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.
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.
"FDA has requested that the medical practices stop using any remaining products from these suppliers," the FDA said in a statement. Genentech said the suppliers listed by the FDA are not authorized to distribute Avastin.
Genentech was alerted to the problem by foreign health regulators and company officials believe the counterfeits were imported from abroad, though they could not specify which country. Genentech packages Avastin at U.S.-based manufacturing facilities and is based in South San Francisco. Its parent company, Roche Holding AG, is based in Basel, Switzerland.
Doctors who suspect they have received counterfeit drug should contact the FDA's criminal unit or Roche's quality assurance department.
Avastin works by choking off the blood supply that feeds tumors. It was the first drug of its kind approved by the FDA.
The injectable drug was the 14th best-selling drug in the U.S. in 2010, according to data tracking firm IMS Health.
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.
In 2008, a contaminated blood thinner called heparin was connected with dozens of deaths and hundreds of allergic reactions across the U.S. after being imported from China. An FDA investigation concluded the drug had been intentionally contaminated with an ingredient that mimics heparin "to reduce the costs of production."
Recent legislation introduced in the House would give the FDA greater resources and authority to inspect foreign drug imports. Separate legislation would create a mandatory barcode system to monitor the authenticity of all prescription drugs moving through the U.S. supply chain.
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