Avandaryl and Pregnancy

Avandaryl During Pregnancy -- Is It Safe?

For women who are pregnant, Avandaryl^® (rosiglitazone and glimepiride) may not be safe. This is based on animal studies that looked at the effects of Avandaryl during pregnancy.

 

Avandaryl and Pregnancy Category C

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.

 

In animal studies, giving large doses of rosiglitazone (one of the components of Avandaryl) to pregnant rats increased the risk of miscarriages and slowed the growth of the fetal rats. The other component of Avandaryl (glimepiride) has been shown to cause miscarriages in rats. However, it is important to note that animals do not always respond to medicines in 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 woman outweigh any possible risks to the unborn child.