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FDA panel to review 'super aspirin'

graphic December 1, 1998
Web posted at: 12:50 a.m. EST (0550 GMT)

(CNN) -- A U.S. Food and Drug Administration advisory panel will review on Tuesday a new class of pain relievers that may free those who take aspirin-type drugs from their painful side effects.

People who often must take pain relievers, such as arthritis sufferers, would be among those who could benefit the most from the experimental Cox-2 inhibitors.

Gloria Baswell, who suffers chronic pain from rheumatoid arthritis, took aspirin and similar non-steroidal anti-inflammatory drugs for at least nine years, she said, "and they really did a job on my stomach. To this day, I can't even take an aspirin."

Cox-2 inhibitors promise to treat the pain without hurting the stomach. The one the FDA review on Tuesday is Celebra, manufactured by Searle-Monsanto.

Some have touted the Cox-2 inhibitors as "super aspirin" -- not for what they do, but for what they don't do.

"To call them a super aspirin is probably not correct, in the sense that they're not stronger than the aspirins we have," said Dr. Thomas Schnitzer of Northwestern University. "They're equally good at pain relief, but what they are certainly super about it is they're super safe."

Cox-1 is an enzyme the stomach needs to protect itself. Another enzyme, Cox-2, triggers pain and inflammation when a person is hurt. Aspirin-like drugs block both Cox-1 and Cox-2, reducing pain, but also causing side effects like ulcers. The new drugs block only Cox-2, providing pain relief without stomach trouble.

Not all doctors are convinced the Cox-2 inhibitors are better than the old aspirin-like drugs.

"It's a little bit premature to be declaring victory until we've had a large enough number of clinical trials and enough people treated for long periods of time to understand the risk-to-benefit ratio better," said Dr. Charles Hennekens of Boston's Brigham and Women's Hospital.

The FDA could review early next year another Cox-2 inhibitor, Vioxx, made by Merck.

Medical Correspondent Rhonda Rowland contributed to this report.

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