Case 1 ADR

7/30/2019 Case 1 ADR

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Gabrito, Christian John N.

5CLPH

Case 1:

A 7 year old female came to the emergency room with a chief complaint of fever. Patient was

diagnosed with leukemia (Acute Myelogenous Leukemia) currently on remission. She discontinued

hydroxyurea and now is only on Vit. B - complex. In the ER other than fever patient hasn’t been

defecating for the past 3 days. The 2nd

year pediatric care resident ordered fleet enema. The scout film of

the abdomen of the patient has pre-sacral gas. The nurse administered fleet enema, 5 mins. Later thepatient is on convulsion described as general tonic clonic seizures. Patient was given diazepam 0.3

mg/kg (Patient’s weight was 25kg) given per rectum. Patient was sent to the CT -scan for a brain scan

which turned out to be cerebral edema. Patient was admitted at PICU, 3 days later the patient died.

Patient was signed out as cerebral edema probably due to CNS infection, AML and febrile neutropenia.

Guide Questions:

1. What are the possible causes of the seizure of the patient?

Benign febrile seizures - Most common seizure disorder of childhood with fever greater than100°F (>38°C), although 75% occur at temperatures greater than 102°F (>39°C); usually occurson the first day that fever is present. It usually occurs in children from 6 months to 5 years old(although some extend the range from 3 months to 7 years).

Adverse Drug Reaction of hydroxyurea - The treatment of human erythrocytes with hydroxyurea

results in the azide-dependent changes in osmotic fragility and in increased methemoglobin

formation. Thus, it can lower your white blood cell count, especially a few days after the drug is

given. This can increase your chance of getting an infection. Signs of infection, such as fever

(100.5° or higher), chills, pain when passing urine, a new cough, or bringing up sputum are to be

monitored. As a rare ADR brain effects like dizziness, confusion, hallucinations and seizures can

happen.

No antibiotics were prescribed to the patient – It is evident that treatment with anti-metabolites

like hydroxyurea can cause the patient to be immuno-compromised resulting to infection which

may have caused the cerebral edema of the patient and ultimately seizures and death.

Adverse Drug Reaction of fleet enema – as a serious adverse drug effect it can cause tonic-clonic

seizures and electrolyte imbalance

2. Was there an ADR?

Yes, the most probable cause is the fleet enema having a Naranjo Score of 2 and the adverse

drug reaction of having seizures was seen 5 mins. after it was administered. Normally this

reaction wouldn’t happen to fleet enema since it only acts locally on the GIT to evacuate its

content. But, the patient has a complicated case since she has leukemia and is immuno-

compromised. Fleet enema being ionic in nature was absorbed in the brittle blood vessels of the

gastrointestinal walls and reached the CNS. Exerting its osmotic effect it caused cerebral edema

by intracellular swelling of the neurons leading to seizures. It could have been prevented if the

patient was prescribed with a surfactant type of enema like soap suds which is a larger molecule

and won’t be easily absorbed.

7/30/2019 Case 1 ADR



5CLPH

3. What tool will determine probability of ADR?

The Naranjo algorithm, Naranjo Scale, or Naranjo Nomogram is a questionnaire designed by

Naranjo et al. for determining the likelihood of whether an ADR (adverse drug reaction) is actually due to

the drug rather than the result of other factors. Probability is assigned via a score termed definite,

probable, possible or doubtful. Values obtained from this algorithm are sometimes used in peer reviews to

verify the validity of author's conclusions regarding adverse drug reactions. It is also called the Naranjo

Scale or Naranjo Score.

Questionaire:

1. Are there previous conclusive reports on this reaction?

Yes (+1) No (0) Do not know or not done (0)

2. Did the adverse events appear after the suspected drug was given?

Yes (+2) No (-1) Do not know or not done (0)

3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?


4. Did the adverse reaction appear when the drug was readministered?

Yes (+2) No (-1) Do not know or not done (0)

5. Are there alternative causes that could have caused the reaction?

Yes (-1) No (+2) Do not know or not done (0)

6. Did the reaction reappear when a placebo was given?

Yes (-1) No (+1) Do not know or not done (0)

7. Was the drug detected in any body fluid in toxic concentrations?


8. Was the reaction more severe when the dose was increased, or less severe when the dose was

decreased?


9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure?


10. Was the adverse event confirmed by any objective evidence?


http://en.wikipedia.org/wiki/Adverse_drug_reaction

http://en.wikipedia.org/wiki/Drug

http://en.wikipedia.org/wiki/Drug

http://en.wikipedia.org/wiki/Adverse_drug_reaction

7/30/2019 Case 1 ADR



5CLPH

Scoring

> 9 = definite ADR

5-8 = probable ADR

1-4 = possible ADR

0 = doubtful ADR

4. How will you communicate to the relatives that there was an ADR?

I will talk to the relatives in a very calm way and tell them objectively what the situation was and what

happened. First, I will tell them the drug that was in question for having the adverse drug reaction, how it

was supposed to work, and how it manifested in the patient. Then, I will tell them that this was an

unexpected event that nobody could have predicted and that everyone in the healthcare team is doing

what they can to sort this thing out.

5. How will you motivate an attending physician to report an ADR?

To encourage/motivate more physicians to report ADR, the forms must be made easier to complete,undertake information campaigns on how to monitor the signs and symptoms of an ADR, create anincentive system to those who will report ADRs and create a campaign promoting saving lives, which for every ADR reported numerous lives would be saved by having these reports as reference to preventthese cases from ever happening again.

Sources:

https://www.clinicalkey.com/topics/pediatrics/febrile-seizures.html

http://www.cancer.org/treatment/treatmentsandsideeffects/guidetocancerdrugs/hydroxyurea

http://www.ncbi.nlm.nih.gov/pubmed/6732772

http://en.wikipedia.org/wiki/Naranjo_algorithm













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Case 1 ADR