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

After weighing the risks and benefits, the FDA recently approved two new drugs as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management in obese or overweight adults with at least one weight-related coexisting condition. 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). . . .