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FDA panel says data does not support lower heart risk of naproxen

By Toni Clarke

(Reuters) - 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.

In 2005 the FDA determined that all NSAIDs should carry a warning about cardiovascular risk but said there was no evidence that the drugs carried different levels of risk. While the panel agreed that more information has come to light since then, they are looking to Precision to answer the question once and for all.

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.

One of the key questions in front of the panel was whether to modify the Precision trial, which has been going on for seven years at the request of the FDA. The trial is being funded by Pfizer and run by the Cleveland Clinic.

Dr. Steven Nissen, chairman of the clinic's Department of Cardiovascular Medicine and lead investigator on the Precision study, told the panel the trial has enrolled nearly 27,000 patients, more than 95 percent of the total needed, and that he expects it to be complete around the end of 2015.

Precision is an academically directed trial whose scientific governance resides with an unpaid independent executive committee, Nissen said, and represents the best opportunity to date to answer long-standing questions about the safety of NSAIDs that the FDA has been wrestling with since the withdrawal of Merck & Co.'s Vioxx a decade ago after it was linked to an increased risk of heart attack.

Dr. Garret FitzGerald, director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania who helped craft the meta-analysis published in The Lancet, told the panel that waiting for the Precision results would shed little light on the relative risk of the drugs.

In the end, the panel recommended waiting for Precision and said there should be no modification to the way the trial is being conducted.

(Reporting by Toni Clarke in Washington; Editing by Leslie Adler)

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