FDA Warns of Fradulent Generic Tamiflu

The FDA is warning consumers that illegal internet pharmacies are selling fake Tamiflu, which could be dangerous to users’ health. 

An FDA alert was issued on June 17 about fraudulent Tamiflu being sold as “generic” Tamiflu on internet websites. The fake drugs do not contain the active ingredient in Tamiflu, oseltamivir. Instead, the ones purchased by FDA investigators actually contained cloxacillin, which is in the same class of antibiotics as penicillin.

The FDA is concerned that consumers with allergies to penicillin-based antibiotics could be injured by fraudulent generic Tamiflu, which does not warn that it contains cloxacillin. Reactions due to cloxacillin or penicillin allergies include a life-threatening condition known as anaphylaxis, which can involve symptoms including difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness or rapid or weak pulse.

Tamiflu (oseltamivir) was approved in the United States by the FDA in 1999 for the treatment and prevention of influenza. It is an orally active neuraminidase inhibitor that works by slowing the spread of the flu virus between cells in the body. Tamiflu has been heavily circulated for the treatment of H1N1 flu virus, also known as Swing Flu.

FDA drug safety inspectors purchased the generic Tamiflu from an internet website that claimed to be an online drug store. The website no longer appears to exist, FDA officials said. The drugs the agency received were shipped from India and are labeled “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” but they contain no oseltamivir. The foil backing says that the pills were “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.”

Despite the disappearance of the original website, FDA warns that other illegal online pharmacies may be selling fake generic Tamiflu as well. The FDA has never approved a generic version for Tamiflu, so all drugs claiming to be a generic version of the drugs are fake and should be avoided, the agency warns.