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FDA Warns of Counterfeit Version of Avastin Cancer Treatment

February 14, 2012

The U.S. Food and Drug Administration issued a safety alert on Feb. 14 to warn the public about the dangers posed by a counterfeit version of the Avastin® cancer treatment being distributed in the United States.

Bevacizumab is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor. The drug is used approved for the treatment of colon cancer and is covered in a patent 6,054,297 owned by Genentech Inc.

The FDA here is warning healthcare professionals and patients about a counterfeit version of the injectable Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin and purports to be manufactured by Roche, but does not contain the medicine's active ingredient, bevacizumab. Roche only manufactures Avastin approved for marketing outside of the United States; the only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche).  According to the FDA, 19 practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.

Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

  • are labeled with Roche as the manufacturer
  • display batch numbers that start with B6010, B6011 or B86017

The FDA-approved version does not include the Roche logo on the packaging or vials. To report suspected counterfeit products, please:

  • Call FDA's Office of Criminal Investigations (OCI) at 800-551-3989,
  • Visit OCI's website, or
  • This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Read the Genentech press release on this safety alert.



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