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Viracept Use in Pregnancy- Important News
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VIRACEPT (nelfinavir mesylate) 250 mg, 625 mg tablets, and Powder for Oral Suspension
IMPORTANT INFORMATION FOR PRESCRIBERS
May 6, 2008
Dear Healthcare Professional:
The purpose of this letter is to inform you that Pfizer and FDA have agreed on a final limit for ethyl methane sulfonate (EMS) in nelfinavir mesylate (active ingredient in VIRACEPT related impurity in nelfinavir mesylate (active ingredient in VIRACEPT) and provided to provide guidance on the use of VIRACEPT in patients.
On Sept 10, 2007, Pfizer informed prescribers of the preence of EMS, a process-related impurity in nelfinavir mesylate (active ingredient in Viracept) and provided guidance on the use of VIRACEPT in pregnant female and pediatric patients. At that time, FDA asked Pfizer to implement an interim specification to limit the presence of EMS in nelfinavir mesylate used in Pfizer's VIRACEPT products marketed in the United States, while continuing to work towards a long-term specification. Healthcare providers were advised not to initiate antiretroviral regimens containing VIRACEPT in their pregnant female and pediatric patients. In addition, pregnant females who were receiving VIRACEPT were to be switched to alternative anti-retroviral therapy unless no alternative therapy was available to them. For pediatric patients who were stable on VIRACEPT- containing regimens, the FDA and Pfizer agreed that the benefit-risk ratio remained favorable and those patients could continue to receive VIRACEPT. There was no change in the recommended use of VIRACEPT for all other patients.
Effective March 31, 2008, all VIRACEPT manufactured and released by Pfizer meets the new final limits established by the FDA for prescribing to all patient populations, including pregnant female and pediatric patients.
Please see enclosed full prescribing information.
Sincerely,
William A. Erhardt, M.D.
Vice President Specialty Medical
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