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October 12, 1994

Obesity Drug Renews Toxicity Debate

JAMA. 1994;272(14):1087-1088. doi:10.1001/jama.1994.03520140017007

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THE DISPUTE has been going on for decades: What criteria should researchers and regulators use to judge whether compounds with therapeutic potential are, in reality, neurotoxic?

If the controversy is settled in the near future, it may be thanks to dexfenfluramine, an amphetamine derivative now being evaluated by the Food and Drug Administration (FDA) as an appetite suppressant. Interneuron Pharmaceuticals Inc, Lexington, Mass, which sponsored dexfenfluramine's new drug application with the FDA, calls it an antiobesity drug.

The stakes for dexfenfluramine's approval are high. Given the increase in overweight Americans and the nation's obsession with being thin, new weight control medications that are effective and nonaddicting face an immense commercial market. One FDA official says dexfenfluramine has been referred to as "the $5-billion drug."

There's just one catch. A handful of researchers have published animal studies that they say raise a red flag. They say that their data show evidence

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