ST LOUIS (MD Consult) - On February 22, 2010, the US Food and Drug Administration (FDA) announced that it is reviewing the primary data from a large, long-term clinical study known as Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) in regard to possible cardiovascular risks associated with use of Avandia (rosiglitazone), a drug indicated for the treatment of diabetes. In addition, the FDA has been conducting an ongoing review of data from a number of published observational studies in regard to the cardiovascular safety of rosiglitazone. At this time, the FDA has drawn no new conclusions or made any new recommendations about the use of rosiglitazone in the treatment of type 2 diabetes.
The RECORD study findings were published in the June 20, 2009, issue of The Lancet (abstract).
The FDA previously communicated to the public about the possible association between rosiglitazone and increased cardiovascular risk. The agency also sought advice from external experts about this issue at a July 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 the FDA since the 2007 announcements.
After the FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.
When prescribing rosiglitazone, health care professionals are advised to adhere to the recommendations outlined in the drug label. The label includes a Boxed Warning that states that use of rosiglitazone in patients with established New York Heart Association class III or IV heart failure is contraindicated. Furthermore, rosiglitazone is not recommended for patients with symptomatic heart failure. In addition, rosiglitazone causes or exacerbates congestive heart failure in some patients, and prescribers are advised to monitor their patients for the signs and symptoms of heart failure after starting treatment with the drug and after dose increases.
Patients are being advised to continue taking rosiglitazone unless otherwise instructed and are being encouraged to discuss any concerns with their health care professional.
Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. It is also available in combination with other diabetes medications. Combined with metformin, it is sold under the brand name Avandamet, and combined with glimepiride, it is sold under the brand name Avandaryl.
