Despite Risks, Pain Relievers Given OK
FDA Panel Says Vioxx Can Come Back, Celebrex, Bextra Should Stay
Feb. 18, 2005 - An FDA advisory panel says the arthritis drug Vioxx can
return to the market and sister drugs Celebrex and Bextra should stay.
But experts say these drugs -- members of a group called Cox-2 inhibitors --
should carry strict warnings that they can raise the risk of heart attacks and
The panel also recommended that labels for many of the more than 20 older
anti-inflammatory drugs be updated to warn consumers and doctors that they may
carry a heart risk. Three of these, ibuprofen, naproxen, and ketoprofen, are
available over the counter.
Experts at the hearings expressed a degree of frustration that companies
have not performed enough studies clearly addressing the safety of Cox-2
inhibitors and older pain relievers. Several urged regulators to require more
safety studies as a condition for allowing the drugs to stay on the market.
"If these products are going to be on the market it should be essential
that we get additional evidence," said panel member Thomas Fleming,
Victory for Vioxx?
The panel also recommended, by a single vote, to leave the door open for
Merck & Co. to return Vioxx to the market following a self-imposed recall.
Merck said that it would consider returning the drug to the market if the FDA
allowed it, but today's 17-15 decision made it unclear how the company would
proceed. The FDA does not have to follow its committees' recommendations,
though it usually does.
Fleming was among the majority of experts who called for the FDA to limit
any future Vioxx use to its lowest 12.5 mg dose. Evidence has shown higher
doses raise blood pressure and the risk of heart attacks and stroke.
It remains unclear whether Merck will attempt to remarket Vioxx with a
low-dose restriction or whether the FDA would allow them to do so.
Merck released a brief statement saying that the company "looks
forward" to discussions with the FDA.
Officials vowed at the beginning of this week's hearing to act within a few
weeks of today's decisions.
Experts strongly resisted banning Celebrex, citing limited evidence that it
is safe at lower doses. At the same time, most urged regulators to bar the use
of higher doses that were shown in one major study to
by up to 3.5 times.
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.