SCIENTISTS UPSET OVER REDUX SIDE EFFECTS


Associated Press
Sunday, April 20, 1997 ; Page A6

WASHINGTON (AP) - One year after the drug Redux revolutionized obesity treatment, scientists demand to know why the government let it sell so long without studying a possible brain-damaging side effect.

The critics fear the potent drug is inappropriately prescribed to many Americans, and an Associated Press examination of government records found a 120-pound Redux patient who died inexplicably.

"Make sure you are aware of what the potential side effects are," warns Dr. George Ricaurte of Johns Hopkins University, who is beginning to measure patients' brains to see if they show damage similar to that suffered by animals fed the drug.

Redux was hailed as a wonder drug when the Food and Drug Administration approved it last April. It stimulates production of the brain chemical serotonin, believed vital for mood and other functions, to essentially fool people into feeling fuller.

For many patients, it has worked.

But Redux is not for those who simply wish to shed a few pounds. The FDA insists only the severely obese try it, because Redux users have 23 times the average risk of a rare but often fatal lung ailment called primary pulmonary hypertension.

Also, the FDA approved Redux on the condition that manufacturer Wyeth-Ayerst study whether it damages the human brain cells that produce serotonin. Previous studies in mice, rats, monkeys and baboons show high doses destroy those cells - raising fears of repercussions like depression if the same thing happens to people.

One year later, Wyeth-Ayerst hasn't started that study.

Articles appear as they were originally printed in The Telegraph Herald and may not include subsequent corrections.

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