An advisory panel to the U.S. Food and Drug Administration said on Tuesday that available evidence does not prove that the painkiller naproxen, sold under the brand names Aleve and Naprosyn, carries a lower cardiac risk than rival products.
The panel was convened after a retrospective analysis from multiple clinical trials published last year in The Lancet suggested naproxen was less dangerous to the heart than other nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen and Celebrex.
Panelists recommended the FDA leave the current product labeling as is, at least pending the outcome of a large ongoing study, known as Precision, that compares naproxen with ibuprofen and Celebrex. The FDA is not bound to follow the advice of its advisory panels, but typically does so.
The FDA's final decision could have wide implications for the way in which these drugs are prescribed and used in the future, and it will have implications for whether the Precision trial is able to continue.
The panel voted 16-9 that while the retrospective combining of results from different studies, known as meta-analysis, hints at a relative benefit for naproxen over other NSAIDs, the data is not reliable and does not warrant changing the prescribing information to reflect a differentiated risk.
"Meta-analyses are good for raising questions but not settling them," said panelist Dr. Sanjay Kaul, a cardiologist and professor at UCLA School of Medicine.
Naprosyn is a prescription product sold by Roche Holding AG, while Aleve is sold over the counter by Bayer AG. Ibuprofen is marketed as Advil by Pfizer Inc and Motrin by Johnson & Johnson. Celebrex is a prescription product made by Pfizer.
Over-the-counter generic versions of both naproxen and ibuprofen are also available.
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