September 29, 1995
Web posted at: 1:45 p.m. EDT
From CNN Correspondent Eugenia Halsey
WASHINGTON (CNN) -- Helen Dana has been on countless diets -- only this time she thinks she'll succeed. Why? Because about a month ago, her doctor helped jump-start her new eating and exercise program with a drug called fenfluramine.
"I have lost more weight in that time than I did prior to the prescription medication," she says.
Many other patients have fenfluramine success stories, but the drug is only approved for short-term -- three months -- use. Now, the Food and Drug Administration is considering approving a variation of the drug called dexfenfluramine. It would be the first diet drug approved for long-term use.
And it would be the first new diet pill of any kind approved in the United States in 20 years.
One scientist told an expert panel advising the FDA that obesity is the second leading killer of Americans, behind smoking. It's time, said Judith Stern of the American Obesity Association, to start treating some of the most extreme cases with dietary changes and drugs.
"Drug therapy is a valuable tool, especially for the large numbers of individuals who fail repeatedly to lose weight and to maintain that lost weight," Stern says. (119K AIFF sound or 240K WAV sound)
A Massachusetts-based company called Interneuron is seeking approval of dexfenfluramine. The company says studies have shown the drug, when combined with diet and exercise, helps patients lose up to twice as much weight as they did on other diet plans.
Dexfenfluramine works by boosting levels of serotonin in the brain, which curbs patients' craving for snacks. The result -- they feel full so they eat less.
Side effects such as dry mouth and diarrhea appear to be mild, and -- the company says -- unlike amphetamines, the drug is not addictive.
But one study showed dexfenfluramine caused brain damage when given to monkeys in high doses.
"The concern is the possibility of memory changes, a possibility of mood changes, behavioral changes, and so members of the committee have recommended that specific studies be done to look at this," said FDA panel member Dr. Leo Lutwak. (162K AIFF sound or 323K WAV sound)
Studies have already shown that most patients have to take the drug indefinitely to keep the weight off, and they have to continue dieting and exercising.
And some experts worry about the effect of giving medications to a nation hungry for quick fixes.
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