Apriso and Pregnancy
In animal studies on Apriso and pregnancy, the medication did not cause any problems when it was given to pregnant rats and rabbits. Since there are no adequate studies on the use of mesalamine (the active ingredient in Apriso) in humans, however, there may be risks that are currently unknown. Therefore, if you are taking this medication and pregnancy occurs, talk to your healthcare provider immediately.
Apriso™ (mesalamine) is a prescription medication used to treat ulcerative colitis. It is probably safe for pregnant women, although the full risks are not currently known.
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, mesalamine (the active ingredient of Apriso) did not cause any problems. Additionally, most reports of mesalamine use in pregnant women indicate that the drug is probably safe in pregnant humans as well.
However, because there are no adequate studies of mesalamine use in humans, there may possibly be risks that are currently unknown. Therefore, Apriso 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.
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. He or she will consider both the benefits and risks of this drug before making a recommendation for your particular situation.