For Pain Management, Doctors Prescribe Caution

By MARY DUENWALD

Published: February 20, 2005

After a panel of medical experts gave a very cautious nod to the continued use of the painkillers Celebrex, Vioxx and Bextra on Friday, pain management experts said they expected to see the same caution transform the way the painkillers are prescribed from now on.

The drugs, which had been hugely popular for people with both short-term and chronic pain, will be prescribed much less readily, for a smaller group of patients, at lower doses and for shorter periods, the experts said.

"I am still very concerned about the cardiac risks of these medications," said Dr. David Campen, director of pharmacy services at Kaiser Permanente in Oakland, Calif., who led an effort to shift Kaiser patients off Celebrex and Vioxx and onto other painkillers. "If you can get away with a safer medication, you ought to."

But doctors expressed relief that they are likely to still have the drugs at their disposal.

"All of us have been reacting to the news as it comes forward, as to whether some of our tools will be taken off the market," said Dr. Raymond Gaeta, an anesthesiologist who directs Stanford's pain management clinic. "This is good news for patients over all. Clearly there are side effects with every medication, but it's really important to weigh the potential side effects versus the benefits for an individual patient."

On Friday the panel warned that all three drugs increased the risk of heart attack and strokes, although Celebrex is less hazardous than the other two, and recommended that the Food and Drug Administration place new warnings to that effect on their labels. But the experts also said the benefits to some patients outweighed the risks and concluded that the drugs should remain on the market. The agency usually follows the advice of its advisory panels.

While acknowledging the risks of the drugs, doctors pointed out that no drug was perfect for every patient. "As a physician, I like to have a choice of treatments, because people are different and some respond well to them," said Dr. James F. Fries, an arthritis specialist at Stanford University.

Dr. Sudhir Diwan, director of the division of pain medicine at New York-Presbyterian Hospital, said, "We all have found that these drugs can be very, very good in pain control and easy on the stomach," adding, "But it is true that we must do a better job of informing the public that these medications do have side effects."

Before prescribing any of the three drugs, doctors should carefully evaluate their patients' risk of heart problems, said Dr. Garret A. FitzGerald, a cardiologist at the University of Pennsylvania medical school, in Philadelphia, who was among those who spoke before the F.D.A. panel to warn of the drugs' risks. "Obviously one of the things to check is blood pressure," Dr. FitzGerald said. "And it's certainly wise to look at an echocardiogram to see if there is any impairment in cardiac performance." He said such drugs could help some patients with chronic pain who are prone to stomach irritation.

Anyone who has had a stroke or who has existing heart disease should be kept off the drugs, said Dr. Gaeta of Stanford, as should someone with obvious heart disease risk factors, like a diabetic smoker.

Unfortunately, many patients who are candidates for Celebrex, Vioxx and Bextra, because they are prone to stomach bleeding, are the same ones who are at risk for heart attack, said Dr. Campen of Kaiser Permanente. These patients tend to be older or have other health problems.

Doctors should also stick to low doses of the medications, said Dr. Fries, the Stanford arthritis specialist, noting that in the studies that have shown heart risks, patients took relatively large amounts.

Patients should take 10 milligrams of Bextra a day, rather than 20, he said, and 200 milligrams of Celebrex, rather than 400. And if Vioxx comes back on the market, it should be prescribed in 25-milligram doses rather than 50, Dr. Fries said.