The FDA released a statement on February 14, 2012, warning pharmacies, medical practices, and patients that a counterfeit version of the drug Avastin—an injectable drug used to treat cancer of the colon, lung, kidney, and brain—has been purchased and used by some medical practices in the United States.
According to an FDA statement
, 19 medical practices purchased the unapproved versions from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions.
The counterfeit version is labeled as Avastin and has a Roche logo on the packaging, whereas the FDA-approved drug in the United States does not include the Roche logo and has “Genentech” printed on the packaging. Roche is the company that manufactures Avastin approved for marketing outside of the country, but this version is not approved by the FDA for use within the United States.
Packages and vials of Avastin displaying batch numbers that start with B6010, B6011, or B86017 may also be counterfeit, the FDA warned.
Roche conducted laboratory tests that confirmed the counterfeit version of Avastin, and verified that the material they tested did not contain Avastin’s active ingredient, bevacizumab.
The alert from the FDA Safety Information and Adverse Event Reporting Program recommended that medical practices that obtained products from QSP or from their distributor, Volunteer Distribution, should stop using the products, retain and securely store the remaining medication, and call or email the FDA’s Office of Criminal Investigations.
Health care professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.