FDA Panel Addresses Painkiller Cardiac Safety Labels This Week

A panel of drug experts is expected to weigh in on whether painkiller drugs like Advil, Aleve and Celebrex may pose a greater cardiac risk.

A joint meeting of the FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee is expected to convene later this week, to address topics focusing on the safety and cardiac risk of popular nonsteroidal anti-inflammatory drugs (NSAIDs).

Popular NSAIDS like Aleve, Advil, Motrin and the prescription drug Celebrex are often used to aid with joint pain, arthritis and inflammation. These drugs, used by millions, are currently required to have a warning concerning heart risk.

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The FDA committee is expected to reach a recommendation which could exempt Aleve from the heart risk warning label requirement on the packaging.

The concerns regarding heart risk emerged in 2004, after the prescription medication Vioxx was pulled from the market amid findings that the drug increases the risk of heart attacks. Then in 2005, the FDA then required all NSAIDs to carry the heart warning on the labeling, without differentiating between specific brands of the pain medications.

Painkillers are often taken amidst concern of cardiac risk, since many patients who take the drugs are older and have heart disease. Many experts have attested that Aleve is among the safest in the NSAID category, especially in comparison to other NSAIDs like Advil and Motrin.

Dr. Andrew D. Mosholder, an FDA epidemiologist, offered an analysis in November 2013, after conducting a meta-analysis of more than 700 studies. He concluded that no vascular risk was associated with Aleve but the risks of Celebrex and ibuprofen were comparable.

Other experts are expected to offer similar recommendations, however the first full head-to-head study of NSAIDs, called Precision, is being conducted at the Cleveland Clinic. It is nearly a year away from offering a full recommendation.

The study is examining more than 20,000 patients randomly assigned to various NSAIDs to determine the cardiovascular risk.

Aleve Could Gain Market Advantage

Last year, the medical journal The Lancet published a study that revealed NSAIDs like Advil and Motrin may increase the chances of suffering heart problems, including death. The research revealed patients who took high doses of NSAIDs had a 33% greater risk of suffering a heart attack, stroke or early death. The findings are in line with much of the concerns surrounding the use of NSAIDs, however did not apply to Aleve.

Pfizer, maker of Celebrex and Advil, and Johnson & Johnson, maker of Motrin, are calling for the current labeling to continue, and to keep all NSAIDs at similar marketing standards. Exempting Aleve from the cardiac risk warning label requirements would likely give the medication a significant marketing advantage.

The class of drugs also includes aspirin, however the panel is less focused on the effects of aspirin since it is often associated with heart benefits at low doses.

The committee is also placing greater focus on the prescription versions of NSAIDS, like Celebrex, which are often taken in larger doses than over-the-counter.

The FDA is not required to follow the recommendation of the advisory panel, however it often does adhere to the recommendations. The committee will vote Tuesday. The FDA will give the final decision later this year.


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