FDA announces it will review studies linking Avandia to heart attacks
February 23rd, 2010 by Jennifer Walker-Journey
It’s a long time coming. This week the Food and Drug Administration (FDA) announced it is reviewing the primary data from a large, long-term clinical study, known as RECORD, on possible cardiovascular risks associated with the diabetes drug Avandia (rosiglitazone). The agency said it is also reviewing on an ongoing basis a number of other published observational studies on the cardiovascular safety of the drug. The FDA’s announcement comes on the heels of news that two U.S. senators are asking why the GlaxoSmithKline (GSK) drug is still on the market when an FDA oversight board in 2008 urged the agency to pull the drug because it was causing 500 additional heart attacks a month. That request by the oversight board was based on the findings from the RECORD study.
According to the FDA’s announcement, the “FDA previously communicated to the public about the possible association between rosiglitazone and increased cardiovascular risk in a 2007 safety alert. The agency also sought advice from external experts at the July 30, 2007, joint meeting of the FDA Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. The RECORD study data represent the only new information from a completed randomized, controlled clinical trial of rosiglitazone received by FDA since the 2007 announcements.”
The RECORD study, which stands for Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes, was designed to evaluate the cardiovascular safety of rosiglitazone. This practice is consistent with the FDA’s December 2008 Guidance for Industry that recommends that manufacturers of new treatments for diabetes carefully design their clinical trials to include an evaluation of cardiovascular safety.
Once the FDA has completed its review of rosiglitazone, the agency will present its findings at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.
Rosiglitazone, a treatment for Type 2 diabetes, is sold as a single-ingredient product under the brand name Avandia, and is available in combination with other diabetes medications, such as metformin, under the brand name Avandament, or glimepride, under the brand name Avandaryl. The FDA advises that patients who are currently taking any form of rosiglitazone should not stop taking their medication without first talking to their healthcare professional. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.