UPDATED: FDA panel says Aleve should keep its heart-risk warning
Bayer's painkiller Aleve carries the same cardiovascular-risk warning as other nonsteroidal anti-inflammatories, or NSAIDs, like Motrin and Advil. And as far as an FDA review panel of experts is concerned, it should continue to.
The panel voted 16-9 against removing the warning for naproxen (Aleve) on Tuesday, Reuters reports. It said there was insufficient evidence from looking over clinical studies that naproxen should escape that tag, even though an FDA staff report said it found fewer problems for the NSAID. That is the recommendation that it will pass to the FDA.
Dr. Susan Ellenberg of the University of Pennsylvania summed it up this way, according to a report by Fox News. "If I were forced to bet on what the truth is, my bet would be that naproxen is somewhat safer," the panelist said. "On the other hand, I'm not sure how that relates to our regulatory standard, as there's still a lot of uncertainty here."
But many of the panelists thought the evidence was compelling enough for a change. "I'm convinced enough to change my own use of NSAIDs to naproxen--and that of my patients--based on what I've heard these last two days," said Dr. Peter Kaboli of the University of Iowa, according to Fox News.
The experts were looking at the risks of the entire class, which includes Pfizer's ($PFE) prescription drug Celebrex, as well as the ibuprofen products, Motrin made by Johnson & Johnson ($JNJ) and Advil from Pfizer ($PFE). The FDA staff concluded after an analysis of 700 studies of the drugs that narpoxen didn't have the cardiovascular risks of ibuprofen and Celebrex. None of those studies compared the drugs against one another in a single trial, although the Cleveland Clinic is conducting one that does. And Pfizer, which said in a statement that it agreed with the finding, is doing a study comparing naproxen and ibuprofen to Celebrex.
The panel ended up agreeing on a recommendation that would actually stiffen the warning by removing the suggestion that heart risks begin only after 10 days of continuous use. New research from Denmark showed that heart attack and stroke can show up in less than a week of treatment.
Consumers' allegiance to painkillers is a little like people's loyalty to a style of chili. But shedding the warning certainly would provide a selling point that could set a product apart. And while the FDA generally follows the recommendations of its expert panels, it doesn't 100% of the time. That leaves open the possibility that Bayer, and makers of generic naproxen, might still get that benefit.
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