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Celebrex, Bextra Face FDA Scrutiny This Week

FDA Practices May Also Face Debate, Official Says

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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.

"I don't want to lose them. I qualify that by saying I want to have this whole [safety] issue clarified," says Shiel, who is also editor of MedicineNet.com, which is owned by WebMD.

The hearings are also likely to focus attention on whether Cox-2 drugs are inappropriately prescribed to many of the millions of patients who take them, Shiel says. A national study released on Jan. 24 concluded that patients who could have taken older and less expensive arthritis drugs still accounted for 64% of the growth in Cox-2 prescriptions between 1999 and 2002.

Cox-2 safety concerns have also brought scrutiny on the FDA itself. Shortly after Merck & Company pulled Vioxx from the market in September 2004, FDA safety reviewer David Graham, MD, appeared on Capitol Hill complaining to lawmakers that his repeated warnings about the drug's safety were stifled by higher-ups in the agency.

Graham cited five other drugs, including Bextra, as suffering from significant safety concerns and warned that the FDA was unable to protect Americans' safety.

The Institute of Medicine has launched an inquiry into how well the agency monitors the safety of drugs already on the market. Several lawmakers have backed calls to reform the agency by establishing an independent drug safety office.

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