The Federal Drug Administration (FDA) has issued an alert that a counterfeit batch of bevacizumab (labeled Altuzan and having no active ingredient) has been found in the U.S. The counterfeit version with a Roche Altuzan label was distributed by a U.S. company Medical Device King (also known as Pharmalogical).
Even if it was not counterfeit, Altuzan is not FDA-approved for U.S. distribution. The only FDA-approved version of bevacizumab for U.S. sale is Avastin, marketed by Genentech.
Medical practices that have obtained any medical products from Medical Device King, Pharmalogical, or Taranis Medical should stop using the products and contact FDA’s Office of Criminal Investigations to arrange collection. The FDA has repeatedly urged medical practices not to obtain drugs from non-verified (and often unlicensed) sources.
One year ago, a similar counterfeit version of bevacizumab with a Roche label was given to cancer patients by at least 19 U.S. medical practices.
The problem of counterfeit drugs is not new: Last January 2012, the FDA warned healthcare providers not to buy injectable cancer medications from “direct-to-clinic” promotions or non-verified sources:
“Health care providers are reminded to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States.”
“Counterfeiting has become more and more prevalent in developed countries as drug supply chains increasingly cross continents.”
Last summer (August 2012) Fight Colorectal Cancer joined with five other cancer organizations urging Congress to adopt proposed legislation to tighten security by creating a national pharmaceutical distribution standard including:
- Placing serial numbers on each package, or unit, of medicine;
- Implementing a system that tracks medicine at this unit level as they move from the manufacturers to the patient; and
- Phased-in regulations to ensure that pharmacies and clinics are using the new “track and trace” system to protect patients.
Carlea Bauman, president of Fight Colorectal Cancer, said today, “We continue working closely with both the FDA and Congress to get a more secure national distribution system because counterfeit drugs may endanger cancer patients’ lives.”
More information about current counterfeit drug
The FDA bulletin contains batch numbers involved, tips for spotting counterfeit drug labels, and contact numbers for reporting or getting more information on this or any drug or device.
Disclosure: Fight Colorectal Cancer has accepted funding for projects and educational programs from Genentech, maker of Avastin, in the form of unrestricted educational grants. Fight Colorectal Cancer has ultimate authority over website content.