Avandamet and Pregnancy

It is generally not recommended to use Avandamet during pregnancy. This is because during animal studies on Avandamet and pregnancy, the diabetes medication was shown to decrease the growth of babies and cause miscarriages during mid-to-late pregnancy. Since animals do not always respond to medicines that same way that humans do, Avandamet can still be given to a pregnant woman if her healthcare provider believes that the benefits outweigh any possible risks to the unborn child.

Avandamet During Pregnancy -- Is It Safe?

For people who are pregnant, Avandamet® (rosiglitazone and metformin) may not be safe. This is based on animal studies that looked at the effects of Avandamet during pregnancy. Avandamet is a combination of two different diabetes medications: rosiglitazone maleate (Avandia®) and metformin hydrochloride (Fortamet®, Glucophage®, Glucophage XR®, Glumetza®, or Riomet®).
 
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 Avandamet, 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 Avandamet.
 

Avandamet 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.
 
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.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD
 
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