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Counterfeit Avastin Distributed in the US

Jeannette Y. Wick, RPh, MBA, FASCP
Published Online: Tuesday, February 21, 2012

The fake cancer drugs took a circuitous route to the United States from Egypt via Europe, underscoring the potential dangers of a globalized drug supply chain.



The FDA issued a warning last week that a counterfeit version of Avastin (bevacizumab) (400 mg/16mL) missing the drug’s active ingredient had been distributed across the United States. Avastin, an injectable monoclonal antibody, is used to treat a number of types of cancer. The FDA has sent letters to 19 medical practices that it believes have purchased drugs from a foreign drug supplier known as Quality Special Products or Montana Health Care Solutions, which is the source of the counterfeit Avastin.
 
According to the FDA’s warning, pharmacists should be able to identify the counterfeit drugs based on their labels. The counterfeit drugs have labels that:
  • List Roche as the manufacturer. (The FDA-approved version of Avastin lists the manaufacturer as Genentech, Roche’s US biotech division.)
  • Have batch numbers that begin with B6010, B6011, or B86017. (The FDA-approved version has 6-digit batch numbers. Additionally the expiration dates are in 3-letter month and 4-digit year format, as in JAN 2014.)
  • Are written in French instead of English.
If you believe you have a counterfeit version of Avastin, the FDA recommends that you stop using it immediately and store it securely. Then, contact the FDA’s Office of Criminal Investigations (OCI) at (800) 551-3989, email DrugSupplyIntegrity@fda.hhs.gov, or visit the OCI’s website.
 
According to Reuters, the counterfeit agent traversed the globe. It apparently originated in Egypt and then was bought and sold sequentially by companies in Switzerland, Denmark, Britain, and the United States. The Danish company realized something was amiss and contacted its country’s regulators, who informed the British company, which discovered that the agent was on its way to the United States.
 
This safety breach highlights the global nature of the drug supply chain, which can offer opportunities for penetration by unauthorized suppliers. Pharmacists should be careful to only purchase drugs and biologics through authorized distributors and keep an eye out for labels that look suspicious.

Previous coverage of counterfeit drugs:
 
Exposing the Dangers of Illegal Online Pharmacies
Pfizer Warns of Fake Drugs Sold Online
Pulling the Plug on Rogue Pharmacies

Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy and a freelance writer from Virginia.
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