The FDA is requiring the removal of prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010.
This decision was based on the FDA’s review of data from a large, long-term clinical trial and is supported by a re-evaluation of the data by the Duke Clinical Research Institute (DCRI).
Recent data for rosiglitazone-containing drugs (Avandia, Avandamet, Avandaryl, and generics) do not demonstrate an increased risk of heart attack compared to the standard type 2 diabetes medications metformin and sulfonylurea.
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, the rosiglitazone REMS program requirements will be modified as well as the prescribing information and the patient Medication Guide.
Under the FDA’s proposed modifications to the rosiglitazone REMS program:
- Distribution of the drugs will no longer be restricted. Rosiglitazone may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus.
- Healthcare 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.
- As part of the REMS, sponsors will ensure that healthcare professionals who are likely to prescribe rosiglitazone medicines are provided training based on the current state of knowledge concerning the cardiovascular risk of rosiglitazone medicines. Manufacturers will also send Dear Healthcare Provider and Dear Professional Society letters to educate prescribers about the new information.
For more information call (800) 741-8138 or visit the FDA website.