New obesity drug approved by FDA
April 29, 1996
Web posted at: 10:35 p.m. EDT
From Correspondent Jeff Levine
WASHINGTON (CNN) -- The Food and Drug Administration Monday approved the first new prescription diet drug in the United States in more than 20 years. The drug dexfenfluramine, known in the pharmaceutical trade as Redux, was previously available only in Europe. It will be available in the U.S. now for use by patients who are seriously obese -- 30 percent above their desirable weight -- or who have other risk factors, like high blood pressure or diabetes.
Rep. Sam Gejdenson, D-Connecticut, tried for years to lose weight to bring his diabetes under control. He said he was never really successful until six months ago, after he got a prescription for Redux in Europe. He has lost 25 pounds and kept it off.
"The diet has worked. I mean, for the first time in my life, I left food on the plate," Gejdenson said. (237K AIFF sound or 237K WAV sound)
Redux is an appetite suppressant that controls the level of serotonin in the brain. Serotonin is a chemical messenger that makes patients feel full after eating less food.
The drug should be available by prescription in June, and will cost about $2.40 a day. It is considered non-addictive, and is the first obesity drug approved for long-term use in the United States.
The FDA said in one study, Redux helped six out of 10 patients lose a total of 10 percent of their body weight after one year -- compared to only three of 10 patients who followed the same diet and exercise regimen with a dummy pill.
The down side: critics say the drug may cause depression in some people. Studies have shown animals that went off the drug had depleted levels of serotonin, which also affects mood.
"The people I'm worried about are the people who are 5, 10, 20 pounds overweight, who aren't a serious life-and-death risk from that degree of obesity or being overweight," said Dr. Lewis Seiden of the University of Chicago. (170K AIFF sound or 170K WAV sound)
The company that makes Redux, Interneuron Pharmaceuticals, and its distributor, Wyeth-Ayerst Laboratories, contend neurological problems are not a major worry. They say the animals studied were given far greater doses of the drug than people get, and say Redux has been safely used in Europe.
Doctors believe patients will typically stay on Redux for anywhere from three to five years, along with a program of exercise and counseling.
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