FDA releases restrictions on Avandia for Type 2 Diabetes- GSK

The FDA is to lift restrictions on Avandia (rosiglitazone) from GSK and will take actions which include requiring modifications to labelling about cardiovascular safety, requiring changes to the Risk Evaluation and Mitigation Strategy (REMS) program, and releasing a postmarket study requirement. Once the changes are final, rosiglitazone�s indication for use will no longer be limited to certain patients.

The FDA anticipates that the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with Type 2 Diabetes Mellitus, an indication similar to other diabetes drugs currently available. Results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007.

The FDA is also releasing GSK from the postmarket requirement to conduct a clinical trial, known as Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE), comparing Avandia to Actos (pioglitazone).