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The FDA is doing away with the Risk Evaluation and Mitigation Strategy (REMS) for the type 2 diabetes medication that contain rosiglitazone (Avandia).
The REMS was "no longer necessary to ensure that the benefits" of the drug outweigh its risks, on its website today. The drug has been under scrutiny since 2007, when a meta-analysis found that rosiglitazone was linked to risk of myocardial infarction.
But the FDA began to loosen restrictions on the drug 2 years ago when it required removal of prescribing and dispensing restrictions after it determined that there was no increased risk of heart attack with rosiglitazone compared to other type 2 diabetes medications like metformin or sulfonylurea. The agency also required that the manufacturers of the drug provide educational training to doctors and other healthcare professionals for rosiglitazone.
"Manufacturers have since fulfilled these requirements," wrote the agency. No new safety information has come to light in the time since then, it added.
The drug was approved by the FDA in 1999. It was withdrawn from the U.K. market in 2010 over concerns that the benefits didn't outweigh the risks.
The FDA's decision in 2013 to lighten restrictions came under some criticism at the time. The RECORD trial from which the outcomes data came was the drug's only large randomized trial, but it was poorly designed, according to critics. The FDA called for re-adjudication of the RECORD data, and in June of 2013 an FDA advisory committee concluded that the restrictions could be relaxed, which the agency formalized in November of that year.
When the FDA made its decision in 2013, many experts said that there would be little, if any, impact on prescribing in the US, since there are newer classes of medications that clinicians are more likely to use. In an email to 鶹ý, , at the University of Glasgow, echoed this sentiment.
"I think it is a fair decision, given that more recent evidence does not confirm a clear cut higher risk for CVD for this medication,” he wrote. “Having said this, the damage has been done and when doctors (worldwide) wish to use a glitazone for their patients, which is also less common now, they will chose pioglitazone. So this decision will make little material difference."
Rosiglitazone is also contained in combination products Avandamet and Avandaryl, and in generic medications. The FDA noted that it will update the public if new information becomes available, and asked healthcare professionals and patients to report adverse events associated with rosiglitazone to their and Adverse Event Reporting Program.