FDA Panel Sees No Heart-Safety 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, US health advisers ruled Tuesday.
The decision was highly anticipated, since a vote in favor of naproxen's superiority might have led to a product labeling change, experts said. However, the 16 to 9 vote by the advisory panel to the US Food and Drug Administration did not find enough evidence to put naproxen ahead of other NSAIDs in terms of heart risk. 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 Merck's withdrawal of the NSAID Vioxx from the market in 2004 because of a notable increased risk of heart attack among Vioxx 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 the FDA advisory committee decided Tuesday, after two days of hearings, 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."