<= Back to Health News
F.D.A. IS ADVISED TO LET PAIN PILLS STAY ON MARKET 2005-02-18
By Gardiner Harris

A panel of experts voted unanimously on Friday to advise the Food and Drug Administration that three leading painkillers -- Celebrex, Bextra and Vioxx -- can cause worrisome heart problems. But it also advised against banning the drugs, though by narrow margins in the cases of Bextra and Vioxx.

Most of the advisory panel's members said that the agency should do the following: place warnings on the drugs' labels detailing their heart risks; ban consumer advertising for the drugs; and require each prescription to include a guide outlining the risks.

''I think physicians need to be more thoughtful about how they use these drugs in the future,'' the panel's chairman, Dr. Alastair Wood, said after the meeting. ''It would be a brave man or woman who started a patient with a clear history of heart disease on these drugs.''

Dr. John Jenkins, director of the Office of New Drugs at the F.D.A., agreed, saying the panel had made clear ''that they felt that these agents should maybe not be as widely used.''

Several panel members said that patients in need of pain relief should first try naproxen, sold as Aleve by Bayer, before taking any of the three painkillers known as cox-2 inhibitors -- Celebrex and Bextra, made by Pfizer, or Vioxx, made by Merck.

The panel voted 31 to 1 that Pfizer should be allowed to continue selling Celebrex, which members said was safer than the other two. The vote on Bextra was 17 to 13 with 2 abstentions, and 17 to 15 on Vioxx.

Vioxx has been off the market since September, when Merck withdrew it after a study showed that it doubled the risk of heart attacks and stroke, but the company told the panel that it might reintroduce the drug.

The F.D.A. is not bound to follow the advice of its panels, but it usually does. Dr. Jenkins said that the agency would announce regulatory decisions within weeks. Merck, he said, would not be allowed to reintroduce Vioxx without coming to agreement with the agency.

Though it is unlikely that the three painkillers will again approach their previous combined sales of $6 billion a year, Pfizer and Merck shares rose sharply, with investors apparently relieved that the panel did not seek to ban the drugs. [Page C1.]

Letting the drugs remain on the market, after a thorough review of the clinical data, could also help the companies build their defenses against lawsuits filed by patients or their survivors. Merck is already a defendant in hundreds of such suits, with some cases expected to go to trial this spring.

The panel was far more comfortable with the safety of Celebrex, particularly at low doses, than with that of Vioxx or Bextra. Still, it rejected Pfizer's insistence that there was little evidence that either Celebrex or Bextra caused heart problems.

Dr. John LaMattina, Pfizer's president of global research and development, said that all pain relievers, with the possible exception of naproxen, seemed to increase the risk of heart attacks. He said doctors should have a ''good handle'' on the risks of pain medications after the advisory meeting.

Dr. LaMattina also pledged that Pfizer would not advertise Celebrex or Bextra in the coming weeks.

''Then after that,'' he said, ''we will discuss with F.D.A. what we should and shouldn't do.''

Most panelists were adamant that the drugs not be advertised unless the advertisements were written by the F.D.A. or an independent group.

Dr. Jenkins of the F.D.A. said it did not have the power to ban advertising. But Dr. Wood said that it was unlikely a company would defy the committee's wishes. ''It would be a brave company that would start an advertising campaign for these drugs,'' he said.

Dr. Jenkins said that ''we heard the message that the committee thought Vioxx had a cardiovascular risk that was perhaps larger or better documented than the others.'' If Merck officials want to reintroduce Vioxx, he went on, ''we'll welcome them to come talk to us about the various paths forward.''

The panel's divided votes on Bextra and Vioxx make interpreting its advice on those drugs more difficult, Dr. Jenkins said.


 
 
 
Patent Pending:   60/481641
 
Copyright © 2024 NetDr.com. All rights reserved.
Email Us

About Us Privacy Policy Doctor Login