Bextra Taken Off Market; Celebrex Gets Warning
Other Anti-Inflammatory Drugs Also to Carry Warnings of Heart, Stomach Risks
Standing Up for Patient Safety
The FDA's decision on Bextra went against the February recommendations of the FDA's advisors, who voted 17 to 13, with two abstentions, to allow the drug to stay on the market. Galson said that the decision reflected a conservative approach to the panel's largely split recommendations on Bextra and other drugs.
Curt D. Furberg, MD, a member of the panel who also led the January Bextra study, praised the agency for "standing up for patient safety" with Thursday's decision.
"If you were on a plane and 17 pilots said it was safe to fly, and 13 said it was not safe, and then two abstained, would you fly?" Furberg, professor of pubic health sciences at the Wake Forest University School of Medicine, says in an interview.
He added that the agency's order for new warnings for all NSAID drugs will also likely influence drugmakers to conduct new safety studies. "You now have an incentive to show you're different from the others," Furberg says.
But Elizabeth Tindall, MD, president of the American College of Rheumatology, tells WebMD she was "shocked" by the FDA's decision to pull Bextra and extend heart risk warnings to all NSAIDs. Many patients will now be afraid to take the drugs despite severe pain, she warns.
"I don't know how else to deal with it except on a patient-by-patient basis," taking into account individuals' risk factors, says Tindall, who is a professor of medicine at the Oregon Health and Sciences University in Portland.
"It's a matter of going to every patient and talking with them about what is the most appropriate course. I'm reeling. I'm really very, very surprised," she says.
The news about Bextra is "surprising and a little bit aggravating," says Stephen Lindsey, MD, chairman of the rheumatology department at the Ochsner Clinic Foundation in Baton Rouge, La.
Lindsey says he wishes more leeway had been given to use Bextra and Vioxx in patients without heart and stroke risks. "A lot of our patients are young women with rheumatism who are 25, 30 years old, who benefit a lot from this kind of medicine," says Lindsey. "There are a lot of 'weekend warriors' who use [the drugs] for a couple of weeks."
He says many people might be able to take the drugs with no problems if they took them intermittently, which hasn't been studied. "The studies were long-term studies with older folks," he says.
Lindsey says his patients taking Bextra and similar drugs have already been screened for any heart or stroke risk. That started six months ago, when the controversy began, so he doesn't plan to take anyone off Celebrex, which is still on the market.
"My job is to help people function better, have less pain, [be able to do] daily activities and have fun without hurting them. You have to think about benefits and risks," says Lindsey.