FDA issues warning about counterfeit bevacizumab

The U.S. Food and Drug Administration issued a warning to health care providers alerting them that a counterfeit version of bevacizumab may have been purchased or used by medical practices in the United States.

The agency also sent letters to 19 medical practices across the country alerting them that they purchased unapproved medications — possibly including the counterfeit bevacizumab (Avastin, Genentech) — from Quality Specialty Products, a foreign supplier that also uses the name Montana Health Care Solutions.

The FDA urged the practices to stop using any products they have from Quality Specialty Products or one of its distributors, Volunteer Distribution of Gainesboro, Tenn.

The FDA warning indicates that packages or vials labeled as Avastin 400 mg/16 mL may be counterfeit if they list Roche — which manufacturers bevacizumab approved for marketing outside of the United States — as the manufacturer, or if they display batch numbers that start with B6010, B6011 or B86017.

The FDA-approved version of bevacizumab — an injectable medicine — is marketed by Genentech, a member company of Roche, and does not include the Roche logo on the packaging or vials.

The words "Genentech" or "Genentech, a member of the Roche Group" are printed on the labels of cartons and vials approved for use in the United States. The lot number on the carton and vial should be six digits with no letters, the companies said.

The FDA-approved version also includes an expiration date formatted as a three-letter month and four-digit year, such as JUL 2014, and there is no manufacturing date printed on the carton or vial. All of the text on vial labels, cartons and package inserts are in English.

"The counterfeit product is not safe or effective and should not be used," Roche and Genentech said in a statement. "Chemical analyses of the counterfeit vials tested to date have confirmed the product does not contain the active ingredients for Avastin. Patient safety is Roche and Genentech's primary concern. We are working with the U.S. Food and Drug Administration and law enforcement to aid their evaluations, determine the source of the counterfeit drug and prevent its further distribution."

The FDA urged health care professionals who believe they have counterfeit versions of bevacizumab — as well as those who have received any other products from QSP or Volunteer Distribution — to stop using them, store them securely and call the FDA's Office of Criminal Investigations at 800-551-3989.

Health care providers who believe patients are experiencing side effects different from those commonly associated with bevacizumab are urged to call the FDA's MedWatch program at (800) FDA-1088.