The FDA's Assessment of Two Drugs for Chronic Weight Management

Food and Drug Administration, Silver Spring, MD, USA.
New England Journal of Medicine (Impact Factor: 55.87). 10/2012; 367(17):1577-9. DOI: 10.1056/NEJMp1211277
Source: PubMed


Owing to a complex interplay among genetic, environmental, and cultural factors, obesity has reached epidemic proportions in the United States. The adverse health consequences of obesity are manifold, potentially involving all major organ systems and contributing to reduced quality of life. The goal of all obesity therapies is negative energy balance. Drugs have long been used in an attempt to achieve this goal. However, numerous once-promising weight-loss drugs have been abandoned because of serious toxic effects: aminorex (which caused pulmonary hypertension), fenfluramine and dexfenfluramine (valvulopathy), phenylpropanolamine (stroke), rimonabant (suicidal ideation and behavior), and most recently sibutramine (myocardial infarction and stroke). . . .

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    ABSTRACT: Oral lorcaserin (Belviq®), a novel selective serotonin 5-HT2C receptor agonist, is indicated in the USA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management of obese adults, or overweight adults with at least one weight-related co-morbidity. In 12-month clinical studies, lorcaserin was more effective than placebo in reducing weight in obese or overweight adults with or without type 2 diabetes mellitus. It is well tolerated and does not appear to be associated with an increased risk of valvulopathy.
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