PrandiMet and Pregnancy
It is not known if it is safe to use PrandiMet during pregnancy. PrandiMet (repaglinide and metformin) is considered a pregnancy Category C medication, as one of its components has been shown to cause problems in animal fetuses. When used in very high doses, repaglinide (one of the medications in PrandiMet) did cause certain skeletal defects. However, it is not known if the same problems would occur in humans.
An Overview of Using PrandiMet During PregnancyPrandiMet™ (repaglinide and metformin) is a prescription diabetes medication. At this time, it is not clear if PrandiMet is safe for use in pregnant women.
Pregnancy Category CThe 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 C is given to medicines that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a "default" pregnancy Category C rating.
PrandiMet contains two different medications, metformin and repaglinide. In general, metformin is usually considered relatively safe for use in pregnancy (see Metformin and Pregnancy). It is not known if repaglinide is equally as safe. In animal studies, repaglinide did not cause birth defects or miscarriages at normal doses, although it did cause certain skeletal defects at very high doses. It is not known if similar problems could occur in humans.
A pregnancy Category C medicine may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.