FDA issues warning about 'dangerous' fake Tamiflu

A product sold over the Internet as 'Generic Tamiflu' has been found to contain an antibiotic that poses a serious and potentially life-threatening risk to people who are allergic to penicillin products, according to the US Food and Drug Administration (FDA).

The case reveals once again the flagrant disregard of those involved in the counterfeiting of medicines for the safety of those who may end up taking their products.

The FDA purchased Generic Tamiflu over the Internet without a prescription and upon analysis discovered that the product did not contain oseltamivir - the ingredient found in Roche's genuine Tamiflu product - but cloxacillin.

"Patients who are allergic to penicillin products are at risk of experiencing similar reactions from cloxacillin," says the agency in its MedWatch alert.

"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."

Although the website which sold the Generic Tamiflu product to the FDA operatives is no longer operational, the agency believes the product is likely to be found for sale through other websites. There is no generic version of Tamiflu approved for sale in the USA.

A Google search at the time of writing revealed several sites offering Generic Tamiflu and similar products without a prescription. 

In this case, the product was supplied in two foil-backed blister packages labelled with "Oseltamivir Phosphate 75 mg. Capsules TM-FLU" and containing 15 yellow and tan capsules each filled with white powder.

And sometimes there are clear clues about a lack of authenticity in the name: in this case the fraudulent pills are manufactured by TRYDRUGS Pharmaceuticals, said the FDA.

The agency advises consumers to make sure they only purchase medicines online through sites bearing the Verified Internet Pharmacy Sites (VIPPS) seal, a scheme operated by the National Association of Boards of Pharmacy. A list of legitimate online pharmacies can be found at www.vipps.info.

Critics of these certification schemes, however, point out that many consumers will not know how to check for the VIPPS seal. Some also argue that such seals can themselves be faked and could lull the consumer into believing that a rogue pharmacy is in fact legitimate. 

Last month, a website in Europe was found to be sporting a similar accreditation seal operated by the PGEU, raising questions about the value of plans in the EU to introduce a community-wide accreditation and logo scheme for online pharmacies.