Alli and Pregnancy

Pregnant women are typically advised not to lose weight. The FDA has given Xenical (the prescription version of Alli) a pregnancy Category X rating, meaning it should be avoided during pregnancy. If you are taking Alli and pregnancy occurs, talk to your healthcare provider before continuing treatment.

Alli and Pregnancy: An Overview

Alli™ (orlistat) is a non-prescription weight loss aid. The manufacturer of the drug warns that pregnant women should not take Alli. However, animal studies suggest that it is probably safe for use during pregnancy. Nonetheless, this drug should not be used during pregnancy.

Alli 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.
Xenical®, the prescription version of Alli (which contains the same active ingredient in a higher strength), is a pregnancy Category X medication. Therefore, Alli is also a pregnancy Category X medication.
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.
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