Animal studies on mesalamine and pregnancy showed that the medication did not cause any complications for the fetus. However, since the full risks of using the drug in pregnant women are not known, healthcare providers will only prescribe it if the benefits outweigh the risks. If you are taking mesalamine and pregnancy occurs, your healthcare provider will consider your particular situation before making a recommendation.
Is Mesalamine Safe During Pregnancy?
Mesalamine is likely safe for pregnant women, although the full risks are not known.
Mesalamine 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, mesalamine 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 the drug while pregnant 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.
Mesalamine and Pregnancy: Recommendations
If you are pregnant, or are thinking about becoming pregnant while taking mesalamine, let your healthcare provider know. He or she will consider the benefits and risks of taking the drug while pregnant before making a recommendation in your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Delzicol [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC;2013 February.
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