FDA dials back safety restrictions on Avandia
The FDA said it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Its actions are consistent with the recommendations of expert advisory committees.
“Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug,” said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. “Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions.”
The agency had placed restrictions on the med following a two-year Senate inquiry, results of which were released in 2010.