FDA Drug Safety Communication

FDA is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug Avandia (rosiglitazone). The clinical study, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes or RECORD study was designed to evaluate the cardiovascular safety of rosiglitazone, a medication used to treat type 2 diabetes mellitus. In addition to the RECORD study, a number of observational studies of the cardiovascular safety of rosiglitazone have been published. FDA has been reviewing these on an ongoing basis.

FDA is now reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time.

When prescribing rosiglitazone, healthcare professionals should follow the recommendations in the drug label including the Boxed Warnings. Rosiglitazone is sold as a single-ingredient product under the brand name Avandia and is also available in combination with other diabetes medications: metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

View the full FDA Drug Safety Communication on FDA.gov