FDA advisers recommend easing Avandia restrictions

July 15, 2013

FDA advisers recommended in early June the easing of restrictions on the diabetes drug rosiglitazone (Avandia, GlaxoSmithKline), following an independent re-examination of GSK’s RECORD study conducted by Duke Clinical Research Institute.

FDA advisers recommended in early June the easing of restrictions on the diabetes drug rosiglitazone (Avandia, GlaxoSmithKline), following an independent re-examination of GSK’s RECORD study conducted by Duke Clinical Research Institute.

In 2010, FDA limited patient access to the drug after concerns were raised about a possible increased risk of heart attacks connected with its use. In Europe it was banned.

During the latest meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, most of the FDA advisers decided to modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program after the independent study confirmed GSK’s original findings, concluding that the risks of mortality or adverse cardiac outcomes with rosiglitazone used in combination with metformin or sulfonylurea are no different from those connected with the combination treatment of metformin and treatment with sulfonylurea only. However, five FDA advisers voted to keep the current REMS in place, and one adviser wanted to remove the drug from the market.

“We appreciate the committee’s thorough examination of the RECORD results and will continue to work with FDA as it considers the recommendation of the committee,” said Dr. James Shannon, GSK’s chief medical officer. “We continue to believe that [rosiglitazone] is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling.”

The Duke Clinical Research Institute analyzed the RECORD trial data and found the hazard ratio for cardiovascular death, myocardial infarction, and stroke to be 0.95 (95% CI: 0.78-1.17), which is close to the hazard ratio from the original study of 0.93 (95% CI: 0.74-1.15).

FDA will be making its decision, now that the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee have met and voted on the issue.