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

gMedicineSafely/MedicationHealthFraud/ucm365991.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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