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FDA Advisers: Meta-Analysis Does Not Prove That Naproxen Carries Lower CV Risk — Physician’s First Watch
FDA Advisers: Meta-Analysis Does Not Prove That Naproxen Carries Lower CV Risk
By Amy Orciari Herman
Data from a meta-analysis suggesting that naproxen carries lower cardiovascular risk than other nonsteroidal anti-inflammatory drugs are not reliable, FDA advisers concluded on Tuesday. Consequently, they voted that naproxen should not get a new label based on those data, Reuters reports.
The meta-analysis, published in the Lancet in 2013, found that coxibs or diclofenac conferred increased risk for major vascular events, and ibuprofen showed increased risk for coronary events, relative to placebo. Meanwhile, no such risk increases were seen with naproxen.
The FDA advisers recommended that naproxen's prescribing information stay as is until data from the PRECISION trial are available. That large, randomized trial is comparing naproxen with celecoxib or ibuprofen in patients with osteoarthritis or rheumatoid arthritis.