FDA Reviewing Avandia Cardiovascular Safety

The organization will provide a complete efficacy and safety assessment of the drug in July 2010

TUESDAY, Feb. 23 (HealthDay News) -- The U.S. Food and Drug Administration has informed health care professionals that the organization is currently reviewing cardiovascular safety data associated with rosiglitazone (Avandia), a type 2 diabetes drug, from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) study as well as from other recently published safety analyses.

The organization has not released any recommendations or made any conclusions regarding the cardiovascular safety of rosiglitazone. However, the FDA currently recommends that practicing clinicians continue to follow the rosiglitazone prescribing information, which includes a boxed warning.

The FDA will provide an assessment of the efficacy and safety of rosiglitazone during a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010. Patients should continue taking the drug unless otherwise notified by their health care practitioner, making sure to question their provider with any concerns or adverse reactions.

"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," according to the Feb. 22 safety notification issued by the agency.

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