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Painkillers Should All Stay on Market, Despite Heart Risks: FDA Panel

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By Gardner HealthDay Reporter

More on this in Health & Fitness

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Today's Health News

FRIDAY, Feb. 18 (HealthDay News) -- The popular prescription painkil lers

Celebrex, Vioxx and Bextra significantly raise cardiovascular risks, but they

should stay on the market, a U.S. Food and Drug Administration panel determined

Friday.

In three unanimous votes in succession, the advisory group found that all three

drugs in the class of painkillers known as cox-2 inhibitors carry increased

heart risk.

But despite split votes on the question of keeping the drugs on the market, the

panel appeared to determine that their benefits outweighed their risks.

The advisory group, ending three days of hearings, approved recommending

continued use of Pfizer's Celebrex by a vote of 31-1. A majority were also in

favor of requiring a black-box warning on the label to flag the heightened heart

risk.

The panel's vote to recommend continued use of Pfizer's painkiller Bextra passed

17-13, with two abstentions.

And the support for keeping Merck's Vioxx passed 17-15.

The Vioxx vote appeared to ensure the return of the hugely popular drug, which

Merck removed from pharmacy shelves last fall after its own clinical trials

showed the increased heart risks. On Thursday, Merck announced at the hearings

that it would consider resuming sales of Vioxx if the advisers found the

benefits outweighed the risks.

The panel's decisions, which have yet to include all the warnings under

discussion, will be forwarded to the FDA for final action. The agency had

promised, as the hearings got under way Wednesday, that it would act fairly

promptly, and while it is not required to follow its advisers' recommendations,

it usually does.

The panel's rapid actions followed a summation by committee chairman Dr.

Alastair Wood, who made it clear Friday morning at the end of public testimony

that there were significant safety issues posed by all the cox-2s.

" This is a much bigger safety problem than with the other drugs the FDA has

withdrawn, " Wood told the assembled crowd. " And the only reason we have agonized

so much is that this is a relatively common problem, and therefore much harder

for us to be sure the signal is clear. "

While acknowledging that patient testimony heard on Thursday was " both moving

and important, " Wood, of Vanderbilt University Medical School, added, " No one

has been able to demonstrate specifically a better response amongst any of these

drugs in individual patients in any randomized way. "

All of this, he added, brings the panel of 32 scientists and doctors to the $64

million question: " What should we do? "

" The committee needs to act in a way that limits the hazard to patients, " he

said. " The public has a right to expect us to do that. When we leave here

tonight, we need to have made really clear recommendations to the FDA, which

will help them move forward. "

Wood's remarks came right after representatives of drug companies made

last-ditch presentations in defense of their drugs, whose original design was to

reduce the risk of gastrointestinal danger.

And they followed Merck's surprise announcement that it may put Vioxx back on

the market, depending on the hearing outcome.

" If the advisory committee and the FDA conclude that the benefits of this class

outweigh the risks in some patient populations, then we would have to consider

the implications of these new data given the unique benefits Vioxx offers, " the

Merck & Co statement said, according to a CNN report.

The popularity of painkillers like Vioxx was very much in evidence during

testimony from the public at the hearing Thursday. At least a dozen people took

to the podium with personal stories of pain relief and asked the FDA advisers to

keep the cox-2s on the market.

The panel's decisions came despite damning testimony from many, including FDA

whistleblower Dr. Graham.

" There's a one-in-50 chance that a male aged 65 to 74 will have a heart attack

this year. Increase that fivefold with high doses [of Vioxx], " Graham told the

FDA advisers Thursday.

" That's what happened with VIGOR [a 2000 manufacturer's trial comparing

gastrointestinal effects of Vioxx and another painkiller, naproxen]. If you have

millions of people taking high doses, you're going to get numbers that balloon

out, " he said.

Graham said he believed the negative cardiovascular effects of Vioxx were

dose-dependent, meaning higher doses had a bigger effect, and that the risk

kicked in immediately, within the first 30 days. Both issues have been subjects

of debate.

Celebrex had no effect on the heart at doses of 200 milligrams or less, Graham

added, but did have an increased risk at higher doses.

And, he added, the little information that exists on Bextra indicates no risk at

small doses.

The FDA advisory action comes a day after the European Medicines Agency,

Europe's most powerful drug regulator, mandated its own stronger warnings on

cardiovascular risks for all cox-2s, the Associated Press reported.

More information

More about the hearings is available at the FDA .

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