Bextra banned by Kaiser Permanente
Bextra, a Cox-2 drug, that was prescribed as an alternative to Vioxx and Celebrex, has been banned by Kaiser Permanente, a HMO based in Oakland, California. It may be recalled that a warning about Bextra is already in place by the FDA (and other drug agencies all over the world) while it reviews the complete family of drugs. The FDA issued the warning in December last year after research disclosed several adverse side effects of Bextra. (Related article: Vioxx recall focuses limelight on all Cox-2 inhibitor drugs)
This is a remarkable development since Kaiser Permanente is the largest HMO in the United States. The program has approximately 8 million members. Analysts expect that other healthcare providers will follow suit soon, may be even before the FDA and European Medicines Agency (EMEA) announce their decisions whether to ask Pfizer to recall Bextra. Pfizer was asked by the FDA to stop all direct-to-consumer advertising related to Bextra and later FDA issued a warning letter to Pfizer detailing how Pfizer has engaged in misleading advertising.
Kaiser said that its Bextra ban would take effect right away for new prescriptions and March 1 for refill prescriptions. Kaiser said its moratorium on Bextra will continue for six months, or until the FDA or the drug's manufacturer, Pfizer Inc., can prove the drug is safe, according to a Kaiser press release. (Related article: Bextra safety doubted in two studies)
Since the recall of Vioxx in September of 2004 by Merck, other drugs like Celebrex, Bextra, Prexige, Arcoxia, etc. have come under greater scrutiny. Several studies have shown that these drugs provide little or no benefit when compared to inexpensive, over-the-counter drugs like Ibuprofen and Paracetamol. Most of the benefits that Pfizer and Merck claimed about their drugs were never really proved. (Related article: Vioxx should have never been approved)
Most doctors and patient rights groups have been demanding that Bextra should be recalled at least till its safety profile is better understood. (Related article: Bextra safety update from Pfizer) Merck, the manufacturer of Vioxx, is expected to face tens of thousands of plaintiffs in class action lawsuits all over the world. Merck is also being investigated by the Department of Justice, the Securities and Exchange Commission (SEC), and Congress for hiding information about side effects of Vioxx and for misleading patients, doctors, and investors. (Related article: Merck being formally investigated by SEC for Vioxx recall)
Pfizer, which has so far stood by the safety of both Celebrax and Bextra, and has repeatedly refused to recall either or both the drugs, is also facing a series of class action lawsuits from patients and shareholders. (Related article: Bextra class action lawsuits against Pfizer grow)
In the aftermath of the Vioxx recall, Pfizer benefited a lot as arthritis patients switched to Celebrex or Bextra. However, after reports about Bextra were published in December last year, prescriptions for Bextra have dropped rapidly. (Related article: Pfizer sales hurt by drop in Bextra prescriptions)
A ban by Kaiser Permanente on Bextra, apart from pushing other HMOs to do the same, will also put pressure on the FDA to review the risks more carefully. Legal experts say that if HMOs do not take action right now and if at some point Celebrex and Bextra are found to be responsible for injuries (Related article: As many as 140,000 Americans alone are reportedly injured by Vioxx), they will also be liable like Pfizer for knowingly causing death and injuries.
Recommended article: FDA recommends limited Bextra prescriptions after Vioxx scare
