This article is more than 5 years old. Information may no longer be current.
FDA lifts restrictions on type 2 diabetes drug Avandia
Click Here to Manage Email Alerts
The U.S. Food and Drug Administration said that it is requiring the removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010.The agency said on Nov. 25 that it has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea.The FDA said this decision is based on its review of data from a large, long-term clinical trial and is supported by outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute.
(Combining blood pressure drugs linked to serious side effects in type 2 diabetes patients)
"Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, FDAs concern is substantially reduced and the rosiglitazone REMS program requirements will be modified," the FDA said in a news release.
The agency is also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information. Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense or receive rosiglitazone medicines.