taken
Status
https://www.gov.uk/drug-safety-update/e-cigarettes-and-refill-containers-e-liquids-report-suspected-side-effects-and-safety-concerns Date completed
Influenza Season 2016/17: Use of Antiviral Medicines Proposed action
CAS | 12-Jun-2017
Action taken
Status
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102782 Date completed
• the possibility of osteonecrosis of the external auditory canal should be considered in patients
receiving denosumab who present with ear symptoms including chronic ear infections or in those
with suspected cholesteatoma
• possible risk factors include steroid use and chemotherapy, with or without local risk factors such as
infection or trauma
• advise patients to report any ear pain, discharge from the ear, or an ear infection during denosumab
treatment
• report cases of osteonecrosis of any bone suspected to be associated with denosumab or any other
medicine on a Yellow Card
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherMembers of the public and healthcare professionals can use the Yellow Card Scheme website to report any
suspected side effects or safety concerns with e-cigarettes and the e-liquids used for vaping.
These issues could include:
• suspected side-effects that occurred after the use of e-cigarettes and e-liquids
• harm to children or non-users, including accidental poisoning
• safety issues or defects with e-cigarette devices
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherPrescribers working in primary care and community pharmacists should no longer prescribe or supply
antiviral medicines for the prophylaxis and treatment of influenza on an FP10 prescription form
Risk minimisation materials: Physician prescribing checklist for Mysimba (8mg naltrexone /90mg
bupropion) prolonged-release tablets Proposed action
electronic Medicines Compendium | 14-Jun-2017
Action taken
Status
http://www.medicines.org.uk/emc/RMM.886.pdf Date completed
Risk management materials for Valdoxan® (agomelatine) - liver function monitoring and drug
interactions Proposed action
electronic Medicines Compendium | 19-Jun-2017
Action taken
Status
http://www.medicines.org.uk/emc/RMM.64.pdf Date completed
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherThis checklist ensures the appropriate contraindications and special warnings/precautions are considered
when prescribing Mysimba prolonged-release tablets.
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherNew guidance for healthcare professionals has been provided for monitoring liver function in patients before
and during treatment with Valdoxan. Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine,
ciprofloxacin) is also contraindicated with Valdoxan.
Educational Risk Minimisation Materials: Prescribers' Administration Guide for Qutenza® Proposed action
electronic Medicines Compendium | 22-Jun-2017
Action taken
Status
http://www.medicines.org.uk/emc/RMM.558.pdf Date completed
Summary of Product Characteristics Updates Proposed action
electronic Medicines Compendium | Jun-2017
Action taken
Status
Date completed
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherPrescribers should refer to this administration guide before administering Qutenza. It covers warnings and
precautions for use, practice precautions, briefing the patient, correct application of patch, managing
treatment-associated discomfort, and patient follow-up.
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search Other
Revised SPC: Ganfort® (bimatoprost and timolol) preparations
The adverse events of asthma exacerbation and chronic obstructive pulmonary disease (COPD) exacerbation
have been added to section 4.8.
http://www.medicines.org.uk/emc/medicine/28209
Revised SPC: Zocor® (simvastatin) tablets
Simvastatin should now not be used within 7 days of stopping fusidic acid as well as avoiding concomitant
administration. Also, simvastatin dose adjustments should be considered in concomitant administration of
Breast Cancer Resistant Protein inhibitors (eg elbasvir, grazoprevir)
http://www.medicines.org.uk/emc/medicine/1201
Revised SPC: Reminyl® (galantamine) – all presentations
Complete atrioventricular block is now listed as a rare adverse reaction.
http://www.medicines.org.uk/emc/medicine/10335
Revised SPC: Simvastatin Rosemont 20mg/5ml and 40mg/5ml Oral Suspension
Section 4.2 now advises that simvastatin Rosemont oral suspension is suitable for administration via
nasogastric or percutaneous endoscopic gastrostomy tubes.
http://www.medicines.org.uk/emc/medicine/32577
Revised SPC: Simvastatin Rosemont 20mg/5ml and 40mg/5ml Oral Suspension
Section 4.2 now advises that simvastatin Rosemont oral suspension is suitable for administration via
nasogastric or percutaneous endoscopic gastrostomy tubes.
http://www.medicines.org.uk/emc/medicine/32577
Revised SPC: Actiq® (fentanyl) Lozenges
The SPC now states use in those aged <16 years is not recommended. Additional side-effects listed/discussed
include adrenal insufficiency, androgen deficiency, neonatal withdrawal syndrome and anaphylaxis and
hypersensitivity.
http://www.medicines.org.uk/emc/medicine/30554
Revised SPC: Losec® (omeprazole) – all formulations
Section 4.8 has been updated with a new adverse effect - benign fundic gland polyps (frequency common).
http://www.medicines.org.uk/emc/medicine/7275
Revised SPC: Neoclarityn® (desloratadine) – all formulations
Section 4.4 contains information on administration in patients with medical/familial history of seizure and
discontinuation in patients who experience a seizure. Section 4.8 has been updated with abnormal behaviour
and aggression as potential adverse events (frequency unknown).
http://www.medicines.org.uk/emc/medicine/9290
Revised SPCs: Solu-Medrone® (methylprednisolone) preparations
Sections 4.4 and 4.5 have been revised to include warnings concerning co-treatment with CYP3A inhibitors
(including cobicistat-containing products), which is expected to increase the risk of systemic side-effects. The
combination should be avoided unless benefit outweighs risk.
http://www.medicines.org.uk/emc/medicine/27656
Revised SPC: Pevanti® (prednisolone) tablets
SPC highlights that visual disturbance may occur with corticosteroids. If blurred vision or other visual
disturbances occur, the patient should be considered for referral to an ophthalmologist. Possible causes may
include cataract, glaucoma or central serous chorioretinopathy.
http://www.medicines.org.uk/emc/medicine/30012
Revised SPC: DuoResp Spiromax® (budesonide/formoterol) inhalation powder
Sections 4.4 and 4.8 note that visual disturbance may occur with corticosteroids.If blurred vision or other
visual disturbances occur, the patient should be considered for referral to an ophthalmologist Possible causes
may include cataract, glaucoma or central serous chorioretino
http://www.medicines.org.uk/emc/medicine/29187
Revised SPC: DuoResp Spiromax® (budesonide/formoterol) inhalation powder
Sections 4.4 and 4.8 note that visual disturbance may occur with corticosteroids.If blurred vision or other
visual disturbances occur, the patient should be considered for referral to an ophthalmologist Possible causes
may include cataract, glaucoma or central serous chorioretino
http://www.medicines.org.uk/emc/medicine/29187
Revised SPC: Brevinor® (norethisterone/ethinylestradiol) Tablets
SPC has been updated with information on interaction between combined hormonal contraceptives containing
ethinylestradiol with products containing ombitasvir/paritaprevir/ritonavir (Viekirax) and dasabuvir with or
without ribavirin, which may increase risk of ALT elevations.
http://www.medicines.org.uk/emc/medicine/1899
Revised SPC: Symbicort® (budesonide/formoterol) Turbohaler Inhalation powder (all strengths)
The storage restriction has been removed from SPC. Previously it had advised that device should not be stored
at temperatures above 30 degrees and that the container should be kept tightly closed to guard against
development of moisture.
http://www.medicines.org.uk/emc/medicine/4820
Revised SPC: Nexium® (esomeprazole) preparations
Fundic gland polyps (benign) has been added as an undesirable effect.
http://www.medicines.org.uk/emc/medicine/24695
Revised SPC: Qtern® (saxagliptin and dapagliflozin) 5 mg/10 mg film-coated tablets
Section 4.4 now notes that an increase in cases of lower limb amputation (primarily of the toe) has been
observed in ongoing long-term, clinical studies with another SGLT2 inhibitor. It is unknown whether this
constitutes a class effect.
http://www.medicines.org.uk/emc/medicine/32750
Revised SPC: Avodart® (dutasteride) 0.5mg soft capsules
Sections 4.4 and 5.1 of SPC have been updated with data from trials or reports during post-marketing period,
about the risk of prostate and male breast cancer, and heart failure.
http://www.medicines.org.uk/emc/medicine/11618
Revised SPC: Eperzan® (albiglutide) powder and solvent for solution for injection
This SPC now advises that dehydration, sometimes leading to renal impairment and acute renal failure, has
been reported in patients treated with albiglutide. Patients should be advised of this risk and advised to take
precautions to avoid fluid depletion
http://www.medicines.org.uk/emc/medicine/31399
Revised SPC: Eperzan® (albiglutide) powder and solvent for solution for injection
This SPC now advises that dehydration, sometimes leading to renal impairment and acute renal failure, has
been reported in patients treated with albiglutide. Patients should be advised of this risk and advised to take
precautions to avoid fluid depletion
http://www.medicines.org.uk/emc/medicine/31399
Revised SPC: Lumigan® (bimatoprost) 0.1mg/ml
Eye discharge, increased lacrimation, eye oedema and foreign body sensation in the eyes have been added as
potential adverse effects of treatment (frequency unknown)
http://www.medicines.org.uk/emc/medicine/22807
Revised SPC: Trulicity® (dulaglutide) solution for injection
Angioedema has been added as a rare potential adverse effect of treatment.
http://www.medicines.org.uk/emc/medicine/29747
Revised SPC: Combodart (0.5 mg dutasteride/0.4 mg tamsulosin) hard capsules
Sections 4.4 and 5.1 of SPC have been updated with data from trials or reports during post-marketing period,
about the risk of prostate and male breast cancer, and heart failure with dutasteride.
http://www.medicines.org.uk/emc/medicine/22943
Revised SPC: Intuniv (guanfacine) 1 mg, 2 mg, 3 mg, 4 mg prolonged-release tablets
Erectile dysfunction has been added to SPC as an undesirable effect of unknown frequency.
http://www.medicines.org.uk/emc/medicine/31294
Revised SPC: Xgeva® (denosumab)
SPC updated to warn osteonecrosis of external auditory canal has been reported with denosumab. This should
be considered in patients with ear symptoms including chronic ear infections. Risk factors include steroids and
chemotherapy and/or local risk factors, e.g. infection/trauma
http://www.medicines.org.uk/emc/medicine/24755
Revised SPC: NovoRapid 100 units/ml in a vial, NovoRapid Penfill 100 units/ml, NovoRapid FlexPen 100
units/ml,
The storage information for NovoRapid FlexPen/NovoRapid FlexTouch has been updated to say that it can be
stored in a refrigerator (previously stated that it should not be refrigerated). [Information for NovoRapid
vial/NovoRapid Penfill and NovoRapid PumpCart remains unchanged].
http://www.medicines.org.uk/emc/medicine/25033
Revised SPC: NovoRapid 100 units/ml in a vial, NovoRapid Penfill 100 units/ml, NovoRapid FlexPen 100
units/ml,
The storage information for NovoRapid FlexPen/NovoRapid FlexTouch has been updated to say that it can be
stored in a refrigerator (previously stated that it should not be refrigerated). [Information for NovoRapid
vial/NovoRapid Penfill and NovoRapid PumpCart remains unchanged].
http://www.medicines.org.uk/emc/medicine/25033
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Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance ToolMay 2017To request this safety tool, or for more information about this tool, to make a comment, or share a safety issue please contact [email protected]
Educational Risk Minimisation Materials for Clexane (enoxaparin sodium) Proposed action
NICE | 15-May-2017
http://www.medicines.org.uk/emc/RMM.825.pdf Action taken
Status 1
Date completed
Educational Risk Minimisation Materials for Levetiracetam 100mg/ml oral solution Proposed action
NICE | 12-May-2017
http://www.medicines.org.uk/emc/RMM.823.pdf Action taken
Status 1
Date completed
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Practice audit/search Other
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Practice audit/search Other
Dear Healthcare Professional” letter notes that enoxaparin is expressed both in international units (IU) of anti-
Xa activity and in milligrams (mg); and that its use in severe renal impairment is not recommended. There is
also further clarification on dose regimens for DVT/PE.
‘Dear Healthcare Professional’ letter covers overdose due to medication errors and how to reduce risk. Where
cause of reported accidental overdosing was known, it was either due to use of inappropriate syringe or
misunderstanding of caregiver about how to properly measure dose.
Risk management materials for Daxas (roflumilast) 500 micrograms film-coated tablets:
Information for prescribers and patientsProposed action
NICE | 09-May-2017
http://www.medicines.org.uk/emc/RMM.817.pdf
Action taken
Status 1
Date completed
lOptimise Rx/ScriptSwitchNewsletter
Practice audit/search OtherThis document contains information for healthcare professionals describing key prescribing and monitoring
information (especially monitoring weight) to consider when prescribing roflumilast.
Finasteride: rare reports of depression and suicidal thoughts Proposed action
NICE | 26-May-2017
Action taken
Status 1
Date completed
https://www.gov.uk/drug-safety-update/finasteride-rare-reports-of-depression-and-suicidal-thoughts
Accu-Chek® Insight insulin pumps - updated information for battery management Proposed action
MHRA | 02-May-2017
Action taken
Status 1
Date completed
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102722
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Practice audit/search Other
We have received reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1 mg
(Propecia) for male pattern hair loss. Be aware that depression is also associated with finasteride 5 mg
(Proscar).
Advice for healthcare professionals:
• Since finasteride has been marketed there have been a number of spontaneous adverse drug reaction
reports suggesting a possible link to depression, and in rare cases, suicidal thoughts
• Advise patients to stop finasteride 1 mg (Propecia) immediately if they develop depression and inform
a healthcare professional
• Be aware that the product information for finasteride 5 mg (Proscar) already lists depression as a
possible adverse reaction
Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to
improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
Action
• Identify all users of Accu-Chek Insight insulin pumps.
• Ensure that all patients and carers:
o Receive the manufacturer’s Field Safety Notice (FSN)
o Understand the instructions detailed in the FSN and follow the advice given by the
manufacturer
o Use Energizer® Ultimate lithium batteries (1.5V AAA / FR03) provided by the manufacturer
and follow the steps described in the handling instructions in the FSN
• Contact Roche if you experience unexpected pump shut down or rapid battery depletion.
• Return the FSN acknowledgment form to Roche as currently the manufacturer hasn’t received
enough responses.
Class 2 Medicines Recall: Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops Proposed action
CAS | 18-May-2017
https://assets.publishing.service.gov.uk/media/591eb86be5274a5e5100005a/Sodium_Cromoglicate_13.5_mL_Eye_Drops.pdf
Action taken
Status 1
Date completed
Medical Device Alert: All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device
shutting down unexpectedly during patient treatment and possible failure to deliver therapyProposed action
CAS | 18-May-2017
Action taken
https://assets.publishing.service.gov.uk/media/591da3bd40f0b63e0b00005f/MDA_-_2017-013_Final.pdf
Status 1
Date completed
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Practice audit/search Other
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search Other
FDC International Ltd is recalling the batches listed as a precautionary measure due to a precipitate observed
in the bottles.
1. Identify all LIFEPAK 1000 defibrillators in your possession.
2. Ensure that all those responsible for the AED follow the instructions in the manufacturer’s Field Safety
Notice (FSN).
3. If you have already acted on this FSN, no further action is required.
Public Health England: Management of infection guidance for primary care for consultation and
local adaptation: UpdateProposed action
PHE | 10-May-2017
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/612743/Managing_common_infections.pdfAction taken
Status 1
Date completed
Trimethoprim and Methotrexate: never co-prescribe Proposed action
CCG | 31-May-2017
Action taken
Status 1
Date completed
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Practice audit/search Other
Optimise Rx/ScriptSwitchNewsletter
Practice audit/search Other
Following a review of new evidence detailing increased risk of spontaneous abortion with azithromycin,
clarithromycin, metronidazole, tetracyclines, quinolones and sulphonamides PHE guidance has been updated
on antibiotic use pregnancy.
The BNF states that there is an increased risk of haematological toxicity when methotrexate is given with
trimethoprim (also with co-trimoxazole).
Several cases of severe bone marrow depression (some of which were fatal) have been reported in patients
given low-dose methotrexate and trimethoprim or co-trimoxazole (sulfamethoxazole with trimethoprim).
This potentially fatal interaction can occur even with short courses or low doses of trimethoprim.
Pancytopenia has also been reported in a few patients given co-trimoxazole shortly after stopping
methotrexate.
Bone marrow suppression can occur abruptly, leading to:
• Life threatening infections, as the body cannot produce leukocytes in response to invading bacteria
and viruses.
• Anaemia due to a lack of red blood cells.
• Spontaneous severe bleeding due to a deficiency of platelets.
Prescribers should be aware that some information sources do not stress the importance of this interaction.
EMIS Web highlights this drug interaction with a high severity warning.
SPC updates Proposed action
NICE | 30-May-2017
Action taken
Status 1
Date completed
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Practice audit/search Other
Revised SPC: Anusol HC (bismuth, zinc oxide and hydrocortisone) preparations
SPC now highlights that visual disturbance has been reported with systemic and topical corticosteroid use.
Patients with such symptoms should be considered for ophthalmology referral.
http://www.medicines.org.uk/emc/medicine/10493
Revised SPC: Avelox (moxifloxacin) preparations
Sections 4.4 (special warnings and precautions) and 4.8 (undesirable effects) have been updated to include the
adverse reaction vasculitis with a frequency very rare and to modify the warnings on hypersensitivity reactions
and peripheral neuropathy.
http://www.medicines.org.uk/emc/medicine/22827
Revised SPC: Briviact (brivaracetam) – all formulations
Section 4.8 warns reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small
number of brivaracetam patients during clinical development.
https://www.medicines.org.uk/emc/medicine/31452
Revised SPC: Budenofalk (budesonide) preparations
Various additions, including side-effects (blurred vision, aggression, psychomotor hyperactivity and anxiety).
Interaction with CYP3A inhibitors (increased risk of systemic side-effects) and further detail in the pregnancy
and breast-feeding sections.
http://www.medicines.org.uk/emc/medicine/18725
Revised SPC: Dalacin C (clindamycin) capsules
Dose modification is not necessary in renal or hepatic insufficiency (4.2). Amended warnings made on
hypersensitivity and severe skin reactions (4.4). C. difficile colitis, anaphylactic shock, anaphylactic reaction,
hypersensitivity and angioedema have been added as adverse events (4.8)
http://www.medicines.org.uk/emc/medicine/12425
Revised SPC: Diflucan (fluconazole) all formulations
Section 4.4 updated with information on QT prolongation, reported during post-marketing surveillance.
Section 4.5 notes that administration of fluconazole with amiodarone may increase QT prolongation; caution
therefore advised, notably with high dose fluconazole (800 mg).
http://www.medicines.org.uk/emc/medicine/25675
Revised SPC: Epanutin (phenytoin) – various presentations
Information regarding the potential need for dose modification in elderly patients, and dose modification
and/or measurement of unbound phenytoin levels in patients with renal or hepatic diseases,
hypoalbuminemia, and/or hyperbilirubinemia has been added.
http://www.medicines.org.uk/emc/medicine/13289
Revised SPC: Epanutin (phenytoin) – various presentations
Information regarding the potential need for dose modification in elderly patients, and dose modification
and/or measurement of unbound phenytoin levels in patients with renal or hepatic diseases,
hypoalbuminemia, and/or hyperbilirubinemia has been added.
http://www.medicines.org.uk/emc/medicine/13289
Revised SPC: Epanutin (phenytoin) Infatabs
Sections 4.2 and 4.4 now includes information regarding the potential need for dose modification and/or
measurement of unbound phenytoin due to potential for elevated concentration of unbound phenytoin in
patients with renal or hepatic diseases, and hypo/hyperalbuminaemia
http://www.medicines.org.uk/emc/medicine/13303
Revised SPC: Firmagon (degarelix) 120mg Injection
SPC updated to warn that serious injection site reactions were very rarely reported such as injection site
infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage.
http://www.medicines.org.uk/emc/medicine/21701
Revised SPC: Forxiga (dapagliflozin propanediol monohydrate) 5 mg & 10 mg film coated tablets
Section 4.4 advises of an increase in cases of lower limb amputation (primarily of the toe) reported in ongoing
long-term, clinical studies with another SGLT2 inhibitor, but it is unknown whether this constitutes a class
effect. Counsel patients on routine preventative foot care.
http://www.medicines.org.uk/emc/medicine/27188
Revised SPC: Heminevrin (clomethiazole) 192 mg Capsules
Section 4.5 now warns of possible interactions with CYP2E1-substrates.
http://www.medicines.org.uk/emc/medicine/33156
Revised SPC: Invokana (canagliflozin) 100 mg and 300 mg film-coated tablets
Section 4.4 has been revised to include class labelling text on diabetic ketoacidosis - Rare cases of diabetic
ketoacidosis, including life-threatening and fatal cases, have been reported in patients treated with SGLT2
inhibitors, including canagliflozin.
http://www.medicines.org.uk/emc/medicine/28400
Revised SPC: Jardiance (empagliflozin) 10 mg and 25 mg film-coated tablets
The SPC now notes (section 4.4) that an increase in cases of lower limb amputation (primarily of the toe) has
been observed in ongoing long-term clinical studies with another SGLT2 inhibitor. It is unknown whether this
constitutes a class effect.
http://www.medicines.org.uk/emc/medicine/28973
Revised SPC: Nasonex (mometasone furoate monohydrate) 50 micrograms/actuation Nasal Spray,
Suspension
Section 4.5 now includes information regarding the expected increased risk of systemic side effects after co-
treatment with CYP3A inhibitors, including cobicistat-containing products. The combination should be avoided.
http://www.medicines.org.uk/emc/medicine/9748
Revised SPC: Nasonex (mometasone furoate monohydrate) 50 micrograms/actuation Nasal Spray,
Suspension
Section 4.5 now includes information regarding the expected increased risk of systemic side effects after co-
treatment with CYP3A inhibitors, including cobicistat-containing products. The combination should be avoided.
http://www.medicines.org.uk/emc/medicine/9748
Revised SPC: Nuvaring (etonogestrel and ethinylestradiol) vaginal delivery system
Sections 4.3, 4.4 and 4.5 contraindicate the co-administration of ombitasvir/paritaprevir/ritonavir and
dasabuvir with ethinyloestradiol because of the increased risk of elevated ALT.
http://www.medicines.org.uk/emc/medicine/21419
Revised SPC: Octasa (mesalazine) 400mg MR Tablets
Pleurisy has been added as a potential adverse effect from treatment (frequency unknown).
http://www.medicines.org.uk/emc/medicine/27094
Revised SPC: Pradaxa (dabigatran etexilate) hard capsules – all strengths
The colour of Pradaxa caps have been changed according to dosage strength, as part of the worldwide
harmonisation process. The 75mg cap is white, the 110mg cap is light blue and the 125mg cap is two-tone light
blue/white. Sunset yellow colouring has been removed from the casing.
http://www.medicines.org.uk/emc/medicine/20760
Revised SPC: Soolantra (ivermectin) 10mg/g Cream
Contact dermatitis has been added as a potential adverse effect from treatment (frequency unknown).
http://www.medicines.org.uk/emc/medicine/30353
Revised SPC: Tresiba (insulin degludec) 100 units/mL, 200 units/mL Pre filled (FlexTouch), 100 units/mL
Cartridge (Penfill)
Dosing information has been extensively revised: In patients with type 2 diabetes, dose reduction of 20%
based on previous basal insulin dose followed by individual dosage adjustments should be considered when
transferring from twice-daily basal insulin or from insulin glargine.
http://www.medicines.org.uk/emc/medicine/27360
Revised SPC: Vokanamet (canagliflozin with metformin) 50 mg/850 mg, 50 mg/1000 mg, 150 mg/850 mg and
150 mg/1000 mg film coated tablets
Section 4.4 has been revised to include class labelling text on diabetic ketoacidosis - Rare cases of diabetic
ketoacidosis, including life-threatening and fatal cases, have been reported in patients treated with SGLT2
inhibitors, including canagliflozin.
http://www.medicines.org.uk/emc/medicine/29368
Revised SPC: Xigduo (dapagliflozin and metformin) film coated tablets
Section 4.4 contains new clinical information on risk of lower limb amputations; patients should be counselled
on routine preventative foot care. Rash has been added as a common adverse event (≥ 1/100 to < 1/10).
http://www.medicines.org.uk/emc/medicine/28667
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance ToolApril 2017
Valproate and developmental disorders: new alert asking for patient review and
further consideration of risk minimisation measures Date of alert Status Date completed
Medicines and Healthcare products Regulatory Agency 24-Apr-2017
Proposed action
Action taken
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAlert.aspx?AlertID=102582
https://www.gov.uk/drug-safety-update/valproate-and-developmental-disorders-new-alert-asking-for-patient-
review-and-further-consideration-of-risk-minimisation-measures
Newsletter Prescribing decision support Search/auditPatient Safety Alerts have now been issued asking all organisations to undertake systematic
identification of women and girls taking valproate. Babies born to mothers who take
valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of
developmental disability and a 10% risk of birth defects.
Advice for healthcare professionals
• Do not prescribe valproate medicines for epilepsy or bipolar disorder in women and
girls unless other treatments are ineffective or not tolerated; migraine is not a
licensed indication.
• Ensure women and girls taking valproate medicines understand the 30–40% risk of
neurodevelopmental disorders and 10% risk of birth defects and are using effective
contraception.
• Valproate use in women and girls of childbearing potential must be initiated and
supervised by specialists in the treatment of epilepsy or bipolar disorder.
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance ToolApril 2017
Mucodyne® Paediatric Syrup 250 mg/5 mL (carbocisteine oral liquid): new double-
strength presentation - check dose volume to ensure appropriate dose is given Date of alert Status Date completed
Medicines and Healthcare products Regulatory Agency 24-Apr-2017
Proposed action
Action taken
https://assets.publishing.service.gov.uk/media/58fa19a7ed915d06b00001a2/MucodynePaediatricReformulati
on_October_2016.pdf
Newsletter Prescribing decision support Search/auditSummary
Mucodyne Paediatric Syrup has been re-launched and has double the concentration of
the active ingredient carbocisteine per millilitre compared with the previous formulation.
To reduce the risk of accidental overdose, dose volumes must be checked to ensure the
appropriate dose is administered, especially if they have used Mucodyne Syrup in the past.
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance ToolApril 2017
Evidence of harm from fentanyl-contaminated heroin Date of alert Status Date completed
Central Alerting System: CMO Messaging 27-Apr-2017
Proposed action
Action taken
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAlert.aspx?AlertID=102588
Newsletter Prescribing decision support Search/auditThis alert advises of the availability of, and harms from, heroin that has been mixed with
fentanyl or carfentanyl, both unusually potent synthetic opioids.
There is significant evidence from a small number of post-mortem results of recent drug user
deaths and from police seizures that some heroin may contain fentanyl or carfentanyl added
by dealers. These are highly potent synthetic opioids and very small amounts can cause
severe or even fatal toxicity.
Those of you in contact with heroin users should be alert to the increased possibility of
overdose arising from heroin cut with these synthetic opioids, be able to recognise possible
symptoms of overdose and respond appropriately.
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright © Midlands and Lancashire Commissioning Support Unit
Medicines Safety Assurance ToolApril 2017
Medicines Safety Assurance Tool (MASTER): March 2017
Date of Alert Title of Alert Source of Alert
22.03.2017
SGLT2 inhibitors:
updated advice on
increased risk of lower-
limb amputation (mainly
toes)
MHRA
22.03.2017
Launch of pilot
reporting scheme for
harms associated with
illicit drugs, particularly
new psychoactive
substances
MHRA
27.03.2017Pradaxa® capsule
colour changeManufacturer Letter
29.03.2017
Class 2 Medicines
Recall:
Diclo-SR 75 Tablets
(Diclofenac Sodium)
MHRA
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright ©Midlands and Lancashire CSU
Medicines Safety Assurance Tool (MASTER): March 2017
Summary of Alert
SGLT2 Inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes)
Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes.
Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect.
Preventive foot care is important for all patients with diabetes.
Advice to Healthcare Professionals:
• carefully monitor patients receiving canagliflozin who have risk factors for amputation, such as poor control of
diabetes and problems with the heart and blood vessels
• consider stopping canagliflozin if patients develop foot complications such as infection, skin ulcers,
osteomyelitis, or gangrene
• advise patients receiving any sodium-glucose co-transporter 2 (SGLT2) inhibitor about the importance of
routine preventive foot care and adequate hydration
• continue to follow standard treatment guidelines (https://www.nice.org.uk/guidance/ng19) for routine
preventive foot care for people with diabetes
• report any suspected side effect with SGLT2 inhibitors or any other medicine on a Yellow Card
For further information please click the title in the alert column.
Launch of pilot reporting scheme for harm associated with illicit drugs, particularly new psychoactive
substances
The MHRA are launching a pilot scheme for healthcare professionals in the UK to report suspected adverse
reactions to illicit drugs, particularly new psychoactive substances.
A pilot reporting website, the Report Illicit Drug Reaction form (https://report-illicit-drug-reaction.phe.gov.uk/),
will be available for 1 year for healthcare professionals across the UK who come into contact with patients
experiencing harm associated with use of illicit drugs, particularly new psychoactive substances. The pilot aims
to better collect data on harms from illicit drug use, to support provision of clinical guidance to professionals. For
further information please click the title in the alert column.
Pradaxa® capsule colour change
The manufacturer of dabigatran (Pradaxa®) has written to healthcare professionals to advise that the colour of
the capsule is being changed to improve patient safety.
Dabigatran is available in three strengths, 75mg, 110mg and 150mg. Previously the capsule shell was the same
colour for all three strengths with a difference in size and imprint text. The new colour will see the 75mg capsule
coloured white, the 110mg light blue and the 150mg two-tone white and light blue. The size and text imprint will
remain the same. The changes have also removed sunset yellow as a colouring agent.
For further information patient support materials are available from company representatives or direct from the
company by emailing [email protected] or calling 01344 742 579.
Class 2 Medicines Recall: Diclo-SR 75 Tablets ® (Diclofenac Sodium)
Strides Pharma UK Ltd trading as Co-pharma is recalling the batches (7226423, 7226424, 7226425, 7227697,
7227698) as a precautionary measure due to high trending stability results obtained for the impurity test.
All remaining packs of the listed
batches should be quarantined and returned to your supplier. For further information please click the titile
in the alert column.
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
KEY
The information displayed
on the left hand side is in
order of risk (top indicating
highest risk)
Medicines Safety Assurance Tool (MASTER): Feb 2017
Date of Alert Title of Alert Source of Alert
01.02.2017
Alka-Seltzer Original &
Alka-Seltzer XS - recall
of some batches due to
an issue with the blister
foil
MHRA
06.03.2017 SPC Updates NICE
16.02.2017Precautionary recall of
Ergometrine InjectionsMHRA
21.02.2017
Hyoscine butylbromide
(Buscopan) injection:
risk of serious adverse
effects in patients with
underlying cardiac
disease
MHRA
23.02.2017Precautionary recall of
Viridal Duo Powder and
Solvent for Injection
MHRA
08.02.2017
Oxylog 3000 And
Oxylog 3000 Plus
Ventilator - Risk Of
Failure
MHRA
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright ©Midlands and Lancashire CSU
Medicines Safety Assurance Tool (MASTER): Feb 2017
Summary of Alert
Bayer plc is voluntarily recalling batches due to an issue with the blister foil. A problem with the blistering
process has resulted in the potential for small holes or cracks being present in the aluminum layer of the tablet
blister material, which are not visible to the consumer. This could result in compromise of the moisture barrier
provided by the aluminum layer. Bayer has assessed this defect as unlikely to pose a safety risk for consumers;
therefore affected batches are not being recalled to patient level.
Action for healthcare professionals: All remaining units of the affected batches should immediately be
quarantined. Bayer is contacting potentially affected customers by letter and will arrange uplift of affected stock
following receipt of a form listing affected stock in hand.
For further information please click the title in the alert column.
SPC Updates (Primary Care)
Revised SPC: Exviera (dasabuvir) 250 mg film-coated tablets
SPC has been updated with warning that cases of hepatitis B virus (HBV) reactivation, some of them fatal, have
been reported during or after treatment with direct acting antiviral agents. HBV screening should be performed
in all patients before initiation of treatment.
Revised SPC: Olysio (simeprevir) 150mg hard capsules
SPC has been updated with warning that cases of hepatitis B virus (HBV) reactivation, some of them fatal, have
been reported during or after treatment with direct acting antiviral agents. HBV screening should be performed
in all patients before initiation of treatment.
Revised SPC: Viekirax (12.5 mg ombitasvir/75mg paritaprevir /50 mg ritonavir) film-coated tablets
SPC has been updated with warning that cases of hepatitis B virus (HBV) reactivation, some of them fatal, have
been reported during or after treatment with direct acting antiviral agents. HBV screening should be performed
in all patients before initiation of treatment.
Recall of Ergometrine Injections by hameln pharmaceuticals limited, because the contents of some ampoules
may not comply with the required specification.
For further information please click the title in the alert column.
Prescribing information has been updated to help to minimise the risk of serious adverse reactions in patients
with cardiac disease.
Advice for healthcare professionals:
• hyoscine butylbromide injection can cause serious adverse effects including tachycardia, hypotension, and
anaphylaxis
• these adverse effects can result in a fatal outcome in patients with underlying cardiac disease, such as those
with heart failure, coronary heart disease, cardiac arrhythmia, or hypertension
• hyoscine butylbromide injection should be used with caution in patients with cardiac disease
• monitor these patients, and ensure that resuscitation equipment, and personnel who are trained how to use
this equipment, are readily available
• hyoscine butylbromide injection remains contraindicated in patients with tachycardia
For further information please click the title in the alert column.
UCB Pharma Limited is voluntarily recalling the Viridal Duo Powder and Solvent for Injection (10mcg/ml and
40mcg/ml) above batches as a precautionary measure due to a possible issue with the integrity of the cap seal
which may result in a lack of sterility assurance. The company has received no relevant reports of adverse
reactions or product complaints associated with any UK batches to date. Remaining stock of the listed batches
should be quarantined and returned to the original supplier for credit. Patients are asked to return packs from
affected batches to their community pharmacist. Limited replacement stock is available through wholesalers.
For further information please click the title in the alert column.
Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of
the control knobs (potentiometers).
For further information please click the title in the alert column.
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
KEY
The information displayed
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order of risk (top indicating
highest risk)
Medicines Safety Assurance Tool (MASTER): Jan 2017
Date of Alert Title of Alert Source of Alert
03.01.2017
Class 4 Caution in Use:
Arava 10mg film-
coated tablets
(Leflunomide) Medical
safety alert - GOV.UK
MHRA
03.01.2017 SPC Updates NICE
04.01.2017
Case Study: Over
ordering of fentanyl
patches via repeat
prescriptions
CQC National
Controlled Drugs
Vigilance Sub-Group
05.01.2017
Drug Alert Class 4,
Bayer Plc, Mirena 20
mcg!/24 Hours
Intrauterine Delivery
System
CAS
20.01.2017
Direct-acting antivirals
to treat chronic
hepatitis C: risk of
interaction with vitamin
K antagonists and
changes in INR
MHRA
20.01.2017Apremilast (Otezla ▼):
risk of suicidal thoughts
and behaviour
MHRA
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright ©Midlands and Lancashire CSU
Medicines Safety Assurance Tool (MASTER): Jan 2017
Summary of Alert
Class 4 Caution in Use: Arava 10mg film-coated tablets (Leflunomide)
Sanofi has informed the MHRA that there is an error in the Braille in 1 in 5 cartons of Arava 10mg film-coated
tablets specifically batch numbers: 5JK2A, 5JK3A, 5JK6G and 6EV2A. On affected cartons, the strength of the
product reads ‘20mg’ instead of ‘10mg’ in Braille. The printed text is correct on all packaging.There is a risk to
patients who have compromised eye-sight and who rely solely on Braille to determine their tablet strength.
Packs with the above batch numbers should not be dispensed to patients who rely solely on Braille. We
understand that there is an alternative batch available, batch number 6GL5E, expiry Aug 2019
Further information is available from: https://www.gov.uk/drug-device-alerts/class-4-caution-in-use-arava-
10mg-film-coated-tablets-leflunomide.
SPC Updates (Primary Care)
Revised SPC: ZEPATIER® (elbasvir and grazoprevir) film coated tablets: Section 4.5 now includes advice on the
interaction between Zepatier and vitamin K antagonists – INR should be monitored closely.
Revised SPC: Sustanon® 250, 250mg/ml solution for injection (testosterone propionate, testosterone
phenylpropionate, testosterone isocaproate, testosterone decanoate): Section 4.4 now advises that
testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing
studies and reports of thrombotic events in these patients during testosterone therapy.
Revised SPC: APO-go® (apomorphine) products: SPC has been updated with additional information related to
domperidone usage prior to initiation of treatment, titration and discontinuation, and also on assessment of risk
factors for QT interval prolongation prior to initiation of domperidone and apomorphine.
Case Study for Shared Learning: Over-ordering of fentanyl patches via repeat prescriptions
Patient A had a problem with his fentanyl patches falling off and was
replacing them after1-2 days. This resulted in Patient A over-ordering fentanyl patches via repeat prescriptions.
Even with changing a patch every 2 days, Patient A over a 12 month period was legitimately prescribed a 520 day
supply of fentanyl patches. A teenage friend of Patient A’s son was found dead after ingesting a fentanyl patch.
Patient A’s son had been stealing his father’s patches and had given one to his friend. Patient A had suspected
his son of stealing his fentanyl patches. A full investigation was undertaken and it was noted there were various
points at which the excessive amount of prescribed fentanyl patches could have been picked up: the staff
printing off the repeat scripts; the doctors signing the repeat scripts and the pharmacy staff dispensing the
prescriptions. For further information please click the title in the alert column
Drug Alert Class 4, Bayer Plc, Mirena 20 mcg/24 Hours Intrauterine Delivery System. PL 00010/0547
Bayer plc has informed the MHRA that they have received two complaints globally concerning Mirena inserters
with an insertion tube which is mounted inversely to the handle. This has resulted in inversion of the insertion
depth scale, which may lead to incorrect insertion depth and the possibility of a reduced efficacy or adverse
events. A very small number of Mirena inserters may potentially be affected by this issue. An investigation has
shown that both complaints involve one batch of inserters and Mirena batch TU01BPE has been manufactured
using inserters from the same batch.
Any stock on hand from the above batch should be inspected to ensure that the insertion tube is mounted
correctly. This can be done without opening the blister.
This alert is for pharmacy level communication but patients may ask general practice for advice.
Further information is available from:
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAlert.aspx?AlertID=102565
Direct-acting antivirals to treat chronic hepatitis C: risk of interaction with vitamin K antagonists and changes
in INR. INR should be monitored closely during treatment of chronic hepatitis C with direct-acting antivirals in
patients also receiving vitamin K antagonists (e.g. warfarin), because of possible changes in liver function during
treatment. Direct-acting antivirals for the treatment of chronic hepatitis C infection include: boceprevir
(Victrelis); daclatasvir (Daklinza▼); dasabuvir (Exviera▼); ombitasvir, paritaprevir, ritonavir (Viekirax▼);
sofosbuvir (Sovaldi▼); ledipasvir with sofosbuvir (Harvoni▼); and simeprevir (Olysio▼). Vitamin K antagonists
are used as anticoagulant medicines, and include warfarin and acenocoumarol. Healthcare professionals are
advised to: be aware that changes in liver function due to treatment with direct-acting antivirals for chronic
hepatitis C infection may result in fluctuations of INR values in patients taking vitamin K antagonists. In these
patients, INR should be monitored closely and, if necessary, anticoagulant therapy adjusted. Further
information is available from: https://www.gov.uk/drug-safety-update/direct-acting-antivirals-to-treat-chronic-
hepatitis-c-risk-of-interaction-with-vitamin-k-antagonists-and-changes-in-inr
Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour. There is an increased risk that some
patients may experience psychiatric symptoms with apremilast, including depression and suicidal thoughts. Stop
treatment if patients have new psychiatric symptoms or if existing symptoms worsen. Apremilast (Otezla▼) is a
phosphodiesterase-type-4 inhibitor for the treatment of moderate to severe chronic plaque psoriasis or active
psoriatic arthritis in adults who have not responded to other systemic treatments.
Advice for healthcare professionals:
• apremilast is associated with an increased risk of psychiatric symptoms, including depression, suicidal
thoughts, and suicidal behaviours
• suicidal thoughts and behaviour, including completed suicide, have been reported in patients with or without a
history of depression
• carefully assess the benefits and risks of starting or continuing treatment in patients with a history of
psychiatric symptoms, or in those who are taking other medicines likely to cause psychiatric symptoms
• stop treatment if patients experience new psychiatric symptoms or if existing symptoms get worse
• advise patients to inform a healthcare professional if they notice changes in their mood
Further information is available from: https://www.gov.uk/drug-safety-update/direct-acting-antiviral-
interferon-free-regimens-to-treat-chronic-hepatitis-c-risk-of-hepatitis-b-reactivation.
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
KEY
The information displayed
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highest risk)
Medicines Safety Assurance Tool (MASTER): Dec 2016
Date of Alert Title of Alert Source of Alert
31.12.2016
Spironolactone and
renin-angiotensin
system drugs in heart
failure: risk of
potentially fatal
hyperkalaemia—clarific
ation, December 2016
MHRA
14.12.2016
Drug Alert Class 4
Caution In Use;
Medreich; Amoxicillin
Sugar Free Suspension
250mg/5l And
125mg/5l; Pl
21880/0124 And Pl
21880/0123
CAS
31.12.2016
Cobicistat, ritonavir and
coadministration with a
steroid: risk of systemic
corticosteroid adverse
effects
MHRA
19.12.2016
Central Alerting
System: Influenza
Season 2016/17: Use
Of Antiviral Medicines
CAS
31.12.2016December BNF/BNFC
eNewsletter BNF
31.12.2016 SPC Updates NICE
31.12.2016 SPC Updates NICE
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright ©Midlands and Lancashire CSU
Medicines Safety Assurance Tool (MASTER): Dec 2016
Summary of Alert
Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal
hyperkalaemia—clarification, December 2016
In light of feedback, MHRA has clarified previous communication on this topic and advises concomitant use of
spironolactone /eplerenone with ACEi or ARB increases risk of severe hyperkalaemia, particularly in patients with
marked renal impairment, and should be used with caution.
For further information is published on the MHRA website: https://www.gov.uk/drug-safety-
update/spironolactone-and-renin-angiotensin-system-drugs-in-heart-failure-risk-of-potentially-fatal-
hyperkalaemia-clarification
Drug Alert Class 4 Caution In Use; Medreich; Amoxicillin Sugar Free Suspension 250mg/5l And 125mg/5l; Pl
21880/0124 And Pl 21880/0123
Medreich® has provided handling instructions following several complaints that the child-resistant caps are
difficult to open. The complaints follow the introduction of a new child-resistant cap with a red tamper-evident
ring earlier this year. A very small number of caps have an incompatibility between the cap and the bottle.
Additionally, the new child-resistant caps with a red tamper-evident ring require more pressure to open for the
first time compared to child-resistant caps with an induction seal.
This alert is for pharmacy level communication but patients may ask general practice for advice.
For further information is published on the MHRA website:
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102665
Cobicistat, ritonavir and coadministration with a steroid: risk of systemic corticosteroid adverse effects
Coadministration of a corticosteroid with an HIV-treatment-boosting agent may increase the risk of adrenal
suppression due to a pharmacokinetic interaction.
Advice for healthcare professionals:
• all clinicians who may prescribe or administer steroids to patients with HIV should be aware that concomitant
use of a corticosteroid metabolised by cytochrome P450 3A (CYP3A) and a HIV-treatment-boosting agent may
increase the risk of systemic corticosteroid-related adverse effects
• although these reactions are rarely reported, there is potential for this interaction to occur even with non-
systemically administered steroid formulations, including intranasal, inhaled, and intra-articular routes
• coadministration of a HIV-treatment-boosting agent with a CYP3A-metabolised corticosteroid is not
recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be
monitored for systemic corticosteroid-related reactions
• if coadministration is necessary, use of beclomethasone should be considered where possible—particularly for
long-term use. Beclomethasone is less dependent on CYP3A metabolism and, although the risk of an interaction
leading to adverse corticosteroid effects may not be completely removed, it may be lower
For further information is published on the MHRA website: https://www.gov.uk/drug-safety-update/cobicistat-
ritonavir-and-coadminsitration-with-a-steroid-risk-of-systemic-corticosteroid-adverse-effects
Central Alerting System: Influenza Season 2016/17: Use Of Antiviral Medicines
With surveillance data indicating an increase in influenza cases in the community. GPs and other prescribers
working in primary care may now prescribe antiviral medicines for the prophylaxis and treatment of influenza at
NHS expense.
This is in accordance with NICE guidance, and Schedule 2 to the National Health Service (General Medical
Services Contracts) (Prescription of drugs etc) Regulations 2004), commonly known as the Grey List or Selected
List Scheme (SLS).
Antiviral medicines may be prescribed for patients in "clinical at-risk groups" as well as any who are at risk of
severe illness and/or complications from influenza if not treated.
Information on at risk groups and patients eligible for treatment in primary care at NHS expense with either
oseltamivir (Tamiflu), or zanamivir (Relenza), is available at
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/563029/PHE_guidance_antivir
als_influenza_2016_to_2017_FINAL.pdf
December BNF/BNFC eNewsletter This issue includes new monographs for brivaracetam, elvitegravir,
lumacaftor/ivacaftor, panobinostat and ceritinib, as well as dose changes to metronidazole (for acute ulcerative
gingivitis/acute oral infections), and etoricoxib (for rheumatoid arthritis/ankylosing spondylitis).
For further information:
http://pharmaceuticalpress.cmail20.com/t/ViewEmail/y/7BECD3B3FD06529B/7071F82C996F6C90FCACEB58A03
3025D
SPC updates (Primary care):
Revised SPC: Cardura (doxazosin) preparations SPC now highlights that prostate cancer should be ruled out
before initiating therapy. Priapism has been added as a rare adverse event. Gastrointestinal obstruction has also
been added as a rare adverse effect for the modified release preparations only.
Revised SPC: Certican (everolimus) Tablets SPC now states that everolimus has a narrow therapeutic index
which may require adjustments in dosing to maintain therapeutic response.
Revised SPC: Dantrium (dantrolene) 25mg Capsules Gastrointestinal bleeding, tachycardia, bradycardia and
hepatitis have been added to SPC as adverse drug reactions.
Revised SPC: Edarbi (azilsartan medoxomil) tablets The following wording has been removed from SPC: “caution
should be exercised in hypertensive patients with congestive heart failure as there is no experience of use of
Edarbi in these patients.”
Revised SPCs: Epclusa (sofosbuvir and velpatasvir), Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and ledipasvir)
SPCs updated to highlight that as liver function may change during treatment, close monitoring of INR is
recommended during treatment in patients taking concomitant vitamin K antagonists.
Revised SPC: Intuniv (guanfacine) 1 mg, 2 mg, 3 mg, 4 mg prolonged-release tablets SPC has been updated to
include warning about risk of withdrawal blood pressure, increase/rebound hypertension and heart rate
increase, and in very rare cases, hypertensive encephalopathy upon abrupt discontinuation of guanfacine (based
on a single postmarketing case report).
Revised SPC: Lojuxta (lomitapide mesylate) hard capsules SPC has been updated to include a warning on
dehydration, and to add dehydration, alopecia and myalgia as adverse effects of lomitapide.
Revised SPC: Plavix (clopidogrel) 75mg and 300mg tablets Kounis syndrome, a potentially life-threatening
medical emergency consisting of both a severe allergic reaction and acute coronary syndrome, has been added
to SPC as a very rare adverse effect.
Revised SPC: Tritace (Ramipril) tablets SPC updated to include increased risk of angioedema which has been
reported as an interaction of ACE inhibitors in combination with racecadotril.
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Proposed actions Actions taken Date completed Status
KEY
The information displayed
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highest risk)
KEY
The information displayed
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highest risk)
Medicines Safety Assurance Tool (MASTER): Nov 2016
Date of Alert Title of Alert Source of Alert
16.11.2016
Patient Safety Alert:
Risk of severe harm
and death due to
withdrawing insulin from
pen devices
NHS Improvement
31.11.2016
Alert: Glass shards
found in balloon
gastrostomy tube
balloon ports.
CCG
04.11.2016Brimonidine gel
(Mirvaso): risk of
exacerbation of rosacea
MHRA
07.11.2016
Report suspected side
effects to help make
medicines safer: MHRA
launches social media
campaign
MHRA
31.11.2016BNF November 2016
updateBNF
31.11.2016 SPC Updates NICE
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright ©Midlands and Lancashire CSU
Medicines Safety Assurance Tool (MASTER): Nov 2016
Summary of Alert
Patient Safety Alert: Risk of severe harm and death due to withdrawing insulin from pen devices
This alert warns NHS providers of the risk of severe harm and death if an insulin needle and syringe is used to
administer insulin withdrawn directly from a pen device/replacement cartridge. Providers should ensure staff
have access to appropriate equipment and training.
For further information click link: Patient Safety Alert - Withdrawing insulin from pen devices.pdf
CASE STUDY: (Shared learning)
Alert: Glass shards found in balloon gastrostomy tube balloon ports.
Prescribers: Take care to supply only plastic ampoules of water, for use to inflate the balloon port, in balloon
gastrostomy tubes.
Incidents have been reported by Countess of Chester community dieticians where patients have been given
glass ampoules of water, instead of plastic ampoules, to use to inflate the balloon in their balloon gastrostomy
tubes.
Use of glass ampoules can result in small shards of glass entering the balloon port and breaking it. This has
resulted in tubes falling out, and new ones needing to be inserted
When prescribing for patients with balloon gastrostomy tubes, please ensure that the prescription states:
‘Water for injections’ – 10mls amps plastic B Braun (4 per month)
This may come up on EMIS as Mini-Plasco water for injection.
(This is the typical amount required but see below.)
A balloon gastrostomy feeding tube (sometimes called a button or gastro tube) is a small feeding tube inserted
directly into the stomach so that feed, fluid and medication can be administered without swallowing. Once
inserted, the tube is held in place by a small retention balloon which is inflated with a specified amount of
sterile water. The fluid level needs to be checked periodically by the patient or carer to prevent accidental
removal of the balloon gastrostomy tube. The amount of water required and the checking and replacement
intervals will depend on the exact balloon gastrostomy tube used and will be stated in the product instructions.
Acknowledgment to NHS WEST CHESHIRE CLINICAL COMMISSIONING GROUP.
Brimonidine gel (Mirvaso): risk of exacerbation of rosacea
Brimonidine (Mirvaso) is a topical gel indicated for the symptomatic treatment of facial erythema of rosacea in
adults.
Some patients may have exacerbation or rebound symptoms of rosacea. It is important to initiate treatment
with a small amount of gel and increase the dose gradually, based on tolerability and treatment response.
For further information click link: https://www.gov.uk/drug-safety-update/brimonidine-gel-mirvaso-risk-of-
exacerbation-of-rosacea
Report suspected side effects to help make medicines safer: MHRA launches social media campaign
The Medicines and Healthcare products Regulatory Agency (MHRA) has run a social media campaign to
promote reporting of suspected side effects, as part of an EU-wide awareness week.
At the centre of the campaign was an animation showing the story of a patient who has a suspected adverse
reaction. It shows the medicine being taken, a suspected side effect being experienced, how reports are made
by patients or healthcare professionals to the medicines regulator, and how this benefits future patients.
You Tube video: Reporting suspected side effects makes medicines safer
For further information click link: https://www.gov.uk/government/news/report-suspected-side-effects-to-
help-make-medicines-safer-mhra-launches-social-media-campaign
BNF November 2016 update
This update contains 9 significant changes, and 2 new preparations
For further information click link:
https://www.medicinescomplete.com/mc/bnf/current/whatsnew.htm#news644
SPC updates (Primary care):
Revised SPC: Klaricid (clarithromycin) Paediatric Suspension 125mg and 250mg/5ml (Green)
The SPC has been updated with information on the contraindicated use of clarithromycin with ergot alkaloids,
and with oral midazolam due to interactions. Mania and ventricular fibrillation have also been added as
undesirable effects of unknown frequency.
Revised SPC: Securon (verapamil) SR (Green)
SPC warns drug metabolism is delayed in patients with impaired liver function, potentiating/prolonging effects
of verapamil, thus dose needs to be adjusted with carefully in such patients and low doses given initially. Also
SPC advises tablets should be taken without sucking.
Revised SPC: Abilify (aripiprazole) – all presentations (Amber with ESCA) Section 4.8 has been updated to
include the following adverse effects when used in the paediatric population: weight decreased, blood insulin
increased, arrhythmia, and leukopenia.
Revised SPC: Migramax (acetylsalicylic acid/metoclopramide) 900mg/10mg Powder for Oral Solution (Non-
Formulary) The SPC has been updated to include the addition of “transient increase in blood pressure” as an
undesirable effect of unknown frequency.
Revised SPC: Paramax (paracetamol/metoclopramide) – all products (Non-Formulary) The SPC has been
updated to include the addition of “transient increase in blood pressure” as an undesirable effect of unknown
frequency.
SPC updates (Primary care): continue…
Revised SPC: Triapin (felodipine/ramipril) prolonged release tablets – all products (Non-Formulary) The SPC has
been updated to include an interaction with racecadotril which increases the risk of angioedema when used
with ACE inhibitors such as ramipril.
Revised SPC: Nuvaring (etonogestrel/ethinylestradiol) (Non-Formulary) Information on interactions (INs) with
bosentan as an inducer of cytochrome P450 enzymes has been added. New information has also been added
on CYP3A4 enzyme inhibition and on INs with HIV/HCV protease inhibitors and non-nucleoside reverse
transcriptase inhibitors.
Revised SPC: Lopid (gemfibrozil) capsules (Non-Formulary) Concomitant use with dasabuvir is now
contraindicated. Gemfibrozil increases exposure to dasabuvir which may increase the risk of QT prolongation.
Gemfibrozil inhibits CYP2C8; AUC and Cmax of dasabuvir increased 11 and 2 fold respectively on concomitant
administration.
Revised SPC: Lopid (gemfibrozil) 600 mg film-coated tablet (Non-Formulary )
SPC states that concomitant use of gemfibrozil with dasabuvir is contraindicated; gemfibrozil inhibits CYP2C8
leading to increased exposure of dasabuvir, which can increase the risk of QT prolongation. Information on the
interaction with repaglinide was also updated.
Formulary Reference: http://www.birminghamandsurroundsformulary.nhs.uk/
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Proposed actions Actions taken Date completed Status
KEY
The information displayed
on the left hand side is in
order of risk (top indicating
highest risk)
KEY
The information displayed
on the left hand side is in
order of risk (top indicating
highest risk)
Medicines Safety Assurance Tool (MASTER): Oct 2016
Date of Alert Title of Alert Source of Alert
10/26/2016
Managing diabetes:
patients should not
change their insulin
delivery device without
checking with their
healthcare specialist.
MHRA
10/14/2016
EMA recommends
measures to ensure
safe use of Keppra oral
solution
The European
Medicines Agency
10/3/2016
Etoricoxib (Arcoxia):
revised dose
recommendation for
rheumatoid arthritis and
ankylosing spondylitis
MHRA
10/14/2016
Use of metformin to
treat diabetes now
expanded to patients
with moderately
reduced kidney function
The European
Medicines Agency
10/10/2016
The MHRA have
produced a video for
healthcare
professionals and GPs
on our latest advice
about the risk of
valproate medicine
during pregnanc
MHRA
10/19/2016
Parents of infants and
young children should
not use unlicensed
homeopathic teething
tablets or gels which
are available to buy
online due to the risk of
side effects.
MHRA
10/17/2016
Implantable
cardioverter
defibrillators (ICD) and
cardiac
resynchronisation
therapy devices (CRT-
D) – risk of loss of
therapy due to rapid
battery depletion
LINK:
https://www.gov.uk/drug
-device-
alerts/implantable-
cardioverter-
defibrillators-icd-and-
cardiac-
resynchronisation-
therapy-devices-crt-d-
risk-of-loss-of-therapy-
due-to-rapid-battery-
depletion
MHRA
10/13/2016
Automatic external
defibrillator (AED)
LIFEPAK CR Plus and
LIFEPAK EXPRESS –
risk of failure to deliver
a shock.
MHRA
10/19/2016
Class 2 medicines
recall: Nacrez 75
microgram Film-coated
Tablets (Desogestrel)
PL 00289/1706
MHRA
10/31/2016
The hard copy of the
British National
Formulary for Children
2016-2017
BNFc
10/31/2016October BNF/BNF-C
eNewsletterBNF
10/31/2016 SPC Updates NICE
10/31/2016 SPC Updates NICE
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Copyright ©Midlands and Lancashire CSU
Medicines Safety Assurance Tool (MASTER): Oct 2016
Summary of Alert
Managing diabetes: patients should not change their insulin delivery device without checking with their
healthcare specialist.
If patients are contacted directly by a manufacturer or other organisation to try using a different insulin therapy
system they should first discuss this with their diabetes specialist to avoid risk of hyperglycaemia, hypoglycaemia
or diabetic ketoacidosis.
Healthcare professionals are requested to have systems in place to remind their diabetic patients:
• to use devices that have been recommended or prescribed for them by their diabetes specialist
• not to stop or change their prescribed insulin management regimen without seeking the advice of their
diabetes specialist
• to contact their diabetes specialist if they are invited by a manufacturer to trial a new device e.g. via social
media
For further information click: MDA-2016-020 Final.pdf
EMA recommends measures to ensure safe use of Keppra oral solution
Medicine should only be used with dosing syringe included in the package
Several measures have been put in place to ensure that the correct dosing syringe is used to measure Keppra
oral solution, and thus avoid medication errors. Keppra (levetiracetam) is a medicine used to treat epilepsy in
adults and children.
To avoid medication errors and the risk of overdose, parents and carers are advised that only the syringe
provided with the package should be used to measure the dose of Keppra. The different medicine’s cartons and
labels will be coloured differently and clearly indicate the volume of the bottle, the volume of the dosing syringe,
and the age range of the child that the medicine should be used for:
The package leaflet will also include clearer instructions for parents and carers in order to minimise the risk of
using an incorrect dose. Parents and carers are advised always to discard the syringe once the medicine’s bottle
is empty.
In children, the dose of Keppra depends on the child’s bodyweight and age, and the oral solution is the preferred
formulation for use in children less than 6 years of age. The medicine is available as a 100 mg/ml solution in
either a 150 or 300 ml size bottle, and it comes with a 1, 3 or 10 ml syringe.
Healthcare professionals should follow these recommendations:
• Doctors should ensure that the age-appropriate presentation of Keppra is prescribed.
• Doctors should always prescribe the dose in mg with ml equivalence based on the correct age of the patient.
• Pharmacists should ensure that the appropriate presentation of Keppra is dispensed.
• With every prescription, healthcare professionals should advise the patient and/or caregiver on how to
measure the prescribed dose.
• With every prescription, healthcare professionals should remind patients or caregivers to use only the syringe
included in the medicine’s package. Once the bottle is empty, the syringe should be discarded.Etoricoxib (Arcoxia): revised dose recommendation for rheumatoid arthritis and ankylosing spondylitis
Prescribing information has been updated to introduce a lower recommended dose of 60 mg daily for patients
with rheumatoid arthritis or ankylosing spondylitis.
Advise for healthcare professionals:
• The cardiovascular and other important risks of etoricoxib (Arcoxia) may increase with dose and duration of
exposure. Therefore, the lowest effective daily dose should be used, and the need for treatment should be
regularly reassessed
• the recommended dose is 60 mg once daily
• in patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may improve efficacy
• once the patient is clinically stabilised, down-titration to 60 mg once daily may be appropriate
• in the absence of therapeutic benefit, other treatment options should be considered
For further information click: https://www.gov.uk/drug-safety-update/etoricoxib-arcoxia-revised-dose-
Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
Recommendations for patients with kidney impairment updated in product information
The European Medicines Agency (EMA) has concluded that metformin-containing medicines can now be used in
patients with moderately reduced kidney function (GFR [glomerular filtration rate]=30–59 ml/min) for the
treatment of type 2 diabetes. The product information for these medicines will be updated to revise the current
contraindication and give information about doses, monitoring and precautions in patients with reduced kidney
function.
The recommendations are the result of a review by EMA of metformin-containing medicines following concerns
that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney
function. The current product information also varies between countries and products in the EU and is no longer
consistent with clinical guidelines.
Metformin may increase the risk of a rare but serious complication called lactic acidosis, which occurs when
naturally produced lactic acid builds up in the blood faster than it can be removed. Currently, the product
information states that metformin must not be used in patients with reduced kidney function because these
patients are considered to be at a higher risk of developing lactic acidosis as their kidneys do not remove
metformin efficiently enough.
However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines
from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function
can benefit from use of metformin. Clear dosing recommendations and monitoring before and during treatment
aim to minimise any possible increased risk in these patients. The contraindication for patients with severely
reduced kidney function will remain (GFR less than 30 ml/min).
For further information click:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/10/news_detail_002620.j
sp&mid=WC0b01ac058004d5c1 Discussing Valproate
The MHRA have produced a video for healthcare professionals and GPs on our latest advice about the risk of
valproate medicine during pregnancy. The MHRA toolkit also includes booklets, a checklist, and a patient
information card.
The video can be found here (open link in chrome) https://www.youtube.com/watch?v=KxczXWCjOTk and here:
https://www.facebook.com/mhragovuk/videos/1149193091785165/
Clinicians in your networks reviewing people taking valproate may find it helpful.
Parents of infants and young children should not use unlicensed homeopathic teething tablets or gels which are
available to buy online due to the risk of side effects.
MHRA are warning all Parents of infants and young children that they should not use unlicensed homeopathic
teething tablets or gels which are available to buy online due to the risk of side effects.
This advice follows a US Food and Drug Administration (FDA) investigation into homeopathic teething tablets
and gels which could cause serious side effects such as seizures, difficulty breathing, lethargy, excessive
sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation.
These particular products are made and supplied by manufacturers in the USA and are not licensed for use in the
UK and are not known to be available in UK outlets. However the unlicensed products may be advertised on
online shopping or pharmacy websites.
For further information click: https://www.gov.uk/government/news/parents-advised-not-to-use-unlicensed-
homeopathic-teething-products-in-infants-and-children
Medical Device Alert
Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) – risk of loss
of therapy due to rapid battery depletion
Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device
failure and loss of therapy.
This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek
advice about the contents of this notice.
GPs need take no further action on receipt of this alert – For your information only
Medical Device Alert
Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS – risk of failure to deliver a shock.
Manufactured by Physio-Control – risk of delay to defibrillation due to an intermittent component failure.
Specific serial numbers are affected. See link for further details
https://www.cas.dh.gov.uk/ViewAndAcknowledgment/viewAttachment.aspx?Attachment_id=102622
DRUG RECALLS
Class 2 medicines recall: Nacrez 75 microgram Film-coated Tablets (Desogestrel) PL 00289/1706
Teva UK Limited is recalling the above batches because out of specification results for impurities were obtained
during routine stability testing. No complaints relating to this issue have been received by the company to date.
Women currently using this product are advised to finish the pack and if they have any concerns they should
speak to their doctor or pharmacist.
Remaining stock of these batches should be quarantined and returned to the original supplier for credit.For
stock enquiries, please contact Teva UK Limited Customer Service on 0800 590 502.For medical information
enquiries please contact Teva UK Limited by phone on 0207 5407117 or by email to [email protected].
GPs need take no further action on receipt of this alert – For your information only
The hard copy of the British National Formulary for Children 2016-2017
The hard copy of the British National Formulary for Children 2016-2017 has been updated and published.
Electronic versions are updated monthly.
Significant changes in this revision are highlighted in this link:
https://www.medicinescomplete.com/mc/bnfc/current/PHP107699-changes.htm
October BNF/BNF-C eNewsletter This month's issue includes notifications of new drug monographs for tedizolid,
brinzolamide with brimonidine, and rilpivirine, as well as updated NICE guidance on treatment of Alzheimer's
disease, and on azacitidine for acute myeloid leukaemia.
Revised SPCs: Adalat, Adalat 5, Adalat retard 10mg and 20mg modified-release tablets (nifedipine) The SPCs
have been updated with information on the use of nifedipine in patients with hepatic impairment. Nifedipine
should be used with caution in severe hepatic impairment. Careful monitoring and dose reduction may be
required with any severity of liver impairment.
Revised SPCs: Aldomet (methyldopa) 250mg and 500mg tablets Angioedema and urticaria have been added as
undesirable effects of methyldopa with unknown frequency.
Revised SPC: E45 Cream Patients using large quantities (>100g) of paraffin (PF) product are advised to regularly
change clothing/bedding/dressings impregnated with it and keep away from naked flames as there is a fire
hazard. Also absorption of topical minoxidil can be increased with topical soft PF.
Revised SPC: Iressa (gefitinib) 250mg film-coated tablets Allergic reactions including angioedema and urticarial
are now listed as common undesirable effects. The SPC has also been updated with information regarding a
causal association between QT prolongation and gefitinib.
Revised SPC: Lenvima (lenvatinib) 4mg and 10mg hard capsules Arterial thromboembolism has been added to
SPC as a serious adverse reaction and section 4.4 has been updated to include special warnings/precautions on
non-gastrointestinal fistula and diarrhoea.
Revised SPC: Sovaldi (sofosbuvir) tablets Bradyarrhythmia when used with another direct-acting antiviral and
amiodarone has been added as a caution. Life threatening cases have been reported and amiodarone should
only be used when other alternative anti-arrhythmic treatments are not tolerated or contraindicated.
Revised SPC: Tracleer (bosentan) 62.5 mg and 125mg film-coated tablets
SPC states patients should be advised not to swallow desiccant found in white high-density polyethylene bottles,
and mentions risk of blurred vision which could affect ability to drive/use machines. Tablets in above-mentioned
bottles should be used within 30 days after opening.
Please note that the information in this Safety log is correct at the time of publication. Clinicians should always refer to the most up to date information
Proposed actions Actions taken Date completed Status
KEY
The information displayed
on the left hand side is in
order of risk (top indicating
highest risk)