February 04, 2011
Avandia label updated to include cardiovascular risk warningsThe FDA is notifying the public that the labeling for Avandia (rosiglitazone tablets, from GlaxoSmithKline) has been updated to include information about associated cardiovascular risks. In September 2010, the FDA announced that it would restrict the use of rosiglitazone to patients with type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events (eg, heart attack and stroke) in patients treated with rosiglitazone.
At this time, the FDA has only approved these safety-related changes to the Prescribing Information and Medication Guides for the rosiglitazone-containing medicines, including Avandamet (rosiglitazone and metformin, from GlaxoSmithKline) and Avandaryl (rosiglitazone and glimepiride, from GlaxoSmithKline). The Risk Evaluation and Mitigation Strategy (REMS), which will restrict rosiglitazone-containing medicines' availability, is expected to be approved by Spring 2011 and implemented by the manufacturers six months thereafter.
Avandia is 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/Drugs/DrugSafety/ucm241411.htm.