FDA advisory committees vote against changing naproxen label to highlight a lower CVD profile


SILVER SPRING, Md. — After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports. 

Those advisory panels who voted against the change felt the data were insufficient to say naproxen was safer than other NSAIDs.

"While the Advisory Committee panel did not find the accumulated data supported a significant difference in cardiovascular risk for naproxen, as compared to other non-aspirin NSAIDs, Bayer HealthCare is pleased that a number of the Advisory Committee panelists agreed that the data are supportive of its low risk, and that there is a large body of evidence that consistently demonstrates that naproxen has a low CV thrombotic risk compared to other non-aspirin, non-steroidal anti-inflammatory drugs," Bayer stated following the vote. "Further, a number of the panelists recommended that treatment guidelines and other information for healthcare professionals and their patients should communicate the differential lower risk of naproxen to other non-aspirin NSAIDs, so that physicians can consider this information as they treat patients." 

The issue of heightened risk of cardivascular disease associated with NSAID use was raised nearly 10 years ago when Merck's Vioxx was pulled from the market for that reason. The prescription NSAID Bextra also was withdrawn from the market while a black box warning was added to all remaining NSAIDs regarding the increased CVD risk profile. There currently is a study, titled "Precision," that is evaluating the relative safety of the prescription remedy Celebrex and OTC NSAIDs ibuprofen and naproxen. 

The Consumer Healthcare Products Association noted use of OTC NSAIDs to relieve short-term pain and reduce fever "have a long history of safety and efficacy when used as directed."

“It is important to distinguish the use and safety of OTC NSAIDs from that of long-term and/or high-dose prescription NSAID use," the association noted. "OTC NSAIDs, including ibuprofen and naproxen sodium, differ from prescription NSAIDs in indication, dose and duration of use. OTC NSAIDs have a wider margin of safety because they are for short-term use at lower doses for acute pain/fever conditions and are not intended to be used on a chronic basis unless directed by a physician."

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