FDA’s Warning on “Ortiga”
P. Naina MohamedPharmacologist
Introduction On 22nd Aug 2013, the Food and Drug Administration (FDA) is
advising consumers not to purchase or use Ortiga, which is an unapproved product.
Ortiga is sold on multiple websites, including www.ebay.com, and in some retail stores.
Ortiga is manufactured in Mexico and labeled primarily in Spanish.
Ortiga contains the prescription drug ingredient, diclofenac and was confirmed by FDA laboratory analysis.
Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs) which may increase the risks of heart attack, stroke, gastrointestinal bleeding, ulceration, and fatal perforation of the stomach and intestines.
Diclofenac may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
Cardiovascular risksOrtiga
Contains undeclared Diclofenac
Cyclooxygenase 2 inhibition
Inhibit the synthesis of prostacylin (PGI2) in endothelial cells
Reduced restriction on prothrombotic and atherogenic stimuli by PGI 2
Increased risk of thrombosis
Elevated risk of Myocardial infarction and Stroke
Gastro intestinal DamageOrtiga
Contains undeclared Diclofenac
Block Cyclooxygenase 1 (COX 1) enzyme
Inhibition of PGE2 synthesis
Reduced mucous secretion and bicarbonate secretion
Damage of Gastro intestinal mucosa
Gastro intestinal ulceration
GI Hemorrhage, perforation
Life-threatening bleeding (Acute) and Anemia (Chronic)
Hypersensitivity reactions (Pseudoallergic reactions)
Ortiga
Contains undeclared Diclofenac
Block Cyclooxygenase 1 (COX 1) enzyme
Inhibit synthesis of PGE2 in lungs
Relieving of Inhibitory effects of PGE2 on production of Cysteinyl-Leukotrienes
Elevated levels of Cysteinyl-Leukotrienes
Bronchoconstriction , Rhinosinusitis
Bronchospasm and/or Laryngospasm, Rhinorrhea, and Nasal congestion
Hypersensitivity reactions (Pseudoallergic reactions)
Ortiga
Contains undeclared Diclofenac
Block Cyclooxygenase 1 (COX 1) enzyme
Inhibit synthesis of Constitutive PGs
Acute urticaria and/or angioedema (skin, lips, and mouth)
Hypersensitivity reactions (Allergic reactions)
Ortiga
Contains undeclared Diclofenac
IgE mediated reaction
Allergic reactions (Urticaria, Angioedema or Anaphylaxis)
Risk of HemorrhageOrtiga
Contains undeclared Diclofenac
Blockade of COX 1 of platelets
Reduced Thromboxane A2 (TXA 2) synthesis
Decreased Platelet aggregation
Increased risk of Bleeding
Early Closure of Ductus Arteriosus (DA)
Ortiga
Contains undeclared Diclofenac
Blockade of COX enzyme
Inhibition of Synthesis of Prostaglandins
Early closure of Ductus arteriosus(During last trimester of pregnancy)
Fetal blood flows in to lungs
Respiratory failure, impaired right ventricular function, tricuspid regurgitation and right heart dilatation
Renal IschemiaOrtiga
Contains undeclared Diclofenac
Blockade of COX 2 enzyme of renal cells(In patients with CHF, CKD, etc)
Inhibition of synthesis of Vasodilator Prostaglandins (PGE 2 and PGI 2)
Reduction of renal blood vessel dilation and blood flow
Renal ischemia
Risk of EdemaOrtiga
Contains undeclared Diclofenac
Blockade of COX 2 enzyme of renal cells(In patients with CHF, CKD, etc)
Inhibition of synthesis of Prostaglandins
Reduction of inhibitory effect of PGs on Cl– reabsorption and ADH activity
Fluid retention
Edema and Hypertensive complications
Contraindications
Ortiga (Diclofenac) is contraindicated in the following conditions due to its adverse effects on the systems…
1. Active gastric or duodenal ulcer
2. Bronchial Asthma
3. Third trimester of pregnancy
Drug InteractionsOrtiga (Diclofenac) +
Warfarin, Apixaban, Rivaroxaban, Enoxaparin, Dalteparin, Aredeparin, Tinazaparin, Ibritumomab, Tositumomab,
Cabozantinib, Ponatinib, Regoratinib, Prasugrel, Anisindione, Fondaparinux or Desirudin
Increased risk of Bleeding(Due to the inhibition of platelet aggregation by NSAIDs)
Unusual bleeding or bruising, swelling, vomiting, blood in your urine or stools, headache, dizziness, or weakness
Drug InteractionsOrtiga (Diclofenac) +
Leflunomide, Teriflunomide or Lomitapide
Excessive levels of Liver enzymes like ALT & AST
Increased risk of (Liver Damage) Hepatotoxicity
Fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, light colored
stools, and/or yellowing of the skin or eyes
Drug InteractionsOrtiga (Diclofenac) +
Adefovir, Cidofovir, Tenofovir, Tacrolimus, Sirolimus, Sodium Biphosphate or IV
Immunoglobulins
Increased risk of kidney damage
Increased or decreased urination, sudden weight gain or weight loss, fluid retention, swelling, shortness of
breath, muscle cramps, tiredness, weakness, dizziness, confusion, and irregular heart rhythm.
Drug Interactions
Ortiga (Diclofenac) +ACE inhibitors
Increased risk of Hyperkalemia
Bradycardia
Syncope in Elderly and cardiac patients
Drug Interactions
Ortiga (Diclofenac) +Corticosteroids or SSRIs
Increased GI complications
Conclusion Consumers should stop using Ortiga immediately and dispose of it. Consumers should consult a health care professional as soon as
possible if they have experienced any negative side effects, such as unusually dark stools or urine, stomach pain, increased bruising, or other signs of bleeding.
The purpose of this notification is to inform the public of a growing trend of dietary supplements or conventional foods containing hidden drugs and chemicals.
These products are typically promoted to unsuspecting customers for sexual enhancement, weight loss, and body building, or for other medical uses and are often represented as being “all natural.”
FDA is unable to identify and test all such products that may have potentially harmful hidden ingredients.
Consumers should exercise caution before purchasing any product in the above categories.
References http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsin
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