FDA Warns of New Batch of Counterfeit Cancer Drug Avastin

CAMBRIDGE, UNITED KINGDOM - DECEMBER 10: Researchers Dr Sarah-Jane Dawson (R) and Dr Tim Forshew work at the Cancer Research UK Cambridge Research Institute on December 10, 2012 in Cambridge, England. The government has announced GBP £100million of funding to enable 100,000 patients with cancer and rare diseases to have their entire genetic code sequenced. (Photo by Peter Macdiarmid - WPA Pool/Getty Images) (Getty)

The Food and Drug Administration is warning doctors of another counterfeit version of the cancer drug Avastin.

In a post online Tuesday, the FDA said it had found at least one batch of the drug does not contain the active ingredient in real Avastin, which is used to treat cancers of the colon, lung, kidney and brain.

This is the third case involving the best-selling Roche drug in the last year.

The drug was distributed by Medical Device King, which also does business as Pharmalogical. The vials are packaged as Altuzan, the Turkish version of Avastin that is not approved for use in the U.S.

The agency is asking doctors to stop using any products from Medical Device King, Pharmalogical or Taranis Medical, another affiliated business.

An attorney for the Great Neck, N.Y.-based company pushed back against the FDA's claims, saying the company did not distribute the product in question.

"We are unaware of any proof which associates this batch, or any other such counterfeit products, to Pharmalogical," said attorney Richard Gertler, in a statement. He said the company has been cooperating with FDA's ongoing investigation of drugs distributed by a Canadian company, but added that "Pharmalogical has no association with the Canadian company."

The agency warned doctors in April about a similar case of fake Turkish Avastin distributed by a U.K. distributor. Prior to that, the FDA announced in February an investigation into a different batch of fake Avastin distributed to doctors in several states. Both of those cases appeared to involve different networks of distributors than the latest incident.

The FDA said it's currently unclear whether any U.S. patients have received the latest counterfeit drug. Specifically, Altuzan labeled with the lot numbers B6022B01 and B6024B01 may be counterfeit. Importing even authentic Altuzan into the U.S. is illegal, since the FDA has only reviewed Avastin as safe and effective.

Roche's Genentech unit sells Avastin in 120 countries and manufactures and packages the drug at eight sites worldwide. The drug had sales of $5.8 billion in 2012 and was Roche's second-best selling drug overall. The injectable drug usually sells for about $2,500 per vial.

The FDA warned doctors to be wary of drug prices that seem "too good to be true."

"Deep discounts may be offered because the product is stolen, counterfeit, substandard, or unapproved," the agency states.

Incidents of counterfeiting reported by drugmakers have increased steadily over the past decade, though only about 5 percent of cases are typically reported in the U.S. The rise in counterfeiting comes as pharmaceutical supply chains increasingly stretch across continents. More than 80 percent of the active ingredients used in U.S. pharmaceuticals are now manufactured overseas, according to a recent congressional report.

Based on reporting by the Associated Press.

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