Avandaryl is a combination of two diabetes medicines that are used to control blood sugar levels in people with type 2 diabetes. The medication works by helping your body use its natural insulin better and by causing the pancreas to produce more insulin. It comes in a tablet form that is usually taken once a day. As with any medication, there are potential side effects, such as headaches, low blood sugar, and fluid retention.
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.
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.
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 April 10, 2012.
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