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Animal studies on Pentasa and pregnancy showed that the drug did not cause any problems when given to pregnant rats and rabbits. However, because animals and humans do not always respond to drugs in the same way, the full risks are not known. If you are taking Pentasa and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation.

Is Pentasa Safe During Pregnancy?

Pentasa® (mesalamine) is probably safe for pregnant women, although the full risks are not known.

Pentasa and 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. Pregnancy Category B is given to medicines that have not been studied in pregnant humans but that do not appear to cause harm to the fetus in animal studies
When given to pregnant rats and rabbits, Pentasa did not cause any problems. However, it is important to note that animals do not always respond to medicines the same way that humans do and that the full risks of using Pentasa during pregnancy are not known. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if her healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.

Pentasa and Pregnancy: Recommendations

If you are pregnant, or are thinking about becoming pregnant, while taking Pentasa, let your healthcare provider know. He or she will consider both the benefits and risks using the drug during pregnancy 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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