By ANTHONY CRONIN
Day Staff Writer
Published on 2/1/2005
The nation's largest health maintenance organization said Monday that its pharmacies would no longer dispense the Bextra pharmaceutical made by Pfizer Inc. because of concerns over the arthritis drug's overall safety.
Kaiser Permanente, the Oakland, Calif.-based not-for-profit HMO, said it was concerned about the cardiovascular risks associated with Bextra, which is a COX-2 inhibitor drug that is used to treat acute pain and inflammation, such as that suffered by those with arthritis-related conditions.
Beverly Hayon, a spokeswoman for Kaiser Permanente, said the company's pharmacies would not dispense the drug until the managed-care provider feels more comfortable with the drug's safety record concerning heart attacks and strokes. She said the decision affects Kaiser Permanente's pharmacies and does not affect its HMO coverage. “If Bextra is absolutely necessary for a patient, it won't be denied,” she said.
The whole class of COX-2 drugs came under increasing scrutiny after New Jersey-based Merck & Co. in late September pulled its Vioxx drug off the shelves when it was shown to increase the risk of heart attacks and strokes. Kaiser Permanente was involved in the studies that showed the strong connection between Vioxx and cardiovascular risk.
Since then, the remaining COX-2 drugs on the market, Pfizer's Celebrex and Bextra, also have come under criticism and increased scrutiny for harmful cardiovascular effects. Pfizer has maintained that its drugs have a different molecular composition from Vioxx and both remain on the market. Pfizer also has said it welcomes hearings next month by the federal Food and Drug Administration in Gaithersburg, Md., which will explore the safety and efficacy of the drugs. As a result of the publicity surrounding the COX-2 drugs, the FDA has recommended that doctors now consider alternatives to both Celebrex and Bextra.
On Monday, the Washington, D.C.-based consumer group Public Citizen repeated its call that the FDA pull both Celebrex and Bextra from the market because of the concern over heightened risk of heart attack or stroke. The group also accused Pfizer of attempting to hide a study that suggested that Celebrex may boost the risk of heart attack and stroke. Last week, Public Citizen filed a petition with FDA officials urging the federal regulatory agency to pull Celebrex and Bextra from the public.
A Pfizer spokesman was unavailable to comment.
Kaiser Permanente serves 8.2 million patients in nine states and the District of Columbia, Hayon said. It has no Connecticut operations. She said Kaiser's network of pharmacies would stop filling new prescriptions for Bextra starting today and stop doing refills as of March 1. The health-care provider also plans to notify physicians about other alternative medications and has not stopped its pharmacies from providing Celebrex, Pfizer's other more popular COX-2 inhibitor.
Many patients have said they preferred the COX-2 drugs to more common over-the-counter pain relievers such as acetaminophen products like Tylenol or ibuprofen products like Motrin because the COX-2 drugs don't produce stomach upset or gastrointestinal bleeding that can be produced by the over-the-counter medications. Some physicians and health-care providers have said that the COX-2 drugs in some cases provide only slightly better relief, or the same relief, as the over-the-counter medications.