FDA reviews cardiovascular safety of Avandia

The FDA has notified healthcare professionals and patients that it is reviewing the primary clinical trial data from the long-term RECORD study to evaluate the cardiovascular safety of Avandia (rosiglitazone tablets, from GlaxoSmithKline). The review is ongoing and no new conclusions or recommendations about the use of Avandia have been made at this time. Once the FDA completes its review of the data, it will present the totality of new and existing cardiovascular safety data on Avandia at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.

When prescribing Avandia, healthcare professionals should follow the recommendations in the drug label. Patients should continue taking Avandia unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using Avandia should talk to their healthcare professional.

Avandia is a thiazolidinedione indicated as an adjunct to diet and exercise in type 2 diabetes, as monotherapy, or in combination with metformin and/or a sulfonylurea.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201446.htm.