The FDA made the decision on the recommendation of an expert advisory panel that was convened following the Lancet’s publication of a retrospective analysis of multiple clinical trials (2013) which suggested naproxen was less dangerous to the heart than other NSAIDs.
The advisory panel said that available evidence does not prove that the painkiller naproxen, sold under the brand names Aleve and Naprosyn, carries a lower cardiac risk than rival products, Reuters.com reported. They advised the FDA to allow the Precision study, being led by Dr. Steven Nissen, chairman of the Cleveland Clinic’s Department of Cardiovascular Medicine and lead investigator on the Precision study, to finish. Precision has so far enrolled nearly 27,000 patients, more than 95 percent of the total needed, and is expected to be complete towards the end of 2015.
Precision has been underway for seven years and represents the best opportunity to date to answer long-standing questions about the safety of NSAIDs. The issue of cardiovascular safety associated with NSAIDs has been an issue for the FDA since Merck & Co.'s Vioxx was taken off the market when it was found to increase the risk for heart attack.
In 2005 the FDA determined that all NSAIDs should carry a warning for cardiovascular risk, but the evidence was lacking. NSAIDs include Naprosyn, which requires a prescription and is made by Roche Holding AG, Bayer’s Aleve, ibuprofen marketed as Pfizer’s Advil, and Johnson and Johnson’s Motrin. Celebrex, also made by Pfizer, requires a prescription. Over-the-counter generic versions of both naproxen and ibuprofen are also available.
The advisory panel stated they are looking to the Precision study to provide definitive answers to the question of cardiovascular safety with these drugs.