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Painkillers Likely To Be Removed From Market

Feb 16, 2005 | Doctors who authored a sweeping series of studies summarizing the dangers of the painkilling drugs called COX-2 inhibitors say all of the medications are at risk of being removed from the market.

With Wednesday's opening of a three-day Food and Drug Administration meeting that will weigh the fate of the drug family, the New England Journal of Medicine released a string of reports a month early, confirming what preliminary studies have already seen cardiovascular dangers linked to Vioxx, Celebrex and Bextra. Although Vioxx was voluntarily pulled from the market in September by Merck & Co., its maker, the other Pfizer products remain.

Researchers believe the drugs cause cardiovascular damage by adversely affecting the chemistry in the endothelium the lining of blood vessels. By contrast, aspirin confers protection, scientists say. The COX-2 drugs, on the market only since 1999, had been dubbed "superaspirin" and were designed to be safer than the old medicine cabinet standby.

In the research reported Wednesday, the cardiovascular dangers of Vioxx and Celebrex were confirmed in two studies whose aim was preventing new colorectal polyps in patients previously treated for the precancerous growths. A third study of heart surgery patients on Bextra showed an increased rate of death and other adverse effects as a result of the drug.

Dr. Jeffrey Drazen, editor of the New England Journal of Medicine, wrote in an accompanying critique that it is "reasonable to ask whether the use of the drugs can now be justified."

In addition to the heart attacks and strokes reported last year among patients on Vioxx in the polyp study, Dr. Robert Bresalier, lead researcher, said further investigation uncovered hypertension, pulmonary edema and congestive heart failure. Those problems did not occur in as many patients nor with the frequency of the heart attacks and strokes that ended the study last year.

Bresalier said Vioxx nearly doubled patients' cardiovascular risks.

"We just have to sit back now and when the smoke clears try to assess the risk versus benefit with these agents for a whole spectrum of diseases," Bresalier said of cancer, heart disease, arthritis and Alzheimer's. COX-2 inhibitors have been approved only for chronic pain and were being tested in cancer prevention and treatment. Another study, now halted, was investigating the merits of COX-2 therapy for Alzheimer's.

Dr. Scott Solomon of Brigham and Women's Hospital in Boston and lead investigator of the second polyp-prevention study in which patients received Celebrex or a placebo, said the jury's still out on whether the medication prevented polyps. Those results, he said, won't be known for at least three months. "Right now we just know the risks. All drugs carry risks and we need to weigh those against any potential benefits."

The third study, at the Texas Heart Institute and led by Dr. Nancy Nussmeier, found that in heart surgery patients, 7.4 percent had heart attacks, experienced kidney damage, developed ulcers or had problems with wound healing.

Doctors Bruce Psaty and Curt Furberg, who wrote a second editorial about the studies, said that in the face of the news "physicians are dismayed, pharmaceutical companies are embarrassed and financially threatened, and patients are injured."

In a phone interview Tuesday, Psaty, a professor of medicine at the University of Washington in Seattle, said COX-2 drugs have many problems.

"As a patient I don't take them; as a physician, I don't prescribe them. I think we'll have to see what the totality of the evidence looks like at the FDA hearing whether they should remain on the market."

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