Naproxen Loses FDA Advisory Panel Vote

naproxenA FDA advisory panel vote resulted in 16 to nine against naproxen as a better choice than ibuprofen and other pain relievers in terms of heart health. Naproxen, more commonly known as Aleve, is a non-steroidal anti-inflammatory drug (NSAID.) After endorsements earlier this year, naproxen loses the votes and the review prompts revised labeling on the bottles.

The advisory panel scheduled to convene for two days, where they spent time going over evidence in an effort to settle the debate that has been waged for over a decade. They compared naproxen to other anti-inflammatory drugs, including Advil and generic versions of ibuprofen to find out which was better for the heart. The majority of the panel did not find sufficient evidence to declare naproxen a winner though. They are advising the public not to switch pain reliever medicines from ibuprofen to naproxen at this time.

The main concern was over heart health. Naproxen was not deemed safer than the other pain relievers. In fact, they discovered the need to update the current package labels that warn about the side effects of naproxen when taken consistently for more than 10 days. The research and studies they reviewed indicated a shorter time period in which naproxen increased the risk for heart attacks and stroke, and that was within seven days. The second vote that took place regarding the labels ended in a 14 to 11 count, with more experts in favor of changing how the label is worded.

Advice from the panel is not consistent with the information previously given about the safety of naproxen. For example, a 2007 statement from the American Heart Association said that physicians should advise patients to use pain relievers with the lowest risk. At that time Aleve, made by Bayer, was viewed as the safest product on the market. Naproxen is used to treat the pain and inflammation associated with rheumatoid arthritis, psonatic arthritis, gout, kidney stones and tendonitis. It was initially approved as an over-the counter drug by the FDA in 1994, although it is only available by prescription in some other countries.

Additionally, a 2013 meta-analysis by Dr. Neeraj Bhala from Oxford University U.K. did not find the same answer as the advisory panel. The results of the review were published in Lancet and it concluded that NSAIDs have a lower risk than other pain relievers. Bhala and his team used information from 753 trials, including comparisons against placebos. They found that naproxen shows a lowered cardiovascular risk than other pain relievers, claiming that the benefits of taking Aleve and generic brands of naproxen outweigh the risks.

The FDA will consider the decision of the advisory panel and the vote that resulted from their meeting, but they are the ones to make the final decision about the safety of naproxen. They will also consider the idea of changing the wording on the label of Aleve to reflect a risk of heart attack associated with a shorter period of continued use. The main reason experts gave for not choosing naproxen as the safer medicine was a lack of evidence.

By Tracy Rose


Wall Street Journal

ABC News


Science Daily


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