Remicade and Pregnancy
Based on the results of animal studies with Remicade, the FDA has classified it as a pregnancy Category B medication. This means that it does not appear to cause harm to the fetus. However, the full risks of taking the drug during pregnancy are not known. If you are taking Remicade and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation.
Is Remicade Safe During Pregnancy?Remicade® (infliximab) is generally considered safe to take during pregnancy. In animal studies, medications similar to Remicade did not appear to cause any problems when given to pregnant animals.
Remicade and Pregnancy Category BThe 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.
Animal studies did not use Remicade specifically, as the drug does not work in most animals. However, medications that are similar to Remicade did not appear to cause problems when given to pregnant mice. Remicade has not been adequately studied in pregnant women. One small study in the December 2004 edition of The American Journal of Gastroenterology found that the drug did not increase the risks of problems in the mothers or babies.
It is important to note that animals do not always respond to medicines in the same way that humans do and that Remicade itself has not been adequately studied in pregnant women or animals. Therefore, a pregnancy Category B medicine may 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.