WelChol and Pregnancy
Since no human studies have been done on WelChol and pregnancy, the possible effects on human fetuses are unknown. The FDA classifies WelChol as a pregnancy Category B medicine, meaning it showed no negative effects on fetuses in animal studies. If you are taking WelChol and pregnancy occurs, your healthcare provider will weigh the benefits and risks in your particular situation.
WelChol® (colesevelam hydrochloride) is considered a pregnancy Category B medicine by the U.S. Food and Drug Administration (FDA), which means that it is probably safe for pregnant women, although the full risks are not currently known. When studied in pregnant animals, WelChol did not cause any problems.
WelChol and Pregnancy Category BThe 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 adequately studied in pregnant humans but that do not appear to cause harm to the fetus in animal studies.
Studies of WelChol in pregnant rats and rabbits revealed no problems. This was expected, since WelChol is not absorbed into the body. It stays in the digestive tract and, therefore, does not cross the placenta.
WelChol can decrease the absorption of fat-soluble vitamins. Therefore, you should take your prenatal vitamin at least four hours before your WelChol dosage.
However, animals do not always respond to medicines the same way that humans do. A pregnancy Category B medicine should be given to a pregnant woman only if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.