FDA allows drugmakers to sell generic Chantix, says cancer risk minimal

The FDA is allowing drugmakers to distribute varenicline, the generic name for Pfizer's anti-smoking drug Chantix, even if the drug contains low levels of a carcinogen. The health benefits of quitting smoking outweigh the cancer risk from the carcinogen in the drug, the agency said. 

In late June, Pfizer halted global distribution of Chantix after finding that some pills contain elevated levels of the carcinogen N-nitroso-varenicline. Pfizer recalled nine lots of the drug, though the FDA said there was no immediate risk from taking the medication, since the increased cancer risk associated with the carcinogen in the drug would only come from long-term use. 

The FDA said July 16 that it will allow drugmakers to continue distributing the drug even if it contains a low level of the carcinogen to make sure patients still have access to it. It's letting drugmakers distribute the drug if it contains levels of the carcinogen between 37 nanograms per day and 185 nanograms per day. 

The agency said scientists have evaluated the risk of exposure to the carcinogen at levels up to 185 nanograms per day and determined it presents a minimal cancer risk. 

It urged patients taking varenicline to continue taking the drug until a pharmacist provides a replacement or a physician prescribes a different drug. 

Read the FDA's full news release here

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