Army Doctor: Soldiers Need Vioxx, Similar Drugs
FDA Advisory Committees Enter 2nd Day Of 3-Day Hearing
POSTED: 8:31 am EST February 17,
2005
UPDATED: 5:49 pm EST February 17,
2005
WASHINGTON -- While most of the talk lately has been about yanking some popular painkillers off shelves, not everybody feels that's a good idea.
An Army doctor testified Thursday that the pain relievers are "essential to the global war on terror" when it comes to keeping troops on the battlefield. Dr. Christopher Grubb told a joint meeting of Food and Drug advisory committees that the drugs are better than aspirin, which could cause excessive bleeding.Another witness told the panels that Vioxx gave her her life back. But Dimitra Poulos said since the drug was taken off shelves, she has 40 pills and 40 days before her "life will be altered."The health panels are studying the risks of Vioxx and other drugs in a similar class. Vioxx was benched after studies indicated long-term users suffered higher risks of heart problems and stroke.There are similar questions about Celebrex and Bextra. An FDA whistleblower also testified Thursday, saying the whole class of drug may pose a heart hazard. Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation and Research, told the advisory panels that the painkiller Vioxx poses a risk of as many as thousands of additional heart attacks.Merck & Co. pulled Vioxx off the market in September after a study found increased heart and stroke risks among users.Graham also said he thinks there's a heart hazard from using a similar drug, Celebrex, at high doses. Graham said the problem may cover the whole class of drugs, which also includes Bextra.The drugs, designed to help people in chronic pain from conditions such as arthritis, are known as Cox-2 inhibitors. Celebrex and Bextra -- made by Pfizer -- remain on the market, although some studies have also indicated they, too, may carry an added heart risk. The advisory panels are in their second day of a three-day meeting focusing on the safety of Cox-2 inhibitors. At least two other such drugs are awaiting approval.Meanwhile, an official with Merck & Co. told the panels Wednesday that all Cox-2 inhibitors may cause heart problems or strokes. It's a change from the drugmaker's earlier position.Merck research head Dr. Ned Braunstein said that since the company pulled Vioxx from the market last year, studies suggesting similar problems with Celebrex and Bextra have changed his mind.
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Painkillers Under Federal Microscope|
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Survey: Use A Cox-2 Inhibitor?
More Info: FDA Advisory Meeting On Arthritis Drugs An Army doctor testified Thursday that the pain relievers are "essential to the global war on terror" when it comes to keeping troops on the battlefield. Dr. Christopher Grubb told a joint meeting of Food and Drug advisory committees that the drugs are better than aspirin, which could cause excessive bleeding.Another witness told the panels that Vioxx gave her her life back. But Dimitra Poulos said since the drug was taken off shelves, she has 40 pills and 40 days before her "life will be altered."The health panels are studying the risks of Vioxx and other drugs in a similar class. Vioxx was benched after studies indicated long-term users suffered higher risks of heart problems and stroke.There are similar questions about Celebrex and Bextra. An FDA whistleblower also testified Thursday, saying the whole class of drug may pose a heart hazard. Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation and Research, told the advisory panels that the painkiller Vioxx poses a risk of as many as thousands of additional heart attacks.Merck & Co. pulled Vioxx off the market in September after a study found increased heart and stroke risks among users.Graham also said he thinks there's a heart hazard from using a similar drug, Celebrex, at high doses. Graham said the problem may cover the whole class of drugs, which also includes Bextra.The drugs, designed to help people in chronic pain from conditions such as arthritis, are known as Cox-2 inhibitors. Celebrex and Bextra -- made by Pfizer -- remain on the market, although some studies have also indicated they, too, may carry an added heart risk. The advisory panels are in their second day of a three-day meeting focusing on the safety of Cox-2 inhibitors. At least two other such drugs are awaiting approval.Meanwhile, an official with Merck & Co. told the panels Wednesday that all Cox-2 inhibitors may cause heart problems or strokes. It's a change from the drugmaker's earlier position.Merck research head Dr. Ned Braunstein said that since the company pulled Vioxx from the market last year, studies suggesting similar problems with Celebrex and Bextra have changed his mind.
Previous Stories:
- February 16, 2005: Official: Vioxx Regulators Were Not 'Asleep At The Wheel'
- February 14, 2005: Vioxx, Celebrex, Bextra Linked To Cardiovascular Risks
- January 31, 2005: Kaiser To Stop Dispensing Painkiller Bextra
- January 24, 2005: Researchers: Merck Discredited Initial Vioxx Findings
- December 23, 2004: FDA Launches Review Of Celebrex, Similar Drugs
- December 10, 2004: FDA Strengthens Warnings About Bextra
- October 7, 2004: Vioxx May Not Be Only Drug With Heart Risk
- September 30, 2004: Arthritis Patients Scramble For Alternatives Amid Vioxx Recall
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