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In animal studies on pregnancy and Azulfidine, the medication did not cause problems when given to pregnant rabbits and rats. As a result, the FDA has classified it as a pregnancy Category B medicine. Since the full risks are not known, however, the medication should only be prescribed if your healthcare provider believes that the benefits outweigh any possible risks.

Is Azulfidine Safe During Pregnancy?

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

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, Azulfidine did not cause any problems. A small survey in women suggested that the drug does not increase the risk of birth defects or miscarriages in pregnant women.
There have been a few reports of neural tube birth defects possibly associated with Azulfidine. This makes sense, because Azulfidine interferes with the absorption and metabolism of folic acid, and low folic acid intake has been associated with birth defects. 
However, it is important to note that animals do not always respond to medicines in the same way that humans do and that the full risks of using Azulfidine 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.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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