| Subject: | FDA Issues Information about an Impurity in Viracept and Guidance on Viracept use in Pregnant Women and Pediatric Patients |
| Category: | Food and Drug Administration (FDA)
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| Published: | Tue, 11 Sep 2007 - 12:30 pm |
| Audience: Infectious disease specialists, pediatricians, pharmacists, other healthcare professionalsThe FDA has announced that Pfizer, Inc. has issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in Viracept and to provide guidance on the use of Viracept in pregnant women and pediatric patients. EMS is a potential human carcinogen. Data from animal studies indicate EMS is teratogenic,... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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