According to federal health officials new findings show that Aleve, aka
naproxen sodium, may be a healthier choice for heart health than other
NSAID pain relievers such as ibuprofen. This news could affect millions
of Aleve Pain RelieverAmericans who are concerned about heart health. The FDA posted a
review online on Tuesday that naproxen may have a lower risk of heart
attack and stroke than rival anti-inflammatory drugs.
The FDA released the memo ahead of a meeting next month where a collection of experts will discuss the new data and whether or not naproxen products should be relabeled. The agency is not required to follow the advice provided by this group, but it often does.
Current warning labels on NSAIDS state that long-term use can lead to an
increased risk of heart attack and stroke. Doctors and patients are
advised to limit use to the shortest time possible.
If the labeling changes are made it could mean a multi-million dollar shift in the market that covers pain relievers. As people who are at high risk for cardiac problems or stroke begin choosing naproxen products, other popular NSAID pain relievers such as Advil and Motrin are likely to start losing their market share.
The FDA meeting is the latest part of an ongoing review of the safety of NSAIDS overall. The review reaches all the way back to 2004 when the pain reliever Vioxx was pulled from the market by Merck & Co. Inc. after links to heart attack and stroke were discovered.
In the wake of the Vioxx recall the FDA strengthened the warnings for all drugs in the class, including Motrin, Advil, Aleve and Celebrex. Pfizer's Celebrex is the only drug similar to Vioxx that remains on the market.
The finding of the safety and efficacy of naproxen is based on over 38 years of study in clinical trials, observational studies, and real world use, according to Bayer.
Based on this information, the FDA is also considering ending further trials, citing that they could be exposing the trial participants to undue risk.
Source: ABC News