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Posted Feb 15, 2012, 5:14 pm
Counterfeits of Avastin, Swiss drug maker Roche's multi-billion dollar cancer drug, are circulating in the United States, the company warned on Tuesday.
Reuters reported that Roche was contacted about the fake Avastin by a health authority outside the United States, but it does not yet know how much of the counterfeit drug is out in the market.
"We are working with the FDA and law enforcement to aid their evaluations, determine the source of the counterfeit drug, and prevent its further distribution," Roche and Genentech said in a statement. "The counterfeit product is not safe or effective and should not be used."
Roche's U.S. biotech wing Genentech said that the fake products do not contain the key ingredient in Avastin, which is given intravenously and used to treat colon, lung, kidney and brain cancers, the Associated Press reported. The drug generates about $6 billion a year for Roche.
"We're still analyzing what it is, but we know it doesn't contain the active ingredient in Avastin," Genentech spokeswoman Charlotte Arnold told the AP. "It's an infused medicine and not something a patient would have in their hands, so it's really health care providers who should be on the lookout."
The unapproved cancer medications were purchased from a foreign supplier known as Quality Specialty Products, which may also be known as Montana Health Care Solutions, according to the FDA, CNN reported. The Food and Drug Administration has contacted 19 medical practices that may have purchased unapproved drugs, including counterfeit Avastin, from the company, the AP reported.
Patients and doctors can tell the counterfeit drugs from the real ones by their labels: real Avastin has Genentech on the label, which is all in English, and the counterfeit labels say "Roche" and are in French, according to Reuters. As well, lot numbers of actual Avastin have six digits with no letters, while the counterfeit lot numbers begin with a letter.
Avastin is administered in doctor's offices and hospitals, and works by choking off the blood supply that feeds tumors, according to the AP. It was the first drug of its kind approved by the FDA.