Charles H. Hennekens, MD, of Florida Atlantic University in Boca Raton, co-authored the meta-analysis in The Lancet. He says he understands that regulators want to wait for direct comparisons of these medications, but he believes from a clinical standpoint the data currently available are clear: some NSAIDs carry a greater risk of cardiovascular side effects, just as others carry a greater risk of gastrointestinal side effects, which he says also needs to be considered for many patients.

“Tailor the particular drug to the particular patient,” Dr. Hennekens says. “Look at the totality of evidence and totality of risk-benefit for that particular patient. Don’t confine it to regulatory considerations on a fine point.”

Questions about the safety of NSAIDs date back to 2004, when the pain reliever rofecoxib (Vioxx) was pulled off the market after increased reports of heart attacks and strokes. A year later the FDA mandated that all NSAIDs carry a warning on their labels of cardiovascular side effects.

By a vote of 14 to 11, the committee also voted that NSAID labeling needs additional changes, since it currently implies that the risk of cardiovascular side effects in the short term is not significant. “We want to be clear that the danger of taking NSAIDs starts on day one. There is no lag period for that,” Miller explains.

“We also wanted to clarify which patients are high risk and need to be especially careful of taking NSAIDs,” he says. Those include patients with existing heart issues, such as heart failure or a history of heart attack, and patients at risk of developing cardiovascular disease in the future.

The FDA does not have to adopt the committee’s recommendations but it usually does so. There is no timetable for a decision on the issues.