Irritable Bowel Syndrome Home > Lotronex and Pregnancy

Although Lotronex (alosetron) has not been studied in pregnant women, it did not appear to cause birth defects or other problems during animal studies. As a result, it is generally considered safe to take this drug during pregnancy. However, a healthcare provider should only prescribe it if the benefits of using the drug outweigh the potential risks to the unborn child.

Can Pregnant Women Take Lotronex?

Lotronex® (alosetron hydrochloride) is a prescription medication approved to treat irritable bowel syndrome (IBS) in women whose main symptom is severe diarrhea. Based on the results of animal studies, Lotronex is generally considered safe for use during pregnancy.

What Is Pregnancy Category B?

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. Lotronex is classified as a pregnancy Category B medicine.
Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
Lotronex has not been studied in pregnant women. In animal studies, the drug did not cause birth defects or other problems when given to pregnant rats or rabbits, even when given in very high doses.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.

Final Thoughts

If you are pregnant or thinking about becoming pregnant while taking Lotronex, let your healthcare provider know. He or she will consider both the benefits and risks before making a recommendation in your particular situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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