Avandaryl and Pregnancy
The FDA has classified Avandaryl as a pregnancy Category C medication, meaning that the medicine may not be safe to take during pregnancy. When one of the components of Avandaryl (rosiglitazone) was given to pregnant rats, there was an increased risk of miscarriages and a slowed growth rate in the fetal rats. The other component of Avandaryl (glimepiride) caused miscarriages in rats. Therefore, it's important to talk to your healthcare provider about Avandaryl and pregnancy.
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.
In September 2010, the U.S. Food and Drug Administration (FDA) announced that it would be severely restricting the use of rosiglitazone, one of the active ingredients in Avandaryl, due to the risk of "cardiovascular events" such as heart attacks and strokes. Only individuals who cannot control their diabetes on other medications (or those who are already taking the medication and doing well) will be able to take Avandaryl.
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.