In the final report, the risk was calculated to be about 23 times higher for patients using anorexigens for 3 or more months compared to non-users. The incidence of PPH for patients taking anorexigens, including Redux, is now estimated to be between 23 and 46 cases per million patients per year. Therefore, it is very important that Redux not be prescribed for cosmetic weight loss. As indicated in the current labeling, patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope, or lower extremity edema.
Obesity is a serious medical problem in the United States.
Redux, combined with a reduced-calorie diet, is indicated for the management of obesity, including weight loss and maintenance of that weight loss. In clinical trials, Redux helped produce a significant reduction in weight during the first 4 to 6 months, and that loss was maintained during the year-long therapy. The safety and effectiveness of Redux beyond one year have not been determined. Redux should not be administered to patients using other serotonergic drugs. Redux is not recommended for women who are pregnant or nursing or for pediatric patients.