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FDA advisers: Data do not support lower CV risk with naproxen
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An FDA panel voted 16-9 to reject a change in naproxen labeling that would reflect lower CV risk compared with other nonsteroidal anti-inflammatory drugs.
During the 2-day meeting, members of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee heard testimony from FDA reviewers, industry representatives and the public on the CV safety of naproxen and other NSAIDs.
"The committee is divided," panel member Tuhina Neogi, MD, PhD, from Boston University School of Medicine, said before the vote. "A number of individuals feel that there are a preponderance of data that show a pattern that naproxen may have lower risk that other nonselective and selective [NSAIDs], and yet others feel that the preponderance of evidence is largely based on observational data which have a number of biases that limit interpretability in terms of its validity."
In September 2004, rofecoxib (Vioxx, Merck) was withdrawn from the market due to increased CV risks. Then, in 2005, the FDA concluded that rofecoxib, valdecoxib and celecoxib (Celebrex, Pfizer) were associated with increased risk for CV events compared with placebo. Valdecoxib was subsequently withdrawn, and a boxed warning was added to all NSAIDs highlighting the potential for CV events and serious gastrointestinal bleeding.
In a 14-11 vote, the committee also recommended reconsidering current NSAID labeling, which implies that CV thrombotic risk is not substantial with short treatment course. The majority were in support based on recent data that suggest risks are not consistent across the drug class.
The ongoing PRECISION trial was also a topic of discussion. The trial was launched in 2006 to evaluate the safety of ibuprofen, naproxen and celecoxib in 22,000 arthritis patients with high CV risk. Despite concerns about trial bias and relevance, the panel recommended no modifications to the trial conduct and await results, which are anticipated in 2015.
The FDA is not required to follow the recommendations of its advisory committees, but usually does. – by Bruce Thiel, with additional reporting by Katie Kalvaitis