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Wednesday, February 19, 2014

FDA panel votes against changing naproxen heart risk label.

USA Today (2/11, Weise) reported that the painkiller naproxen, sold as Aleve, “does not pose a lower risk of cardiovascular blood clots than other common pain medications such as Advil,” an advisory committee of the FDA voted Tuesday. The advisory panel “reviewed FDA labeling rules that require pain medications known as non-steroidal anti-inflammatory drugs” to carry cardiovascular warning. The panel voted 16-9 “that the available data don’t support a conclusion that naproxen” carried a lower risk of heart risks compared with the other NSAIDs, the article noted.
        The Wall Street Journal (2/12, Burton, Subscription Publication) highlighted the significance of the vote, noting Bayer and others makers of naproxen won’t get any marketing advantage when they offer their medicines on the shelves. The paper noted the FDA had called for the two-day advisory panel meeting because recent medical research seems to suggest that naproxen poses less risk to the heart than other pain relievers.
        The New York Times (2/12, Tavernise, Subscription Publication) and the AP (2/12, Perrone) also cover the story.

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