Aleve Heart Risk Warnings Should Be Kept, FDA Panel Says

In a move that came as a surprise to some, an FDA advisory panel indicated this week that the painkiller Aleve should continue to carry warnings about the potential for heart problems. 

During a two-day meeting of the FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which convened earlier this week, health experts voted 16–9 to recommend against removing the heart warning for Aleve and the prescription version Naprosyn.

Initially, the special advisory panel was expected to vote in favor of removing the warning for Aleve heart risks, after an analysis of health data for nonsteroidal anti-inflammatory drugs (NSAIDs)suggested that Aleve may not carry the same risk as other similar painkillers, including Advil, Motrin, Celebrex, Vioxx and others.

Following a review of the available data, a majority of the panel said they did not see evidence indicating Aleve has lower cardiovascular risk than other NSAIDs.

Popular NSAIDs like Aleve, Advil and Motrin are often used to treat inflammation, arthritis and joint pain. Used by millions of people across the country, all medications that are part of this class of drugs are currently required to have a warning about the potential cardiovascular risk.

Concerns regarding heart risks with NSAID painkillers emerged in 2004, after the prescription medication Vioxx was recalled from the market amid findings that it may increase the risk of heart attacks. In 2005, the FDA required all NSAIDs add a warning to their label detailing the cardiovascular risk.

The advisory panel vote on Tuesday was widely expected to recommend that the warning be removed for Aleve, which would have given the medication a substantial market advantage. However, the independent panel of experts found that there is insufficient evidence from clinical studies that Aleve should not carry that warning as well as the other brands.

Dr. Andrew Mosholder, and FDA epidemiologist, offered a meta-analysis of 700 different studies, concluding Aleve was among the safest in the NSAID category. However, a full clinical trial that pairs the NSAID medications head-to-head using more than 27,000 participants is more than a year from completion. The results from the Precision study, being conducted at the Cleveland Clinic, is largely what many panelists are waiting on before offering a recommendation as to the safety of NSAIDs.

Other studies have focused on the safety of NSAIDs, but not to the degree and depth of the Precision study.

Research published last year in the journal The Lancet found NSAIDs like Advil and Motrin may increase the risk of heart problems, while suggesting Aleve may be much safer.

The committee also agreed on a recommendation to stiffen the warning for NSAIDs, by removing the suggestion that heart risk may only begin after 10 days of continuous use. This was based on a new study from Denmark which found heart attack and stroke can surface within less than a week of treatment with NSAIDs.

The committee will offer the recommendation to the FDA to keep the heart warning on the Aleve label.

While the FDA is not required to adhere to the committee’s recommendation, typically the agency does follow it, but has also been known deviated from such recommendations in the past.