FDA Eliminates Risk Plan For Avandia Diabetes Drugs; Risks Don’t Outweigh Benefits

(December 17, 2015, 2:14 PM EST) -- SILVER SPRING, Md. — The Food and Drug Administration on Dec. 16 said it is eliminating the risk evaluation and mitigation strategy (REMS) for type 2 diabetes medicines that contain rosiglitazone, known as Avandia.

“The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks,” the FDA said in a drug safety announcement

The elimination of the REMS follows the 2013 removal of prescribing and dispensing restrictions for Avandia after the agency determined that data did not demonstrate an increased...
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