Naproxen Does Not Reduce Heart Disease Risk, Says FDA


Naproxen, or the sodium salt more commonly known as Aleve, does not reduce the risk of heart disease after all, a medical panel appointed by the FDA says. Naproxen is often sold as a a pain reliever for stiff muscles, sever pain, fevers, and inflammation caused by a variety of factors and/or illnesses. It is believed by many medical experts that Naproxen has a significantly lower risk of causing heart problems than other pain medications, such as Ibuprofen, and many studies and researchers have attempted to prove this. Recently, based on research findings, a panel was set up by the Food and Drug Administration to see if the label should be changed on Naproxen, (Aleve), to recommend a lower risk of heart problems than other pain reducing drugs.

A medical panel set up by the Food and Drug Administration, which gathered this past Tuesday, reviewed the issue and found that the FDA regulations for labels on non-steroidal anti-inflammatory drugs (NSAIDs), says that it is mandatory that they all have a heart risk warning. The FDA medical panel says that Naproxen does not reduce heart disease risk, and concluded that there is not yet enough evidence to place a label on Naproxen recommending it over other medications. Because of this, they voted 16-9 that the research available on Naproxen and the risk of heart problems does not confirm enough evidence that Naproxen is safer that all of the other non-steroidal anti-inflammatory drugs.

In recent years, researchers have found correlations between popular pain medications and heart issues. These medications, such as Aleve, Ibuprofen, and Advil, are taken by millions of people, specifically Americans, every day. The American Heart Association said in 2007 that Americans and their doctors should be sure to take care when choosing a pain medication, and always pick the one with the lowest risk of heart issues. Doctors say people should always take it for the shortest length of time possible, and always take the lowest dosage necessary in order for the medication to still have its proper effects. The panel also voted 14-11 that the wording of the labels on the NSAIDs should be changed, as it is implied presently that when the drugs are taken for short periods of time, they run little to no risk of heart problems.

Some doctors and researchers also recommended a change on labels for Naproxen, recommending it over Ibuprofen for those with heart problems, but this was shot down by the FDA’s medical panel. Since the Food and Drug Administration’s panel convened and ruled that Naproxen carries no lesser risk for heart problems, they disagreed.

Concern has also risen among doctors about these prescriptions being sold over the counter and being taken without proper doctor supervision. Although the pills taken separately contain a low dosage, too much taken at once can be detrimental to a person’s health, especially a person who runs a high risk for heart issues.

Bayer HealthCare, the manufacturer of Aleve, says it is glad so many of the panelists agree with it about supportive data regarding Naproxen, even though the the FDA medical panel itself ultimately says that Naproxen does not reduce heart disease risk.

By Laura Clark

USA Today
ABC News

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