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    Celebrex, Bextra Face FDA Scrutiny This Week

    FDA Practices May Also Face Debate, Official Says


    The decision of officials to halt the study remains controversial amid criticism that evidence of Aleve's adverse effects was weak.

    In response to the Aleve results, John H. Klippel, MD, president of the Arthritis Foundation, told WebMD in December, "We are talking about a drug that has been around for 30 years and used by millions of people, and we are not aware that this issue has been raised elsewhere. So we don't believe this should have any immediate impact on the clinical use of this drug."

    Also in December, the FDA issued strengthened warnings alerting doctors to a study showing that Bextra, also made by Pfizer, increases the risk of heart attack and stroke in patients who have had heart bypass surgery. Pfizer is a WebMD sponsor.

    "If they were doing the right thing, they would take both of them off the market," says Sidney Wolfe, MD, director of Public Citizen's Health Research Group. The group has petitioned the FDA to ban both Celebrex and Bextra.

    Eric Topol, MD, a cardiologist and leading Cox-2 researcher, warns that the highly charged atmosphere surrounding Vioxx and other drugs could lead to "hyper-responsiveness" by the FDA concerning related medications, especially Bextra. In December, the FDA issued a warning to not use Bextra in patients having heart bypass surgery.

    But at a minimum, the FDA should consider similarly strict warnings alerting doctors and patients to the possible heart risks of Celebrex, Topol tells WebMD.

    "Celebrex can't go on as it has been," says Topol, a provost at the Cleveland Clinic Lerner School of Medicine.

    But others stress that despite increased safety concerns, Cox-2 drugs still have an important role in treating arthritis patients. Many doctors still value Celebrex and Bextra because of their ability to avoid stomach and intestinal bleeding sometimes seen with older anti-inflammatory drugs.

    Cox-2 drugs also remain important for elderly arthritis patients on blood-thinning medications, such as Coumadin, who cannot take the older drugs because they can interfere with blood clotting, says William Shiel, MD, a practicing rheumatologist from Mission Viejo, Calif.

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