Women who are pregnant are advised to avoid Xenical (orlistat). This medication has been given a pregnancy Category X rating, due to the fact that weight loss is generally not recommended during pregnancy. If you are taking Xenical and pregnancy occurs, consult your healthcare provider.
Xenical and Pregnancy: An Overview
Xenical® (orlistat) is a prescription weight loss aid that is likely safe for use during pregnancy. When given to pregnant animals, the drug did not cause any problems. Nonetheless, this drug should not be used during pregnancy.
Xenical and Pregnancy Category X
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
In studies, giving very high doses of Xenical to pregnant rats and rabbits did not cause any problems. Initially, Xenical was given a pregnancy Category B rating, indicating that it was likely quite safe for use during pregnancy (as a comparison, Tylenol®, a drug very commonly used in pregnancy, is also a Category B drug).
However, in 2012 the rating was changed to an X rating (the most severe rating that can be given to warn women to avoid use during pregnancy). The known risks have not changed -- there is no new information that might suggest the drug could be dangerous. However, because weight loss is not recommended during pregnancy at all, even in obese women, the risks (however small) outweigh any possible benefits.
Xenical and Pregnancy: Final Thoughts
If you are pregnant, it is always a good idea to ask your healthcare provider before taking any medication (including prescription products). You and your healthcare provider can consider the possible risks and benefits of using Xenical in your particular situation, as well as any other treatment alternatives. In all imaginable cases, this medication is not a good idea for pregnant women.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Xenical [package insert]. South San Francisco, CA: Genentech USA, Inc.;2013 October.
Lexi-Interact [computer program]. Lexi-Comp, Inc.; August 24, 2007.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: Approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed August 24, 2007.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 7th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2005.
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