Counterfeit Avastin was just discovered at U.S. health care facilities, prompting the maker of the cancer drug to warn doctors and patients about the bogus medications.
According to Roche’s Genentech, the fake Avastin does not contain the key ingredient in Avastin, which is prescribed for the treatment of colon, lung, kidney, and brain cancers, said The Associated Press (AP).
A Genentech spokeswoman said the counterfeit drug was distributed to health care facilities nationwide; however, the exact number of counterfeit products that were released, and where those products were sent, remains unknown. The firm and the U.S. Food and Drug Administration (FDA) are collaborating to locate bogus vials and determine their contents, said the AP.
“We’re still analyzing what it is; we know it doesn’t contain the active ingredient in Avastin,” Genentech spokeswoman Charlotte Arnold told the AP. Arnold also noted that Genentech learned of the problem from foreign health regulators and believes the counterfeits were likely imported; however, she could not say which country is involved, said the AP.
The AP wrote that the counterfeit products do not bear “Genentech” on their packaging, which does appear on all FDA-approved Avastin cartons and vials. The legitimate Avastin product contains a six-digit lot number with no letters and legitimate product packaging text is in English. Genentech believes that the bogus drugs may bear the following fake lot numbers: B86017, B6011, and B6010, said the AP.
Meanwhile, the FDA indicated that it contacted 19 medical practices that may have bought some unapproved drugs, including counterfeit Avastin, from Quality Specialty Products, a foreign supply company that may also be conducting business as Montana Health Care Solutions, the AP said. “FDA has requested that the medical practices stop using any remaining products from these suppliers,” the FDA said in a statement.
The AP said that physicians who believe they may be in possession of the counterfeit Avastin should contact the FDA’s criminal unit or Roche’s quality assurance department.
We recently wrote that as expected, the FDA revoked its approval of Avastin as a treatment for breast cancer. In doing so, the FDA concluded that Avastin was not a safe or effective treatment for breast cancer. Avastin will remain on the market as a treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme). Doctors could continue to use Avastin off-label for breast cancer, but insurance companies will likely stop paying for Avastin for this use. Treatment with Avastin costs about $88,000 a year.
Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program. But two studies conducted by the drug’s maker, Genentech, later showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone; not enough to outweigh the risk of taking the drug, the FDA said.