FDA Issues Another Warning on Fake Version of Cancer Drug Avastin

Patients who take the product would get no benefit, agency says

By Robert Preidt

Wednesday, February 6, 2013

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WEDNESDAY, Feb. 6 (HealthDay News) -- Doctors need to be on the lookout for another counterfeit version of the injectable cancer drug Avastin (bevacizumab), the U.S. Food and Drug Administration warned on Wednesday.
Lab tests revealed that at least one batch of the counterfeit medicine -- distributed by the U.S. company Medical Device King (also known as Pharmalogical) -- contains no active ingredient.
The counterfeit bevacizumab is marketed as Roche's Altuzan, which is not approved for sale in the United States, the FDA noted. The only approved version of bevacizumab for sale in the United States is Avastin, which is marketed by Genentech.
Altuzan 400 mg/16 mL may be counterfeit if it is labeled as batch B6022B01 with an expiration date of November 2013 or batch B6024B01 with an expiration date of February 2013, the agency said.
The FDA also warned doctors, hospitals and patients to "be wary if the price of a medicine sounds too good to be true. Deep discounts may be offered because the product is stolen, counterfeit, substandard or unapproved."
The FDA said it doesn't know at this point if any patients were given the counterfeit version of the drug, the Associated Press reported. Avastin is used to treat colorectal, brain, lung and kidney cancers.
Medical practices that have received any products from Medical Device King, Pharmalogical or Taranis Medical (another company associated with Pharmalogical) should quit using these products because they might prove hazardous or ineffective, the FDA said.
Anyone with these medicines also should contact the FDA's Office of Criminal Investigations to arrange for pickup.
This is the third case of counterfeit Avastin being sold in the United States in the past year, the AP reported.
In February 2012, the agency said it was investigating a batch of counterfeit Avastin distributed to doctors in several states. In April 2012, the FDA warned doctors about fake Avastin distributed by a U.K. company.
Those two cases appeared to involve different networks of distributors than the latest episode, the AP reported.

SOURCES: U.S. Food and Drug Administration, news release, Feb. 5, 2013; Associated Press

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