FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines

From FDA - August 1, 2017

Safety Announcement

[11-25-2013] The U.S. Food and Drug Administration (FDA) 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. As a result, we are requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on our 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).

Type 2 diabetes is a disease that can lead to serious complications and premature death. Rosiglitazone is a treatment option that can improve blood sugar control in some patients with the disease. Patients with type 2 diabetes should continue to work closely with their health care professionals to determine treatment options that are most appropriate.

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