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.
If you have type 2 diabetes, Avandia® (rosiglitazone maleate) is a medicine that your healthcare provider may recommend. This prescription drug is approved for treating this form of diabetes either by itself or in combination with other medications.
As a thiazolidinedione (or sometimes called "glitazones") medicine, Avandia works to treat type 2 diabetes by improving insulin sensitivity. This means that this medication helps your body use its natural insulin better, which, in turn, helps to lower blood sugar and keep it under better control.
Avandia comes in the form of a tablet and is typically taken once or twice a day. Although most people tolerate this medication well, it is not suitable for everyone. Before starting treatment with this type 2 diabetes medicine, Avandia warnings and precautions should be fully reviewed with your healthcare provider. For example, potential side effects include headaches, back pain, and upper respiratory infections.
(Click Avandia to learn more about this type 2 diabetes medicine. This article also discusses the effects of Avandia on the body, lists other potential side effects, and explains what to tell your healthcare provider before starting treatment.)
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.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed January 16, 2007.
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