FDA Panel Votes to Relax Safety Restrictions on Rosiglitazone (Avandia)
New analysis suggests drug may not increase heart attacks (June 6)
An FDA advisory panel has voted to modify safety restrictions on the controversial diabetes drug rosiglitazone (Avandia).
Researchers first raised concerns about possible links to heart attacks in 2007. In 2010 the FDA limited access to the drug, and European regulators banned it. Currently, rosiglitazone is dispensed only by specialty pharmacies, and patients must sign a waiver stating that they understand the drug’s risks before they can get a prescription.
Of the panel’s 26 members, 13 voted to modify the safety restrictions on the drug; seven voted to remove the restrictions; and five voted to keep the measures in place without any changes. One panelist voted to withdraw rosiglitazone from the market entirely.
The panel’s majority decision came after a re-evaluation of the only study that specifically measured rosiglitazone’s heart risks — the RECORD trial, released in 2009.
The vote is a recommendation to the FDA and is not binding.
Regardless of the agency’s final decision, the drug’s manufacturer (GlaxoSmithKine) has said that it has no plans to promote rosiglitazone again.
Sources: Reuters; June 6, 2013; and Associated Press; June 6, 2013.