Although animal studies on Viracept and pregnancy show that the drug is probably safe for pregnant women, the manufacturer of the medication has issued a warning about the safety of the medicine. Ethyl methanesulfonate, an impurity caused by the manufacturing process and that may cause cancer, has been found in Viracept products. If you are taking Viracept and pregnancy occurs, let your healthcare provider know immediately.
Viracept and Pregnancy: An Overview
Viracept® (nelfinavir mesylate) is a prescription HIV treatment. Based on animal studies, the drug is probably safe for use during pregnancy. However, a recent warning suggests that pregnant women should not take Viracept.
Viracept and Pregnancy Category B
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
However, the manufacturer of Viracept has sent letters to healthcare providers warning that ethyl methanesulfonate (EMS) has been found in Viracept products. EMS is an impurity caused by the manufacturing process of Viracept and may cause cancer. The risk of cancer due to taking Viracept appears to be low, and for most people, the benefits of Viracept outweigh the possible risks of cancer due to EMS. However, this risk may be higher in developing fetuses, and it is currently recommended that pregnant women avoid taking Viracept until more information is available. If you are taking Viracept, your healthcare provider may recommend that you switch to a different medication.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Viracept [package insert]. Research Triangle Park, NC: ViiV Healthcare Company;2012 April.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 7th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2005.
Berelowitz M. Viracept important information for prescribers (9/10/2007). Pfizer's Viracept Web site. Available at: http://www.viracept.com/pdf/VIRACEPT_HCPLetter_9_10_07.pdf. Accessed October 9, 2007.
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