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FDA acts to remove certain restrictions on diabetes drug

November 26, 2013

The Food and Drug Administration yesterday announced it is removing certain restrictions on the prescribing and use of the diabetes drug Avandia (rosiglitazone) after a study showed no elevated risk of heart attack or death when compared to other standard diabetes drugs. Once associated actions are finalized, including changes to labeling and the Risk Evaluation and Mitigation Strategy program, FDA said health care professionals, pharmacists and patients will no longer be required to enroll in the rosiglitazone REMS program to prescribe, dispense or receive rosiglitazone medicines. The agency also plans to require rosiglitazone manufacturers to ensure that likely prescribers receive updated training on the drug’s cardiovascular risk. In addition to Avandia, rosiglitazone is available in combination with certain other diabetes medications.