FDA Warns About Fraudulent Tamiflu

/USNewswire/ -- The U.S. Food and Drug Administration today 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 active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they 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.

"A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient."

The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder (see photos below). The foil backing is printed, and labeled in part, "Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules" and "Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD."

Although the FDA actively monitors the Internet and when appropriate purchases and analyzes drug products, consumers who purchase drugs using an online pharmacy can protect themselves by knowing how to recognize a legitimate Internet pharmacy and how to buy medicines safely online. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations.

Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info

The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by calling 800-551-3989, or by visiting the OCI website (http://www.fda.gov/OCI).

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these fraudulent products to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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FDA Warns Public of Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. No medications are ever delivered. A subsequent call is received from a fraudulent "FDA special agent" informing the consumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business."

Consumers should note that the fraudulent calls appear to be from telephone numbers located within the United States, but are in fact from either ported voice-over-the-Internet-protocol numbers (calls made directly from a computer and moved or "ported" to other computers to avoid detection) or cellular phones. Reports to FDA describe the callers as having Hispanic accents.

The scheme most likely began with the theft of personal information from consumers who previously purchased drugs via the Internet or telephone or who were victims of credit card fraud.

The FDA is investigating and complaints or information regarding this scheme should be reported to the FDA Office of Criminal Investigations at (800) 521-5783.

The FDA reminds consumers to purchase prescription drugs only from licensed pharmacies located in the United States. Information about the proper purchase of on-line medicine can be found at: http://www.fda.gov/consumer/features/drugsonline0707.html.

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