(AP) The maker of the widely prescribed cancer drug Avastin is warning doctors and patients about counterfeit vials of the product that have been distributed in the U.S.
Roche’s Genentech unit said Tuesday that the fake products do not contain the key ingredient in Avastin, which is used to treat cancers of the colon, lung, kidney and brain. The drug is a huge money-maker for Roche, generating about $6 billion a year.
A spokeswoman said the counterfeit drug has been distributed to health care facilities in the U.S., though it’s unclear how many vials are in circulation or where they may be concentrated. The company is working with the Food and Drug Administration to track down the counterfeit vials and analyze their contents.
“We’re still analyzing what it is, we know it doesn’t contain the active ingredient in Avastin,” said Genentech spokeswoman Charlotte Arnold.
Avastin is administered in doctor’s offices and hospitals.
“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,” Arnold said.
This undated photo provided by Genetech shows a counterfeit vial of the cancer drug Avastin. The maker of the best-selling cancer drug Avastin is warning doctors and patients about counterfeit vials
The counterfeit products do not have “Genentech” printed on their packaging, which appears on all FDA-approved cartons and vials of the drug. Additionally, legitimate Avastin contains a six-digit lot number with no letters. All the packaging text should be in English.
The company believes drugs labeled with the following lot numbers may be fake: B86017, B6011 and B6010.
In a related action, the FDA said late Tuesday it has contacted 19 medical practices that may have purchased unapproved drugs, including counterfeit Avastin, from a company called Quality Specialty Products. The foreign supply company may also do business as Montana Health Care Solutions, the agency said.
Avastin works by choking off the blood supply that feeds tumors. It was the first drug of its kind approved by the FDA.
~ Many have gone months using the counterfeit which does not help at all.
Dr. Siegel weighs in on counterfeit medications:
Drug contamination and counterfeiting has become a growing concern for U.S. pharmaceutical companies as they have increasingly moved operations offshore. About 80 percent of the active ingredients used in U.S. prescription drugs are now manufactured overseas, according to congressional investigators.