FDA warns of counterfeit Tamiflu product

The FDA has warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's (from Roche) active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. Patients who are allergic to or may have experienced adverse reactions from penicillin products are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions. There is no FDA-approved generic drug for the prescription product Tamiflu.

The FDA bought the fraudulent "Generic Tamiflu" without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however. The counterfeit Tamiflu products purchased by the FDA arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder. The foil backing is printed, and labeled in part, "Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules" and "Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD."

Pictures of the counterfeit product can be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216148.htm.

Consumers who believe they have counterfeit Tamiflu in their possession should stop using the product immediately and contact their healthcare provider if any adverse events occur that may be related to the use of the product.

Tamiflu is indicated for the treatment of uncomplicated acute illness due to influenza in patients ≥1 year of age who have been symptomatic for ≤2 days and prophylaxis of influenza in patients ≥1 year of age.