The FDA has classified Avandia as a pregnancy Category C medication, meaning that it may not be safe to take the drug during pregnancy. When Avandia was given to pregnant rabbits and rats in mid-to-late pregnancy, it was shown to cause miscarriages and decreased growth. If you are pregnant or thinking about becoming pregnant, be sure to talk to your healthcare provider about Avandia and pregnancy risk.
In September 2010, the U.S. Food and Drug Administration (FDA) announced that it was severely restricting the use of Avandia, 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 Avandia.
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.
Avandia 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.
Avandia was given a pregnancy Category C rating based on studies in pregnant animals. When given to pregnant rabbits and rats in mid-to-late pregnancy, Avandia caused miscarriages and decreased growth of the baby rabbits and rats. Avandia did not cause any problems when given to rats or rabbits early in pregnancy.
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):
Avandia [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.
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