Conflicting news creates dilemma over painkillers
Many patients question whether to continue taking COX-2 inhibitors
Hackensack, N.J. ? The confusion that began three months ago when Vioxx was withdrawn from the market intensified during the past weeks with the halting of studies involving two other widely used painkillers — Celebrex and Aleve. Federal regulators said the drugs showed an increased risk of heart problems.
Most recently, the Food and Drug Administration, in an attempt to clarify the recent data, recommended “limited” use of Celebrex and Bextra, another drug that showed increased heart risks. Both are in the same class as Vioxx, which was withdrawn after a clinical trial found it was linked to higher risk of heart attack and stroke.
“I’ve had an onslaught of phone calls from worried patients,” said Dr. David Arbit, a rheumatologist at The Valley Hospital in Ridgewood, N.J., who treats about 120 patients a week. “Patients are confused and they don’t know what to believe anymore.”
Dr. Ralph E. Marcus said several patients — without even consulting him — stopped taking Celebrex and Aleve when they read the news accounts of potential cardiac risk associated with the medications. Marcus, chief of rheumatology at Holy Name Hospital in Teaneck, N.J., said he advised patients to resume treatment.
“I’ve told them based on one study I would not stop taking the medication,” he said.
John Jenkins, director of the FDA’s office of new drugs, said last week that the agency has not made a final determination about possible regulatory action regarding Celebrex and Bextra. The agency called the advisory an “interim measure,” pending further review of the data, and promised to hold a public meeting on the issue in February.
The FDA also advised consumers who use over-the-counter pain medications such as Aleve or ibuprofen, to strictly follow the label instructions, and to contact their doctors if taking the drugs for more than 10 days.
Health-care analyst Steve Findlay acknowledged recent data presents a confusing situation for consumers, but said they should not be alarmed.
“At this point, everyone needs to take a deep breath and wait to see what the regulatory authorities and the FDA and the companies do once they assess this evidence more fully,” Findlay said.
For critics of the FDA, the confusion and controversy reinforces why there’s “a sustained crisis in faith in both the pharmaceutical industry and in the regulatory system,” said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.
Meanwhile, patients and physicians were left to sort out the information.
Dr. Gilbert Kepecs, chief of rheumatology at Hackensack University Medical Center, said he was still prescribing Celebrex and recommending Aleve despite the new data.
“I don’t think that the recent data has changed anything about the medications,” Kepecs said. “This is calling to light something physicians have known for a long time, that these drugs have certain risks. They’ve always had to be used cautiously.”




