FDA MedWatch - Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)

Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)

AUDIENCE: Family Care, Endocrinology, Cardiology

ISSUE: FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.

In 2013, FDA required removal of the prescribing and dispensing restrictions for rosiglitazone medicines after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone medicines compared to the standard type 2 diabetes medicines metformin and sulfonylurea. FDA also required the drug manufacturers to provide educational training to health care professionals about the current state of knowledge regarding the heart risks of rosiglitazone medicines. Manufacturers have since fulfilled these requirements.

FDA has continued monitoring these medicines and identified no new pertinent safety information. FDA will update the public if any new information becomes available.

BACKGROUND: Type 2 diabetes is a disease that can lead to serious complications such as kidney failure, blindness, and premature death. Rosiglitazone can be used along with diet and exercise to control blood sugar in adults with the disease.

RECOMMENDATION: The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm477601.htm