Painkiller naproxen safe for heart: study

By Maggie Fox

WASHINGTON (Reuters) - Naproxen, a common, over-the-counter pain reliever used for arthritis and other aches and pains, appears to be safe for the heart, despite warnings, researchers reported on Saturday.

A study of 41 healthy men and women showed naproxen, sold under the brand name Aleve by Bayer Consumer Care, "thins" the blood in much the same way as aspirin does.

This anti-clotting effect is seen on platelets, which are cells in the blood that help make clots.

Dr. Michael Schiff of the Denver Arthritis Clinic and Dr. Marc Hochberg of the University of Maryland School of Medicine studied the blood of 41 volunteers who took Aleve once or twice a day for a week, compared to a placebo and then compared to 81 mg low-dose aspirin.

The prescription dose of naproxen had already been shown to reduce platelet activity but this was the first test with over-the-counter doses.

The researchers measured a compound in the blood called serum thromboxane B2 and found that naproxen had similar effects to that of coated aspirin.

"This is good news. It is reassuring news," Schiff said in a telephone interview.

"These data, confirming that the over-the-counter dose of naproxen sodium has a measurable antiplatelet effect, add to the body of evidence about the safety of this compound," added Hochberg.

Naproxen is in a class of drugs called non-steroidal anti-inflammatory drugs, or NSAIDS.

In 2004, the Food and Drug Administration asked the makers of ibuprofen, naproxen and ketoprofen to add labeling with more warnings about gastrointestinal and heart risks of the drugs, and advising patients to take them only for a limited time.

This came after some drugs from a new class of drugs called COX-2 inhibitors were found to raise the risk of heart attacks and strokes.

The COX-2 inhibitors were ironically designed to be safer alternatives to aspirin, ibuprofen and other NSAIDs, which can cause sometimes fatal stomach bleeding.

Merck and Co. withdrew its arthritis drug Vioxx from the market in September 2004. It is facing more than 11,500 product liability lawsuits from people claiming to have been harmed by Vioxx.

Other studies then suggested naproxen might also be dangerous, although many experts have questioned this.

"We know from very large epidemiological (population) studies and all sorts of studies that naproxen is a safe drug, perhaps the best of the NSAIDS," said Dr. Steve Nissen of the Cleveland Clinic Foundation.

Nissen is currently testing 21,000 patients to compare the safety of naproxen, aspirin and another COX-2 inhibitor, Pfizer's Celebrex, known generically as celecoxib.