An AIDS drug manufactured by Pfizer contains a human carcinogen due to an effect of the manufacturing process. Viracept is not being recalled but a warning letter is being issued to doctors. A similar drug manufactured in Europe by Roche Ltd. was recalled.
The U.S. Food and Drug Administration said, however, that some patients might already have been exposed to EMS levels higher than what the FDA considers to be an acceptable limit.
Still, the FDA has decided against a recall of Viracept manufactured by Pfizer because of the lower levels of EMS in the drug when compared to the levels found in Europe.
The FDA feels the risk of not taking the protease inhibitor is far lower than the risk of taking the drug. The carcinogen is ethyl methanesulfonate.
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