January 31, 2005 12:03 PM
Big Health Plan Suspends Use of Painkiller
Excerpt: Kaiser Permanente, one of the nation's largest managed care organizations, has ordered its pharmacies to stop dispensing Bextra, an arthritis and pain drug made by Pfizer that some tests have indicated may increase the risk of heart attacks and strokes.
Kaiser Permanente, one of the nation's largest managed care organizations, has ordered its pharmacies to stop dispensing Bextra, an arthritis and pain drug made by Pfizer that some tests have indicated may increase the risk of heart attacks and strokes.
Bextra is in the same class of drugs as another Pfizer painkiller, Celebrex, which has also been found to pose cardiac risks at high doses, and as Vioxx, the drug that Merck pulled from the market last fall after its own tests disclosed cardiac risks.
Merck announced yesterday that the Securities and Exchange Commission had opened a formal investigation of Merck's handling of issues related to Vioxx.
The suspension of Bextra is the first case of Kaiser's doctors deciding to ban use of a drug that has been approved by the Food and Drug Administration, said Dr. Sharon Levine, associate executive director of the company's Northern California unit.
Dr. Levine said the decision was unlikely to affect many of Kaiser's nine million patients around the country, since Kaiser physicians had already avoided using the drug. But "for safety and quality reasons, we don't want to be involved in dispensing this drug," she said.
A ban by Kaiser, whose practices are in many ways a model for other health care providers, could further damp sales of Bextra, which had sales last year of $1.29 billion. Those sales have already slumped since Pfizer acknowledged last fall that studies had shown that the drug increased the risks of heart attack and stroke among patients who have had coronary artery bypass surgery. Many experts have speculated that its risks could be as high as Vioxx's.
Kaiser doctors will continue prescribing Celebrex, Dr. David Campen, Kaiser's medical director of pharmacy services, said yesterday. At low doses, Celebrex does not appear to have the same risks as Bextra or Vioxx, Dr. Campen said.
"But clearly at the higher dose levels, there does seem to be a problem" with Celebrex, he said.
A Pfizer spokeswoman said the Bextra tests in question had involved patients after heart surgery, who were not the target population for the drug, which was federally approved to treat arthritis inflammation and pain. "All the available data suggests there is no increased risk of heart attacks among arthritis patients who take Bextra," she said.
Kaiser said that its Bextra ban would take effect on Feb. 1 for new prescriptions and March 1 for refill prescriptions. The lag is intended to give the group enough time to inform the doctors and dentists who see Kaiser patients, Dr. Levine said.
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