Thursday, April 26, 2018

Roche warns of counterfeit cancer drug in U.S.

WASHINGTON — 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 United States.

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 moneymaker for Roche, generating about $6 billion a year.

A spokeswoman said the counterfeit drug has been distributed to health care facilities in the United States, 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.

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 thinks 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.

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