Panel says NSAID labels should not change
An FDA advisory panel said naproxen should not get a heart-friendly label that would indicate it may have a cardiovascular edge over other drugs in its drug class. Medpage Today reports the advisory panel voted 16-9 against a new label, saying there was insufficient evidence to support a change.
The "no" vote does not mean panelists do not think drugs like Aleve may have an edge over other medications. “If I were forced to bet on what the truth is, my bet would be that naproxen is safer,” Susan Ellenberg told the Associated Press.
The panel's decision followed two days of discussions which were prompted by more than 700 studies finding fewer heart problems with OTC and prescribed naproxen compared to other NSAIDs.