Avandamet and Pregnancy
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 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 pregnancy Category C rating.
When rosiglitazone (one of the components of Avandamet) was given to pregnant rabbits and rats during mid-to- late pregnancy, it caused miscarriages and decreased the growth of the baby rabbits or rats. Rosiglitazone did not cause any problems to rats or rabbits when it was given early in pregnancy. However, it is important to note 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 pregnant woman outweigh any possible risks to the unborn child.
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of Avandamet during pregnancy before making a recommendation for your particular situation.