Panel says NSAID labels should not change

Share this article:

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.

Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Researchers hit links for charity

The PMR Charities Golf Classic teed up more than $20,000 for St. Jude Children's Research Hospital.

FDA to review Neupogen biosimilar

Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.

FDA approves a new painkiller

Targiniq ER combines the prescription opioid oxycodone and naloxone, which is often used to treat overdoses.