The U.S. Food & Drug Administration (FDA) has issued a warning stating that a counterfeit version of Genetech’s widely-used cancer drug Avastin may have been purchased by a number of medical practices in the United States. The counterfeit version does not contain the drug’s active ingredient, bevacizumab, which may have resulted in patients suffering serious complications. Since first being approved in 2004, Avastin has come to be associated with a variety of severe side effects including neurological damage, heart attacks, strokes, jaw decay, ovarian failure, and death.
What’s the problem?
According to the FDA warning, as many as 19 medical practices in the United States may have purchased unapproved cancer drugs from Quality Specialty Products (QSP), a foreign supplier that has also done business under the name Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.
Avastin is an injectable cancer treatment administered to patients in clinics, hospitals, and doctors’ offices nationwide. Although Genentech manufactures and markets Avastin in the United States, pharmaceutical giant Roche is the company that distributes Avastin for use in other countries. Packages may be counterfeit if they:
- are labeled with Roche as the manufacturer
- display batch numbers that start with B6010, B6011 or B86017
The FDA is advising medical practices that have obtained products from either Volunteer Distribution or QSP to stop using them and contact the administration immediately. These drugs should be kept and properly stored until they can be fully evaluated. Healthcare professionals and patients are encouraged to report adverse events related to the use of Avastin to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.