Despite Risks, Pain Relievers Given OK
FDA Panel Says Vioxx Can Come Back, Celebrex, Bextra Should Stay
Victory for Vioxx? continued...
The panel more narrowly gave its approval to allow the continued sale of Bextra, strongly urging in a 17-to-13 vote, with two abstentions, not to ban the drug provided its manufacturer, Pfizer, warns patients of its risks and quickly perform studies establishing its safety.
"Taking them out of the hands of physicians as though they were a smoking gun is probably too extreme," said Robert H. Dworkin, PhD, a professor and researcher at the University of Rochester School of Medicine and Dentistry in New York.
But the FDA should also require strict "black box" warnings on all three Cox-2 drugs to alert patients and doctors to their risks, panel members said. A black box warning is the most serious warning placed on the labeling of a prescription medication.
Most panel members also urged the agency to use its influence with manufacturers to secure a moratorium on direct-to-consumer promotions and advertising.
FDA officials said they don't have the authority to ban the ads outright.
"I think that the committee wanted to send a very clear message that direct-to-consumer advertising for these drugs was inappropriate," panel chairman Alistair J.J. Wood, MD, told reporters following the hearing.
Warnings for Older Pain Relievers
The committee unanimously recommended that more than 20 older anti-inflammatory drugs also carry precautions of potential heart risks on their labels. It did not specify which drugs should carry the warnings or how strong they should be.
Some of the older NSAIDs, including diclofenac and Mobic, are similar chemically to Cox-2 drugs and may have to carry warnings because of limited evidence that they can influence heart attacks. Many others have never been studied to determine their potential effects on the heart.
A study among California Medicaid patients showed an increased risk of heart attack with several older anti-inflammatory drugs, including ibuprofen. That drug appeared to raise the users' risk of heart attack by 11%.
FDA scientist David Graham, MD, referred to this as "small but significant" since tens of millions of Americans use the drug regularly.
Other anti-inflammatory drugs, including indomethacin and Mobic, also appeared to raise heart attack risk by 40% to 70%, according to the study.