FDA – Aleve Safer For Heart Than Other Drugs

FDA – Aleve Safer For Heart Than Other Drugs

January 30th, 2014 // 4:14 pm @

FDA state this week that the Aleve pain reliever could be safer for your heart than many other types of anti-inflammatory drugs that millions of Americans take every day.

According to an FDA review that was posted on the FDA website this week, naproxen could have a lower heart attack risk as well as stroke, than many other medications, such as ibuprofen, which is in Advil and Motrin. Naproxen is the drug that is in Aleve.

This safety review was due to a major analysis that was done in 2013 that looked into 350,000 patients who were taking many types of pain relievers. The findings seem to show that naproxen does not have as much of a heart risk as many other drugs in the NSAID class.

FDA released this memo before a public meeting that it is going to hold next month, where experts from outside FDA will talk over the new data and will determine if naproxen needs to be relabeled or not. FDA does not have to follow the advice of such an advisory committee, but it does in most cases.

If these changes are implemented eventually, such a labeling change could involve major changes to the over the counter drug market that is often used to reduce headaches, muscle pains and arthritis.

A change from FDA could make naproxen based drugs the top choice for people who have heart attack risks. But all NSAIDs will continue to have warnings on them about the dangers of internal bleeding, which is a serious side effect that causes as many as 200k hospital visits annually.

This FDA meeting is just the latest chapter in a safety review of NSAID drugs that goes back to 2004. That was when Merck pulled Vioxx from the market because of a link to stroke and heart attack. Vioxx was one of the newer NSAID drugs that were supposed to be easier on the digestive system. But after the recall of Vioxx, FDA started to put stricter warnings about heart risks on NSAID drugs. These include Motrin, Aleve, Advil and Celebrex. Only Celebrex from the same drug class as Vioxx is still being marketed.

FDA also noted this week that it may stop a long term study that has been researching the safety of ibuprofen, naproxen and Celebrex. Recent data show that there is a lower heart attack risk for people who are taking naproxen, so FDA thinks that patients in that trial are being exposed to too much risk.

 

 


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