FDA Panel: Painkillers OK, But With Restrictions

Friday , February 18, 2005

By Todd Zwillich


Vioxx (search) should be allowed to return to the market, an expert FDA panel recommends. And Bextra and Celebrex (search) should remain on the U.S. market despite their link to heart attacks and strokes.

But most experts said that the FDA should require these drugs to carry a strict “black box” warning alerting patients and doctors to the increased risk of heart attacks and strokes. Many also recommended labeling that limits use of the drug to the lowest effective dose and a ban on direct-to-consumer advertisements promoting the drug.

The panel recommended by a 17-15 vote to allow Vioxx to return to the U.S. market from a voluntary Merck recall. Those who supported the drug’s return did so largely under the condition that the FDA place strict warnings on the drug’s label while ordering limits on the dosage amounts for patients. Some said the drug should only be allowed to be used in its liquid form by children who suffer from juvenile rheumatoid arthritis.

“If we do bring the drug back I think that the 12.5 mg dose is the only dose I would be comfortable with,” said Steven Nissen, MD, a panel member and medical director of the Cleveland Clinic.

Vioxx maker Merck says they will consider bringing Vioxx back to the market – depending on the FDA’s official position on this.

Several experts also suggested that patients be forced to sign consent forms before using Vioxx.

The FDA is expected to make an official decision regarding these pain relievers in the next few weeks. The agency typically follows the advice of its expert panels.

Earlier, experts voted 17 to 13, with 2 abstensions, against banning Bextra (search). The drug was shown to raise heart risk in patients who’ve recently had heart bypass surgery, but experts complained that they have little solid data on whether or not it is safe for use in the rest of the population.

Those who supported allowing Bextra to continue on the market said that it should carry similar black box warnings and advertising limits to those recommended for Celebrex and Vioxx.

A Celebrex study at the National Institutes of Health was halted in December after researchers saw that patients taking 400 mg per day of the drug had a 2.5-fold increased risk of heart attack and stroke. Patients taking 800 mg per day had a 3.4-fold risk over those taking a placebo.

Another NIH study in which patients took 200 mg per day showed no apparent heart risk.

Some committee members said they were reluctant to recommend removing an effective pain reliever from the market that many patients have come to rely upon.

“Taking them out of the hands of physicians as though they were a smoking gun is probably too extreme,” said Robert H. Dworkin, PhD, a professor and researcher at the University of Rochester School of Medicine and Dentistry in New York.

Earlier the panel voted 33-1 to recommend that Celebrex stay on the market. Arthur A. Levin, director of the Center for Medical Consumers, was the only panelist opposed to Celebrex. He tells WebMD that regulators will not be able to prevent patients from taking potentially dangerous higher doses.

“We’re talking about a risk here that if the estimates are right, is enormous. I mean, we’re talking about thousands of lives” at risk from heart attacks, says Levin.

By Todd Zwillich, reviewed by Michael W. Smith, MD

SOURCES: Robert H. Dworkin, PhD, professor of anesthesiology, neurology, oncology, and psychiatry, University of Rochester School of Medicine and Dentistry in New York, FDA panel member. Arthur A. Levin, director, Center for Medical Consumers, FDA panel member.