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 May 12, 2005
Painkillers Should All Stay on Market, Despite Heart Risks: FDA Panel
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By Amanda Gardner, HealthDay Reporter

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

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.

Most of the panel members recommended including black box warnings on the labels of all three of the drugs to flag the heightened heart risk, and there was much discussion on considering similar warnings for all non-steroidal anti-inflammatory (NSAIDs) drugs, to which cox-2s belong.

In addition, various members of the panel suggested adding patient pamphlets and urging additional physician education in addition to limiting dose and/or duration of the cox-2 drugs.

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.

But even those panel members who voted "yes" to letting Vioxx back on the market added that they had "reservations."

Dr. Steven Nissen of the Cleveland Clinic and others urged limiting the drug to a 12.5 milligram dose. Still others urged starting a patient registry or sending "reminders" six months or one year after a patient started taking Vioxx.

"It would have to be a very restricted access program in which consent would be obtained and, if Vioxx were to come back on the market, limited access and attestation," said panel chairman Dr. Alastair Wood.

"I am worried that if you increase blood pressure over a long period of time, it will have very adverse effects on the health of individuals," said Nissen. "If we do bring it back, the 12.5 milligram dose is the only one I would be comfortable with. I hope everyone understands the implications of a decision to put this drug back on the market."

Of particular concern was the issue of children taking Vioxx. As one of the panel members pointed out, Vioxx is the only cox-2 approved for children with juvenile rheumatoid arthritis and the only of the class available in liquid form. Many panel members felt that children in this category should continue to have access.

In a statement issued late Friday after the Vioxx vote, Merck said only, "Merck has appreciated the opportunity to present data at this advisory committee meeting. We look forward to discussions with the FDA."

The panel's decisions 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 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, of Vanderbilt University Medical School, 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."

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

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 others, including FDA whistleblower Dr. David 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 (www.fdaadvisorycommittee.com ).

SOURCES: Feb. 18, 2005, U.S. Food and Drug Administration (FDA) advisory panel hearings

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