February 15, 2012
Counterfeit Cancer Drug Circulating Throughout The US
Roche Genentech is warning doctors and patients that counterfeit vials of its cancer drug Avastin have been distributed in the U.S.
The fake drugs do not contain the key ingredient in Avastin, which is used to help treat cancers of the colon, lung, kidney and brain.
A spokeswoman for Roche Genentech said the counterfeit drug has been distributed to health care facilities in the U.S., but it´s unclear how many vials are in circulation in the U.S.
The company said it is working with the Food and Drug Administration (FDA) 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," Genentech spokeswoman Charlotte Arnold said in a press release. "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 counterfeit vials do not have "Genentech" printed on their packing, which appears on all the original packing of the drug.
Also, the original Avastin contains a six-digit lot number with no letters, and all the packaging text should be in English.
The FDA said on Tuesday that it has contacted 19 medical practices that may have purchased the unapproved drugs from a company called Quality Specialty Products.
The agency said the foreign supply company may also do business as Montana Health Care Solutions.
"FDA has requested that the medical practices stop using any remaining products from these suppliers," the agency said in a statement.
Foreign health regulators alerted Genentech to the problem originally, and officials believe the counterfeits were imported from another country.
The original Avastin drug is packaged in manufacturing facilities in South San Francisco, California.
Avastin works by choking off blood supply that feeds tumors, and it was the first drug of its kind approved by the FDA.
Data tracking firm IMS Health said that the drug was the 14th best-selling drug in the U.S. in 2010.
This is not the first time counterfeit drugs have made their way into doctors´ hands in the U.S. A contaminated blood thinner called heparin was connected with dozens of deaths and hundreds of allergic reactions across the U.S. in 2008.
An FDA investigation concluded the drug had been intentionally contaminated with an ingredient that mimics heparin. The drug was imported from China.
About 80 percent of active ingredients used in U.S. prescription drugs are now manufactured overseas, according to congressional investigators.
Recent legislation could give FDA the authority to inspect foreign drug imports. A separate legislation would create a mandatory barcode system to monitor the authenticity of all prescription drugs.
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