Diabetes Home > Actoplus Met and Pregnancy
According to animal studies on Actoplus Met and pregnancy, the medication increased the risk of miscarriages and slowed down the growth of fetuses. As a result, the FDA has labeled Actoplus Met a pregnancy Category C drug, even though it hasn't been studied in humans. If you are taking Actoplus Met and pregnancy occurs, your healthcare provider will weigh the benefits to you against the risks to your unborn child before making a recommendation.
Actoplus Met® (pioglitazone and metformin) may not be safe for pregnant women. This is based on animal studies that looked at the effects of the drug during pregnancy. Actoplus Met is a combination of two different diabetes medications: pioglitazone hydrochloride (Actos®) and metformin hydrochloride (Fortamet®, Glucophage®, Glucophage XR®, Glumetza®, or Riomet®).
The 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 C is given to medicines that have not been studied in pregnant humans but that did appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals automatically are given a pregnancy Category C rating.
In animal studies, giving large doses of pioglitazone (one of the components of Actoplus Met) to pregnant rats increased the risk of miscarriages and slowed down the growth of the fetal rats. It is important to note, however, that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.