Herbal Spotlight
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 nelfinavir mesylate |
| Viracept |
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Pharmaceutical
company:
Pfizer, Inc.
www.pfizer.com |
NEW WARNING
Pfizer sent a "Dear Healthcare Professional" letter to report the presence of ethyl methanesulfonate (EMS) in their antiviral drug nelfinavir (Viracept) and to provide guidance on the use of nelfinavir in children and pregnant women. Though there's no clear data on the impact of high levels of EMS over time, it's a known carcinogen, and the risk associated with it is greatest in children under age 2 years and is high in children ages 2 to 16 years. The FDA feels that if a child is stable on a Viracept-containing regimen, the risk to benefit ratio favors leaving the child on that regimen. If a child is to start on an antiviral therapy, a Viracept-containing regimen shouldn't be used. The FDA is also recommending that pregnant women limit their exposure to Viracept. A pregnant woman who's to be started on antiviral therapy shouldn't be started on a regimen containing Viracept. If a woman is pregnant and is currently receiving Viracept, it's recommended that she be switched to a regimen that doesn't contain Viracept. If there's no other option for treatment, the benefit risk ratio would favor staying on the Viracept-containing regimen. There are currently no changes in prescribing guidelines for other patients taking this drug as part of their anti-HIV regimen.
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