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Caution on Viracept in Children and Pregnant Women

Posted on April 29, 2008

Pfizer is advising healthcare professionals to avoid treating certain children and pregnant women with the antiretroviral drug Viracept (nelfinavir mesylate).

The company says that patients taking Viracept have the potential to be exposed to an impurity called ethyl methanesulfonate (EMS). EMS is formed during the drug manufacturing process and it is a potential human carcinogen.

Pfizer is refining the manufacturing process to further limit the amount of EMS in Viracept. In the meantime, FDA and Pfizer have agreed that the drug can continue to be used in patients where the benefits outweigh the potential risks. The company has also issued guidelines for treating children and pregnant women during this interim period.

The guidelines state that until further notice, children who are starting HIV treatment should not be given Viracept. However, children who are stable on regimens that contain Viracept may continue to receive the drug because the benefits are considered to outweigh the risks in these cases.

The guidelines also state that pregnant women starting antiretroviral therapy should not be given Viracept at this time. Pregnant women who are currently receiving Viracept should be switched to an alternative antiretroviral therapy, if possible. But if a pregnant patient has no alternative treatment options, the benefits of continuing to use Viracept are considered to outweigh the risks.

Additional Information:

FDA MedWatch Safety Alert. Viracept (nelfinavir mesylate). September 10, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Viracept

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