FDA: No heart advantage with naproxen
In a 16 to 9 vote, committee members did not find enough evidence to put naproxen ahead of other NSAIDs in terms of heart risk.
FDA: No CV advantage with naproxen
HealthDay News -- The science isn't convincing enough to say that naproxen is safer for the heart than other popular nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, two FDA advisory committees ruled Tuesday.
In a 16 to 9 vote, committee members did not find enough evidence to put naproxen ahead of other NSAIDs in terms of heart risk. Those who voted against naproxen said current evidence does not meet the standards necessary to support labeling statements, as much of it was taken indirectly from meta-analyses in which naproxen was used as a comparator for a coxib drug.
In a separate vote on whether the labeling statement on short-term use should be reconsidered, 14 panel members said "Yes" and 11 said "No." Although the current labeling warns that NSAID treatment increases cardiovascular risk, it also specifies that short-term treatment is relatively safe. But recent studies have suggested this may not be the case.
Panelists generally agreed that current language regarding cardiovascular risks on over-the-counter NSAID labels should be clarified, but no consensus was reached on specifics. The FDA isn't required to follow the recommendations of its advisory committees but it usually does so.
Since 2005, labeling laws have required a heart warning on these anti-inflammatory drugs. That warning stemmed from the withdrawal of the NSAID rofecoxib (Vioxx, Merck) from the market in 2004 because of a notable increased risk of heart attack among users.
An FDA panel concluded earlier this month that naproxen didn't seem to carry the same heart risks as the other NSAIDs. That decision was based on a safety review involving 350,000 people using different pain relievers. But, after two days of hearings, the panel ruled that there wasn't enough evidence to state that naproxen was safer for the heart.
"If I were forced to bet on what the truth is, my bet would be that naproxen is somewhat safer," panelist Susan Ellenberg, PhD, of the University of Pennsylvania in Philadelphia, told the Associated Press. "On the other hand, I'm not sure how that relates to our regulatory standard, as there's still a lot of uncertainty here."