Health Canada Determines Viracept (nelfinavir mesylate) Can Be Used Again in Non-Pregnant HIV-Infected Adults and Children

OTTAWA, ONTARIO–(EMWNews – Aug. 21, 2008) – Following up on a Public Communication issued September 10, 2007, Health Canada wishes to inform Canadians and Canadian health care professionals that Health Canada and Pfizer Canada have agreed on an acceptable ethyl methanesulfonate limit for Viracept, a drug used in the treatment of HIV/AIDS. Health Canada would like to assure Canadians that the Viracept product now available on the Canadian market has the acceptable ethyl methanesulfonate limits so that the precautions relating to its use in non-pregnant HIV infected adults and children no longer apply.

Health Canada would also like to remind Canadians of its advice against the use of Viracept in pregnant women due to safety concerns regarding ethyl methanesulfonate during pregnancy.

In September 2007, Health Canada was made aware of international findings of low levels of a toxic impurity in Viracept. As a result, Pfizer Canada, in collaboration with Health Canada, advised health care professionals to switch pregnant women and children using Viracept to other available HIV/AIDS medications as soon as possible.

At that time, in consultation with Health Canada, Pfizer Canada immediately began working to limit the levels of ethyl methanesulfonate formed in Viracept during the manufacturing process. The U.S. FDA also requires the same acceptable ethyl methanesulfonate limits for Viracept on their market.

Health Canada continues to work with Pfizer Canada to ensure the Viracept product on the Canadian market does not exceed the acceptable ethyl methanesulfonate limit. Canadians will continue to be informed if new safety information arises.

More information on the VIRACEPT Dear Health Care Professional Letter, (http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2007/viracept_hpc-cps-eng.php) and/or the VIRACEPT Public Communication (http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2007/viracept_pc-cp-eng.php) is available on the Health Canada Web site.

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