FDA panel votes against label change for naproxen

An FDA advisory committee voted 16-9 Tuesday recommending against changing the label of naproxen-containing therapies. The committee concluded that there was insufficient evidence that naproxen carried a lower risk of cardiovascular thrombotic events than other NSAIDs such as ibuprofen and Pfizer's Celebrex (celecoxib).

The panel meeting was prompted by a meta-analysis of more than 700 studies on NSAIDs, which included more than 350 000 patients and suggested that naproxen was associated with fewer heart problems than other therapies. However, the panellists indicated that the results were difficult to interpret. "Meta-analyses are good for raising questions, not for settling them," remarked panellist Sanjay Kaul.

Despite the apparent "drift" toward fewer heart problems with naproxen, a majority of panellists said the evidence was not conclusive. "If I were forced to bet on what the truth is, my bet would be that naproxen is somewhat safer," commented panellist Susan Ellenberg. Those who voted in favour of naproxen's safety conceded that the evidence is not definitive, but also cited a "duty to inform the public." Panellist Peter Kaboli said "I'm convinced enough to change my own use of NSAIDs to naproxen — and that of my patients — based on what I've heard these last two days."

In response, Bayer, which markets naproxen as Aleve, said it "is pleased" that some panellists agreed that the data are supportive of the medicine's low risk. The company added that a number of the advisory committee members also recommended that treatment guidelines should communicate the differential lower risk of naproxen to other non-aspirin NSAIDs, so that physicians can consider this information as they treat patients.

Commenting on the news, Pfizer said that it agrees with the panel's conclusion that the available data do not confirm a lower cardiovascular risk for naproxen. The drugmaker further said that the ongoing PRECISION study, which is comparing Celebrex to prescription-strength ibuprofen and naproxen in the treatment of arthritis-related pain, could clarify the cardiovascular safety of these therapies.

Meanwhile, the advisory committee did suggest that other updates are needed for the labels of NSAIDs. Specifically, most panellists agreed that warnings about the short-term risk of heart attack and stroke should be included on the labels of these products, as a recent study showed that adverse cardiovascular events can occur within a week of treatment.

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