Maybe Less Use of the Prescription Pen

By ANAHAD O'CONNOR

Published: April 8, 2005

Concerns about prescribing pain relievers deepened yesterday, doctors said, after the announcements that Pfizer would withdraw its embattled painkiller Bextra from the market and that tough warning labels would be added to other leading pain medications.

The drugs, which have come under increasing scrutiny, will most likely be prescribed for shorter periods, while patients in higher risk groups will be encouraged to try alternatives, like low dose opiates and pain patches, according to doctors interviewed yesterday.

"We used to just put people on these drugs for life and not think about it, but we can no longer commit them to lifelong therapy with impunity," said Dr. Thalia Segal, a pain specialist at New York University. "We have to use these medications judiciously and follow people more closely. We have to rely on a much more individualized approach."

The Food and Administration said yesterday that it was instructing drug makers to add warning labels surrounded by bold black boxes to nonsteroidal anti-inflammatory drugs because they increase the risk of cardiovascular disease. The agency took more severe action against Bextra, one of two pain relievers on the market that selectively block cox-2 enzymes because studies showed that the drug also heightened the risk of a potentially deadly skin disease. Cox-2 enzymes can promote inflammation.

Of all the traditional nonsteroidal anti-inflammatory drugs, only aspirin, which has special anticlotting effects that benefit the heart, has been spared the black-box warning.

With the announcement about Bextra, several physicians interviewed said they would now weigh the risks and benefits of the drugs case by case and would rule out Celebrex, the remaining cox-2 inhibitor on the market, for their elderly patients and others at the greatest risk of cardiovascular problems.

They also said they would continue to prescribe, with caution, the more traditional anti-inflammatories like ibuprofen, combining them with medications that protect against gastrointestinal irritation.

"The silver lining in all of this is that for most patients there are alternatives to the cox-2 inhibitors," said Dr. Raymond Gaeta, the director of the pain management center at Stanford. "Over-the-counter Advil will probably be just fine for most people with the usual aches and pains. But doctors will really need to just sit down with their patients and discuss some of the alternatives."

Among the alternatives, he says, are opiates, which are less likely to lead to addiction when taken at low doses. They include drugs like OxyContin and hydrocodone.

Dr. Segal, the pain specialist at N.Y.U., said she had also begun recommending that some of her patients take older anti-inflammatories in compounded, or cream, form that allows them to be applied locally.

"When you compound these drugs, that means the heart won't see it, and the stomach won't see it," she said. "So for people who I'm not going to give a cox-2 and also have a history of ulcers, the way around it is to take the anti-inflammatory and make it into a cream."

But some doctors said they would not alter or reduce their use of the older pain relievers because their risks were minimal and had been known for some time. Dr. Elinor A. Mody, a rheumatologist at Brigham and Women's hospital in Boston, said drugs like ibuprofen and naproxen had been swept up in the controversy over the cox-2's.

"I think frankly that this is just backlash and a little bit of the pendulum swinging in the other direction," she said. "If this information about their safety had come out six months or a year ago, we would have noted it in the journals and said we needed more study, but the F.D.A. wouldn't have necessarily acted."

Unlike other older nonsteroidals, aspirin does not cause blood platelets to stick together, lowering the likelihood of plaque formation and heart attacks. Celebrex, on the other hand, is considered to be less harmful to the heart than Bextra because it has less effect on cox-2 enzymes.