FDA removes restrictions on Avandia

The FDA has announced the removal of certain restrictions on prescribing and use of a diabetes drug, based on updated cardiovascular data.

The use of rosiglitazone (Avandia, GlaxoSmithKline), a thiazolidinedione indicated as an adjunct to diet and exercise for patients with type 2 diabetes, has been controversial since 2006 when data emerged suggesting a potential risk for CV events, including myocardial infarction and stroke.

However, new results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial demonstrate that there is no elevated risk for MI or death in patients being treated with rosiglitazone compared with standard-of-care diabetes drugs, according to a FDA press release.

“Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions.”

Janet Woodcock

The drug’s indication for use will no longer be restricted to certain patients, and the drug’s new indication will state that it can be used along with diet and exercise to improve glycemic control in patients with type 2 diabetes, according to a press release.

The Risk Evaluation and Mitigation Strategy (REMS) currently in place will be lifted once the changes are finalized, allowing providers to prescribe rosiglitazone without enrollment in a REMS program. Patients will be able to purchase rosiglitazone through regular retail pharmacies and mail-order pharmacies.

In addition, the FDA reports that the manufacturer will no longer need to participate in a postmarket requirement to conduct a clinical trial.

In June, the re-adjudicated results of RECORD were discussed at a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

During the advisory panel meeting, most members agreed that the HRs and CIs from the analyses were consistent and that the drug did not increase risk for all-cause or CV mortality.

Besides Avandia, rosiglitazone is available combined with other diabetes medications, including metformin under the brand name Avandamet and glimepiride under the brand name Avandaryl, according to the release.

For more information:

FDA Drug Safety Communication. Accessed Nov. 25, 2013.

Postmarket drug safety information for patients and providers. Accessed Nov. 25, 2013.