Celebrex, Bextra Face FDA Scrutiny This Week
FDA Practices May Also Face Debate, Official Says
WebMD News Archive
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
"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
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 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
"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.