The Food and Drug Administration is warning doctors that a second counterfeit version of the best-selling cancer drug Avastin has been found in the U.S., packaged as the Turkish brand of the medication.
The FDA said late Tuesday that the counterfeits do not contain the active ingredient in Avastin, which is used to treat cancers of the colon, lung, kidney and brain. The vials are packaged as Altuzan, the Turkish version of Avastin that is not approved for use in the U.S. The agency says any packages or vials labeled with the lot number B6021 should be considered counterfeit.
Doctors bought the counterfeits through Richards Pharma, a U.K.-licensed distributor that also does business as Richards Services, Warwick Healthcare Solutions and Ban Dune Marketing Inc.
British regulators said Wednesday that Richards Pharma imported 120 packs of the fake Altuzan from Turkey. Thirty-eight packets were shipped directly to the U.S., while the rest were sold to another U.K. distributor who then shipped them to the U.S. U.K. authorities were notified of the fake product by the FDA on March 28, according to a statement from the country's Medicines and Healthcare Products Regulatory Agency.
The agency is advising doctors to stop using any drugs acquired from the network. No deaths have been reported in connection with the counterfeits.
In February the FDA announced an investigation into a different batch of fake Avastin distributed to doctors in several states. Those counterfeits appeared to have moved through a different network of distributors. European regulators traced the packages through Britain, Denmark, Switzerland and the Middle East. The original country of origin remains unclear.
Roche sells Avastin in 120 countries and manufactures and packages the drug at eight sites worldwide. The company is headquartered in Switzerland.
A spokeswoman for Roche's Genentech unit said authentic Altuzan packaging has text in Turkish, while the counterfeit packages obtained by the FDA have English text. She added that importing even authentic Altuzan into the U.S. is illegal.
"The only Avastin that can be legally purchased by wholesalers in the United States is FDA-approved Avastin manufactured by Genentech," said Charlotte Arnold, in a statement.
Incidents of counterfeiting reported by drugmakers have increased steadily over the decade to more than 1,700 worldwide last year. Only 6 percent of those were 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.