Kaiser Permanente Bans Use of Bextra Over Safety Concerns
California-based Kaiser Permanente, the nation's largest not-for-profit HMO, last week ordered its pharmacies to stop dispensing Pfizer's COX-2 inhibitor Bextra because of evidence that it might increase the risk of heart attack, the Los Angeles Times reports. Kaiser spokesperson Beverly Hayon said this is the first time the HMO has decided to ban the use of a prescription drug approved by FDA.
Kaiser's new policy on Bextra cites "significant concerns about the safety of the drug." According to the policy, "Kaiser's pharmacies in California will cease filling prescriptions for Bextra, and prescribers will be contacted with suggested alternatives" (Vrana, Los Angeles Times, 1/30). Sharon Levine, Kaiser's associate executive director of the company's Northern California unit, said the company decided to stopping filling Bextra prescriptions because the medication showed no unique benefits that outweigh possible risks. She noted that older medicines like ibuprofen and diclofenac were just as effective in curing pain in clinical trials and that there is no evidence that Bextra is safer for the stomach. She added, "[F]or safety and quality reasons, we don't want to be involved in dispensing this drug."
David Campen, Kaiser's medical director of pharmacy services, said patients will still be able to receive and fill prescriptions for low doses of Celebrex, another COX-2 inhibitor manufactured by Pfizer. Campen said studies of Celebrex in low doses did not show the same risks as Bextra or Merck's COX-2 inhibitor Vioxx, which was voluntarily withdrawn from the market in September 2004. However, "clearly at the higher dose levels, there does seem to be a problem" with Celebrex, he said. Levine said the ban is not likely to affect the insurer's nine million patients because its doctors already have been avoiding prescribing the medication (Harris, New York Times, 1/29).
New prescriptions for Bextra will not be filled after Tuesday, and patients will not be able to get refills as of March 1. Kaiser will refrain from dispensing Bextra for at least six months or until FDA or Pfizer can prove its safety, the San Francisco Chronicle reports (Fulbright, San Francisco Chronicle, 1/30).
According to the Los Angeles Times, "A ban by Kaiser ... could prompt other doctors and HMOs to avoid the drug." Pfizer officials were not available for comment (Los Angeles Times, 1/30).