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FDA Removes Restrictions on Diabetes Drug Rosiglitazone (Avandia)

No evidence for increased risk of heart attack (November 25)

The FDA has announced that it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug rosiglitazone (Avandia) to reflect new information regarding the drug’s cardiovascular risk.

Results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial showed no elevated risk of heart attack or death in patients treated with rosiglitazone compared with those given standard-of-care diabetes drugs. According to the FDA, 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 agency’s actions include requiring modifications to labeling about cardiovascular safety; requiring changes to the Risk Evaluation and Mitigation Strategy (REMS) program; and releasing the drug’s manufacturer (GlaxoSmithKline) from a requirement to conduct a postmarketing study comparing rosiglitazone with pioglitazone (Actos, Takeda Pharmaceuticals).

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 the control of blood sugar in patients with type-2 diabetes mellitus, an indication similar to that of other diabetes drugs currently available.

Moreover, once the changes to the REMS are finalized, health care professionals, pharmacists, and patients will no longer be required to enroll in the rosiglitazone REMS program to prescribe, dispense, or receive rosiglitazone medicines. Patients will also be able to receive rosiglitazone through regular retail pharmacies and mail-order pharmacies.

In addition to Avandia, rosiglitazone is available in combination with other diabetes medications, including metformin under the brand name Avandamet and glimepiride under the brand name Avandaryl (both marketed by GlaxoSmithKline).

Source: FDA; November 25, 2013.

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