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Experts say users of painkiller mentioned in recent heart study shouldn't panic

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Dec. 22--People should not automatically stop taking certain painkillers because of warnings about heart attacks and strokes, physicians said yesterday -- a day after a fourth popular anti-inflammatory drug was linked to such problems.

Patients should decide with their doctors if a drug's benefit outweighs the risks. A patient's existing risk of heart attack or stroke, the amount of pain he or she suffers, and any stomach problems associated with the drug should all be considered before using any of the pain medications, doctors said.

"Patients don't need to panic," said Dr. Greg Gardner, a University of Washington specialist in arthritis. Recent research that found an association between the drugs and heart problems, stroke or both "doesn't mean there is cause and effect," he said.

The pain medications Vioxx, Celebrex, Bextra -- all so-called COX-2 inhibitors -- and Aleve all have been linked recently to an increased risk of cardiovascular problems.

The National Institutes of Health halted a study involving naproxen, sold over the counter as Aleve, on Monday.

The increased risks were found during studies testing the effectiveness of the drugs to treat illnesses not directly related to cardiovascular disease.

COX-2 inhibitors are marketed as providing pain relief, particularly for arthritis sufferers, without causing the stomach problems associated with other common pain relievers.

Four popular painkillers have been linked to cardiovascular problems. Doctors say much more study is needed to determine the real risks.

OFF THE MARKET: Drug company Merck withdrew Vioxx from the market Sept. 30 after a study indicated it doubled the risk of heart attack and stroke among those who took it for longer than 18 months. Vioxx is in a class of drugs called COX-2 inhibitors that relieve pain without causing stomach problems associated with anti-inflammatory medicines.

WARNING ISSUED: The Food and Drug Administration on Dec. 9 warned that a study involving Bextra, another COX-2 inhibitor, indicated the drug increased the risk of heart attack among patients who had heart surgery.

WARNING ISSUED: The FDA on Friday warned about Celebrex, the third big COX-2 inhibitor, after a study reported that people given high doses had increased heart problems. The FDA asked drug maker Pfizer to stop advertising the drug.

STUDY HALTED: The National Institutes of Health on Monday halted a study of the anti-inflammatory drug naproxen, sold over the counter as Aleve, after preliminary results showed increased risks of heart attacks and strokes in patients taking the drug. The study was testing whether naproxen and Celebrex could help prevent Alzheimer's.

Gardner and Dr. Philip Mease, a rheumatologist associated with Swedish Medical Center, said much more study is needed before seriously questioning the use of all nonsteroidal anti-inflammatory drugs, as some researchers have done since the findings.

"You can't make any blanket statements about the drugs," Mease said. "People have different risks for cardiovascular disease and gastrointestinal problems, different levels of pain, different types of arthritis and different use of other medications."

New studies should take into consideration patients' existing risks for heart attacks and stroke, the doctors said, including age, family or patient history of cardiovascular disease, and high blood pressure and cholesterol.

Gardner said he especially would not recommend his patients stop taking Aleve, as long as their blood pressure is not high.

He cited a recent case study that reported an 11 percent decreased risk of heart attack in patients who took naproxen, or Aleve. The study was reported in the medical journal Circulation and involved 25,000 patients.

Mease said he will join a panel of researchers and federal Food and Drug Administration officials in January in reviewing findings about nonsteroidal anti-inflammatory drugs and cardiovascular risks. The group will design a large, long-term study of risks.

The FDA will meet separately in January to review safety data.

For some patients, warnings about painkillers have only increased their anxiety. With each new finding, Judi Yazzolino, who has been on Vioxx, Celebrex and naproxen, grows more alarmed. And not because she's worried about heart attack or stroke.

"My fear is, oh no, what if I'm not able to get any of these drugs?" she said. The 56-year-old sales manager, who's on the board of the Washington chapter of the Arthritis Foundation, suffers from both rheumatoid arthritis and osteoarthritis. So does her 80-year-old mother.

"Without medication, the pain is debilitating," Yazzolino said. "My life as I want to live it -- working, being active, skiing -- depends on these drugs."

The Issaquah woman was on Vioxx for about a year when it was pulled from the market. She switched to another drug, Mobic -- which has not been implicated in heart problems but does carry risks of stomach pain and ulcers.

She also gets infusions of Remicade, which she calls her "lifeline" because it blocks painful flare-ups of rheumatoid arthritis. In October, its maker warned doctors that the treatment may put patients at higher risk for lymphoma, a type of cancer.

Meanwhile, Yazzolino's mother went off Celebrex last week and is taking extra-strength Tylenol until she can get in to see her doctor.

"But even Tylenol is bad for your stomach," Yazzolino said. "My guess is there are problems with lots of these drugs; you just have to weigh the risks."

Gardner said other medications besides conventional nonsteroidal anti-inflammatory drugs are available for pain relief or arthritis treatment. Those include acetaminophen, generic salicylates, glucosamine and steroid injections in the joints.

Weight loss and exercise also help. Some studies indicate aerobic exercise is almost as effective as drugs for pain, Gardner said. That may include walking, cycling and water exercise, he said.

Mease urged arthritis patients to educate themselves as much as possible about their disease. Information, he said, is available from the Arthritis Foundation.

By Warren King and Julia Sommerfeld.


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