The US Institute of Medicine has issued a report on obesity, which includes recommendations to the drug sponsors and the US Food and Drug Administration on points to be considered when judging the efficacy of drugs used to treat the disorder. The FDA has been reviewing its guidelines for anti-obesity drugs, but is still in the early stages of its efforts, with public discussion of the issue slated for early 1995.
Anti-obesity drugs should be considered effective when their use, in combination with a sound program of diet and exercise, results in - achievement of weight loss of at least 5% of initial body weight and maintenance of that loss; - reduced body weight through a reduction of body fat with a sparing of body protein; - reduction of comorbidities (eg hypertension, hyperglycemia, and dyslipidemias); and - minimal or tolerable side effects and a low level of abuse potential.
Anti-obesity drugs are potentially enormous money spinners. The report estimates that annual health care costs of obesity in the USA are $70 billion, and to this figure can be added the more than $33 billion spent each year on weight reduction products.
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