In a recent U.S. Food and Drug Administration (FDA) Safety Update, the agency announced that recent data for rosiglitazone-containing drugs, including 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 agency is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on the FDA’s review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI).
Rosiglitazone is an option for treatment of type 2 diabetes, a disease that can lead to serious complications including premature death. Rosiglitazone can improve blood sugar control in some patients with the disease. The FDA suggests that patients with type 2 diabetes continue to work closely with their health care professionals to determine treatment options that are most appropriate.
FDA continues to evaluate the safety and effectiveness of drugs after they go on the market. In the case of rosiglitazone medicines, previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so we required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks.
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 andRegulation of Glycemia in Diabetes (RECORD) trial, the FDA’s concern is substantially reduced and the rosiglitazone REMS program requirements will be modified. The FDA is also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information.
Under FDA’s proposed modifications to the rosiglitazone REMS program:
- Distribution of the medicines 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.
- 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.
- As part of the REMS, sponsors will ensure that health care 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.
