FDA Removes REMS From Certain Type-2 Diabetes Medications
The U.S. Food and Drug Administration (FDA) announced on Dec. 16 that it will remove the Risk Evaluation and Mitigation Strategy for type-2 diabetes medications containing rosiglitazone. The Agency states that the indication is “no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.”
The FDA notes that health care professionals and patients should continue to report any adverse events related to rosiglitazone.
Keywords: Diabetes Mellitus, Type 2, Risk Assessment, Thiazolidinediones, United States Food and Drug Administration
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