In previous animal studies involving Asacol and pregnancy, the medication did not cause any problems when it was given to pregnant rats and rabbits. However, it is important to keep in mind that animals do not always respond to medicines in the same way that humans do, and that the full risks of using Asacol during pregnancy are not known.
Asacol® (mesalamine) is probably safe for pregnant women. However, the full risks of taking this medicine during pregnancy are not known.
Asacol and Pregnancy Category B
The U.S. Food and Drug Administration (FDA) uses a pregnancy 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 do not appear to cause harm to the fetus in animal studies.
When given to pregnant rats and rabbits, Asacol did not cause any problems.
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 Asacol during pregnancy are not known. Therefore, Asacol should be given to a pregnant woman only if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
Recommendations for Asacol and Pregnancy
If you are taking Asacol and pregnancy occurs (or you are thinking about becoming pregnant), let your healthcare provider know. He or she will consider both the benefits and risks of Asacol during pregnancy before making a recommendation for your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Asacol [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC;2013 October.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 7th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2005.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed July 1, 2013.
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