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.
In September 2010, the U.S. Food and Drug Administration (FDA) announced that it was severely restricting the use of Avandaryl, due to the risk of "cardiovascular events" such as heart attacks and strokes. Only individuals who could not control their diabetes on other medications (or those who were already taking the medication and doing well) would be able to take Avandaryl.
However, in November 2013, the FDA announced that a careful analysis of the research suggests that there is not, in fact, any increased risk, compared to treatment with standard diabetes medications and that the use of this medication will no longer be restricted.
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.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Avandaryl [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2011 February.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines (November 25, 2013). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm376389.htm. Accessed December 20, 2013.
Food and Drug Administration, Center for Drug Evaluation and Research. Avandia (rosiglitazone): REMS - risk of cardiovascular events (9/23/2010). FDA Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm. Accessed October 1, 2010.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click