The Food and Drug Administration (FDA) is rolling back warnings and restrictions on the diabetes drug rosiglitazone (Avandia), after an independent analysis revealed the drug did not increase the risk of heart attacks.
In 2010, the FDA placed restrictions on the use of the drug, manufactured by GlaxoSmithKline, limiting its prescription to physicians in a registry who were educated about the medication’s increased heart risks. Patients also had to acknowledge the risk, and could only use the drug if they had exhausted all other options to control their blood sugar. The decision was based on a review of clinical trials involving the drug published in 2007.
However, this summer, an FDA panel met to discuss and reassess the decision after a new study, called RECORD, found no greater risk for heart disease associated with Avandia than with other diabetes drugs. In a close vote, an FDA advisory panel voted on June 6 to modify the restrictions, and those changes are now being implemented. Out of the 26 FDA panel members, 13 voted to modify the Avandia restrictions, seven voted to remove the restrictions entirely, and five voted to leave the restrictions in place. Only one person voted to remove the drug from the market entirely.
With the new labeling, Avandia will once again be recommended for controlling blood sugar along with a healthy diet and exercise. And patients will now be able to get the drug from their pharmacists rather than special registries.