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Pfizer alerts doctors about impurities in AIDS drug

Submitted by Natural Solutio... on Mon, 2007-09-10 13:51
in

Mon Sep 10, 2007

WASHINGTON, Sept 10 (Reuters) - Pfizer Inc. has alerted doctors about impurities found in batches of the AIDS drug Viracept, U.S. regulators said on Monday.

Levels of the substance, ethyl methanesulfonate or EMS, were "substantially lower" than those that prompted Roche Holding AG  to recall the product in Europe, a Pfizer letter to physicians said.

Studies suggest EMS may cause cancer and birth defects in animals, but no data in humans exists.

The FDA and Pfizer agreed that pregnant women and children who are starting HIV therapy should not be given Viracept until further notice, the letter said.

((Reporting by Lisa Richwine, editing by Paul Thomasch; Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: PFIZER VIRACEPT/

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