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Doctors caution Aleve users not to feel panicked

By VIRGINIA ANDERSON
The Atlanta Journal-Constitution
Published on: 12/22/04

Stunning news that a fourth popular painkiller may increase the risk of heart attack or stroke added anxiety Tuesday for patients already worried about the safety of the drugs.

This time, it was Aleve, an over-the-counter pain medicine popular with arthritis sufferersthat is also used to treat maladies ranging from headaches to sports injuries. It was the fourth time in three months and the second time in days that a popular painkiller was linked to increased risk for heart attack or stroke.

Doctors said Tuesday, however, that the findings about Aleve, or naproxen, may not have the broad applications that many patients fear.

"All of this is very scary to patients, but there is no need for panic," said Dr. Hayes Wilson, an Atlanta rheumatologist.

Patients who take Aleve short-term, as directed, and who have no known risk of heart disease should have no reason to worry, doctors said.

About 70 million Americans suffer from arthritis. Many turn to nonsteroidal anti-inflammatory drugs, or NSAIDs, such as Aleve. Many of the drugs, however, cause stomach problems, including bleeding. A subset of the NSAIDs, called COX-2 inhibitors, brought great hope to arthritis sufferers because they don't cause the stomach problems.

Federal officials allowed that further research could show that the entire class of NSAIDs, including Advil and Mobic, could cause problems for the heart.

Those problems may not put most patients at higher risk for heart attack or stroke. Millions have taken Aleve in its 28-year history without noticeable side effects.

In recent weeks, three COX-2 inhibitors have come under increased scrutiny. Merck & Co. pulled Vioxx off the market in September after studies showed an increased risk of heart attack and stroke. It accounted for $2 billion in sales in 2003. Last week, Pfizer, maker of Celebrex, stopped its ads after links were found to the same risks. Pfizer also warned that patients who have had cardiac surgery should not take its Bextra.

The FDA plans to meet in February to discuss the safety of the three COX-2 inhibitors.

"It would be premature to say what we're going to do with either one of these drugs, Celebrex or Aleve," said Lester Crawford, acting commissioner of the Food and Drug Administration, on NBC's "Today."

Crawford said that patients concerned about Aleve should follow the dosage recommendations for the drugs.

Bayer HealthCare, which makes Aleve, said Tuesday it has not seen the research data but plans to cooperate with federal authorities.

"In the meantime, we are in agreement with the FDA's recommendations that Aleve can be used safely as directed for pain relief and that consumers should not take the product for longer than 10 days unless directed to do so by a physician," the company said.

Sales of Aleve were $148 billion last year, according to a Dec. 20 report from Brand Week.

The Aleve study, by the National Institutes of Health, was looking at whether Aleve and Celebrex could delay onset of Alzheimer's disease. It involved 2,400 volunteers age 70 and older.

Investigators estimate a 50 percent increase in heart attacks or strokes among study participants taking Aleve, compared with those who had been taking placebos.

Patients in the study were given 220 milligrams of Aleve twice a day, the same dose recommended for over-the-counter use.

Because the patients were older and had been taking Aleve for much longer than the recommended time, doctors on Tuesday said it would be inaccurate to apply the findings from the Alzheimer's study to the general population.

Doctors said the latest news underscores that drugs of all kinds come with consequences.

"Every single medicine, really every single thing you put into your body has a potential side effect," said Dr. Laurence Sperling, director of preventive cardiology at Emory School of Medicine.

People with heart problems or those at risk of heart disease probably should avoid taking the COX-2 inhibitors, Sperling said.

"If you're going to take an over-the-counter medicine, read the label, read the fine print and follow the guide," Sperling said.

— News services contributed to this article.

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Actually, Aleve is naproxen, a nonsteroidal anti-inflammatory in the propionic acid group, which is also the group that ibuprofen (Advil, Motrin) belongs to. The propionic acid group of anti-inflammatories have been around for a long time, and are known for their lower toxicity. But you are on the right track, in that Aleve and Motrin are both nonselective COX enzyme inhibitors, which means they do not promote blood clot formation in the body, as all COX-2 selective inhibitors (Vioxx, Celebrex, Bextra) DO. This is a known fact and based on straightforward easily understodd chemistry. The nonselective COX enzyme inhibitors do not have any known mechanisms whereas they would promote clots, but the COX-2 inhibitors DO, and this was known by the pharmaceutical companies, but they ignored it and put the medicine out, after bribing the FDAwith sufficient "application fees."
The senseless NIH study was thrown out by the government, Pfizer, and Merck to distract the public and draw attention away from the fact that they had allowed drugs known to promote blood clots to be marketed. Statistics connecting elderly patients taking doses of Aleve with increased heart attacks mean nothing, just as statistics linking lightning with grass growth mean nothing. Just as the rain is the true cause for grass growth, unsupervised dosing of Aleve (dose levels?) could lead to increased fluid retention and increased blood pressure, both of which could lead to increased heart attacks if not easily treated with diuretics and antihypertensives.

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They warn you on cold remedies if you have high blood pressure to not take some . Yet Aleve and Motrin say nothing.

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