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 sufferers that 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 said 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.
"We may very well find that all anti-inflammatories have some kind of cardiac risk," Wilson said. "It may be that we will move to a kind of informed consent. But this study does not show us that."
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. Recently, Pfizer also warned that patients who have had cardiac surgery should not take its other COX-2 inhibitor, Bextra.
The FDA plans to meet in February to discuss the safety of the three COX-2 inhibitors. An FDA spokeswoman said Tuesday she did not know whether Aleve would be added to that list.
''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." ''However, we will keep all regulator options open and make some determinations as quickly as possible based on the data.''
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 halted the study Friday after announcing that 70 of the participants suffered heart attacks or strokes. Twenty-three died.
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 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 a potent fact of pharmacology that many patients and sometimes even their physicians have forgotten or ignored: 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.
Copyright 2004 The Atlanta Journal-Constitution