FDA: Naproxen doesn’t lower risk for heart disease

An FDA advisory panel recently met and decided that Naproxen does not appear to lower the risk of heart attack and stroke compared to other drugs.

Medical research shows that the pain reliever, Naproxen, poses less risk to the heart compared to other pain medications.  On Tuesday, however, an FDA appointed panel voted 16 to 9, saying there isn’t enough evidence support the claim.  The pain medication, sold as Aleve, does not lower the risk of cardiovascular blood clots any more than similar pain medications.

The panel reviewed FDA labeling rules and regulations, which require that pain medications, known as non-steroidal anti-inflammatory drugs (NSAIDs), to include a heart warning on the label.  Pain killers like Aleve and Advil are taken by millions of people every day.  Although research has found a link between pain killers and “cardiac events”, the panel decided that the available date doesn’t support the claim that naproxen provides a lower risk of cardiac problems for patients.

“When you say cardiovascular risk, are you talking about stroke risk, about increases in blood pressure?  Such a wide range of issues can happen with the heart, it’s kind of tricky to determine.”  Said Victoria Richards, professor of medicine at Quinnipiac University School of Medicine in North Haven, Conn.

Doctors have been hesitant about patients taking pain killers over the counter.  Though individual pills contain low doses, patients who take enough of them could still develop cardiovascular side effects.

“There are concerning signals of the risk of an increased rate of heart attack and stroke in patients who have cardiovascular disease or might be at risk for developing cardiovascular disease, when they take non-steroidal anti-inflammatory drugs.”  Said Elliot Antman, president-elect of the American Heart Association.

Because of the link between NSAIDs and cardiovascular problems, doctors recommend that patients who suffer from cardiac problems should tell their doctors if they’re taking pain medication, even if it is over the counter.

“All too often, patients just list the drugs for which they have prescriptions, but all the drugs they take are important for us to know about.” Said Antman.

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