The Food and Drug Administration (FDA) announced it would be reviewing data submitted in August 2009, from a large, long-term clinical study (RECORD study) on possible risks associated with the diabetes drug, Avandia (rosiglitazone).
The FDA said it will complete its review of the data from the RECORD study, and will then 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. At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.
Until then health-care professionals prescribing Avandia should follow the recommendations in the drug label.
Patients already using the drug should continue taking it unless told otherwise by their health-care professional. Patients who are concerned about the possible risks associated with use of Avandia should talk to their health-care professional.