Possible carcinogen found in AIDS drug
Reuters | September 11, 2007
A potential human carcinogen has been found in batches of Pfizer Inc's AIDS drug Viracept, US regulators say.
Levels of the substance, ethyl methanesulfonate or EMS, were "substantially lower" than those that prompted Roche Holding AG to recall the same drug in Europe, a Pfizer letter to physicians said.
A Food and Drug Administration notice called EMS a "potential human carcinogen." Studies suggest EMS may cause cancer and birth defects in animals but no data in humans exist, the FDA and Pfizer said.
The agency and Pfizer agreed that pregnant women and children who are starting HIV therapy should not be given Viracept until further notice, the letter said.
Pediatric patients who are stable on Viracept-containing regimens may continue to be treated with the drug, the letter said.
Pregnant women currently taking Viracept should be switched to an alternative medicine while manufacturing changes are implemented to limit EMS levels, the letter added.
For pregnant women with no alternative treatment options, "FDA and Pfizer agree that the risk-benefit ratio remains favourable for the continued use of Viracept," the letter said.
A Pfizer spokeswoman could not immediately be reached for comment.
Pfizer shares were off 1.1 per cent, or 26 cents, to $23.99 in afternoon trading on the New York Stock Exchange.
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