CNN Food and Health

Obesity drug takes big step toward final FDA approval

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November 17, 1995
Web posted at: 10:30 a.m. EST

From Correspondent Eugenia Halsey

WASHINGTON (CNN) -- A Food and Drug Administration panel has recommended approval for sale in the United States of the first new anti-obesity drug in more than two decades.

The panel on Thursday recommended that Interneuron Pharmaceuticals Inc. be allowed to market the drug, dexfenfluramine.

One of those already benefiting from the drug is Dick Titus of Reston, Virginia. In just six months, Titus has lost 45 pounds through exercise, diet, and diet pills.

The pill Titus has been taking is a prescription diet drug called pondimin or fenfluramine. It's a chemical relative of the dexfenfluramine, the drug the FDA has been considering approving for longer periods. Right now, Titus' medication is only approved for a few months use and may not be as effective as dexfenfluramine.

Already approved in 65 countries, dexfenfluramine would be marketed in the United States by Interneuron. The drug works by increasing levels of serotonin in the brain, making patients feel full sooner, so they eat less food. Unlike other diet drugs available, dexfenfluramine is not addictive and has few side effects. But not everyone loses weight with it. And patients usually regain the weight if they go off the drug.

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At a meeting of an FDA advisory committee, company board member Alexander Haig said the drug helps twice as many people lose 10 percent of their weight as a dummy pill. Haig says ten million people have used the drug without side effects. (58K AIFF sound or 55K WAV sound)

Currently, obesity contributes to 300,000 deaths a year in the United States. When someone is overweight, they are at an increased risk for disease and death. According to Judith Stern of the American Obesity Association, the prospect of saving lives is one reason the FDA should approve the drug. (108K AIFF sound or 108K WAV sound)

But not everyone is eager to see dexfenfluramine approved. Reports of brain damage in animals given very high doses of the drug have members of the Council on Size and Weight Discrimination worried.

"This drug is not the last, the only hope for fat people," says Lyn McAfee. "It may be that the safety concerns will be resolved someday. But that day is not today." (108K AIFF sound or 108K WAV sound)

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Still, Interneuron defended dexfenfluramine's record by saying the drug has a large margin of safety. In Thursday's decision, the FDA panel, on a 6-to-5 vote, agreed to recommend that the agency approve dexfenfluramine. However, it would like to see more studies of the drug's long-term effects. Although the drug has not won final FDA approval, the agency usually follows the recommendation of the review panel.

Interneuron says dexfenfluramine could be available in the United States as soon as soon as the approval goes through. That means people trying to lose large amounts of weight may soon have another aid to consider.



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