New FDA Review Calls Naproxen Safe for CV System

January 29, 2014

The FDA Advisory Committee responsible for arthritis drugs is considering recent evidence that shows naproxen not to be associated with increased cardiovascular risk, unlike other painkillers in its class. Their recommendations may lead to suspension of a comparative clinical trial and to label changes.

In a briefing document for an Arthritis Advisory Subcommittee meeting scheduled for February 10 and 11, FDA reviewers have urged the Arthritis Advisory Committee to consider recommending changes in the label of the over-the-counter NSAID naproxen, in light of recent evidence of its cardiovascular safety. It is also asked to consider the need for an ongoing clinical trial comparing three COX inhibitors, including naproxen, on the basis of cardiovascular risk.

The review relied heavily on a meta-analysis published in Lancet last August which concluded that naproxen does not have the same increased CV thrombotic risk as the COX inhibitor celecoxib. The authors raised the question whether, in light of this conclusion, the PRECISION study comparing cardiovascular risk between naproxen, ibuprofen, and celecoxib might no longer be ethical or justified.

As well as the possibility of altering or terminating the PRECISION trial, the committee will be considering whether to remove warnings about increased cardiovascular risk from the naproxen product label.

"Currently, the warning statement in NSAID class labeling does not distinguish differential risk across the class," says the briefing document. "However, data from [meta-analyses of randomized controlled trials] suggest that naproxen is not associated with an increased risk of CV thrombotic events."

The committee is also being asked to consider recent evidence that  patients already at high cardiovascular risk who use naproxen or ibuprofen as recommended face no increase in that risk as a result of the drugs.