A nonsteroidal anti-inflammatory drug (NSAID) previously thought to carry heart attack risk is no likelier to do so than are naproxen (Aleve) and ibuprofen (Advil). That’s what a U.S. Food and Drug Administration panel said recently about celecoxib (Celebrex), coming off a 15-5 vote.
The FDA, which doesn’t have to but typically follows its advisory committees’ advice, may make different recommendations about the Pfizer drug to doctors moving forward. “The availability and safety of alternatives to opioid painkillers have become increasingly important as the nation grapples with the deadly epidemic,” NPR reports.
For more than a decade, doctors have hesitated to prescribe celecoxib due to its similarity to two drugs, Vioxx and Bextra, both of which have been pulled from the market for safety reasons, the former in 2004 and the latter in 2005. “Both drugs are known as COX-2 inhibitors, because they act by blocking an enzyme involved in inflammation,” according to NPR.
The FDA findings are based upon a Dec. 2016 study of more than 24,000 osteoarthritis and rheumatoid arthritis patients. Researchers divided the group into three, which took celecoxib, ibuprofen, and naproxen. “At moderate doses, celecoxib was found to be noninferior to ibuprofen or naproxen with regard to cardiovascular safety,” the researchers concluded in that study, published in the New England Journal of Medicine.
A write-up of the recent FDA panel in MedPage quotes people on both sides of the 15-5 vote. Christopher Schmid, of the Brown University School of Public Health, voted yes “with the caveat that this recommendation is limited by the doses and indications in the trial,” according to MedPage, adding that he had “concerns about the design of the study, but I felt the results were strong enough that the comparability of these drugs was probably shown.”
The University of California San Diego’s Neil Farber voted no. “My major concern is the word ‘safety’ and the fact that I don’t think [the trial] proved safety; it perhaps demonstrated non-inferiority but not safety necessarily,” Medpage quotes.