Companies Debate Arthritis Drug Safety At FDA; Whistleblower To Air New Pain Drug Analysis
10/19/2005 5:12:45 PM
The maker of Celebrex and Bextra says the two prescription painkillers are safe, even as an official of another company that makes a similar drug says he believes all drugs in the same class may pose heart or stroke problems. Merck & Co., pulled Vioxx from the market after a long-term trial indicated that users of the popular pill could have a variety of problems from stroke to irregular heartbeat to heart attack.
Officials of Pfizer Inc. told a joint meeting of two Food and Drug Administration (news - web sites) advisory committees on Wednesday that they believe the company's Celebrex and Bextra remain safe and effective treatments for chronic pain.
When Merck withdrew Vioxx on Sept. 30 the company acted because it feared some problem with the drug itself was leading to the strokes and heart trouble.
But Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, told the panels that since then studies suggesting similar problems with Celebrex and Bextra have changed his mind.
"The data strongly suggest it is a class effect" for all drugs of that type, Braunstein said.
The drugs, designed to help people in chronic pain from conditions such as arthritis, are known as Cox-2 inhibitors. At least two other Cox-2 drugs are awaiting approval from the FDA, Arcoxia from Merck and Lumiracoxib from Novartis Pharmaceuticals. The panels planned to discuss those drugs Thursday.
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