FDA Panel Votes Naproxen Not Safer Than Other NSAIDS
By Cyndi Root
Food and Drug Administration (FDA) committee members voted to leave in place heart risk warnings for Naproxen. The decision comes as somewhat of a surprise as the briefing document for the advisory meeting discussed Aleve/Naproxen and evidence suggested that the drug has a lower risk for cardiovascular (CV) events than other nonsteroidal anti-inflammatory drugs (NSAIDs). Evidence that the panel reviewed was considered observational or indirect, which one investigator said is beneficial for clinical questioning but does not help in settling questions. Some panelists found the evidence convincing enough, but others found the evidence inconclusive.
Naproxen History
In 1976, the FDA approved naproxen and it is available now in over 50 countries. Consumers can purchase generics or name brands like Aleve. It is available by prescription or over-the-counter (OTC). The FDA changed the label on all NSAIDS in 2005. The label changes reflected the FDA’s concerns about cardiovascular risks, as well as gastrointestinal (GI) bleeding and allergic skin reactions. Manufacturers Bayer and Roche submitted evidence in 2005 that its product had a low risk for cardiovascular problems.
The evidence for this claim was the 1,000,000 people who participated in clinical trials and post-marketing studies and showed no CV events. Additionally, the studies showed that naproxen may have cardio-protective qualities. In preparation for the committee meeting, members reviewed data, studies, and other evidence since 2005. Included for review were clinical studies, meta-analysis of studies, and pharmocovigilence studies.
The Committee Vote
Industry insiders consider the vote to be counter to the briefing document, where it seemed clear that the FDA would change the naproxen label. The 16–9 vote reflected the committee’s reluctance to overturn the decision in 2005 to warn consumers of possible heart risks. After two days of hearings, members decided that there just was not enough evidence to make a big change in the drug’s profile or to the warning label.
Dr. Susan Ellenberg, panelist from the University of Pennsylvania, said, "If I were forced to bet on what the truth is, my bet would be that naproxen is somewhat safer." She added that due to regulatory standards, uncertainty about the drug and its side effects made changing the label difficult. Some panelists have publicly said that the evidence was convincing enough for them to change their opinion about the drug and that they intend to prescribe it more.