title: Safety assessment of FDA-approved (orlistat and lorcaserin) anti-obesity medications.
abstract: BACKGROUND
  Options for treating obesity remain limited despite it being a chronic, recurrent and morbid condition. New drugs that are proposed for its treatment encounter strong reluctance by regulatory agencies and many doctors.
  
  
  METHODS
  This review will focus on the safety of an older drug, orlistat (the only one still approved in the European Union) and a newer recently FDA-approved one, lorcaserin. Both are approved as long-term monotherapy for obesity in the United States of America and they have demonstrated median weight loss of nearly 3% over placebo.
  
  
  CONCLUSIONS
  Research, development and approval of new anti-obesity drugs are necessary for improved management of this chronic condition. Orlistat and lorcaserin are two FDA-approved drugs with limited overall efficacy. Nevertheless they are useful weapons for at least some obese individuals. Orlistat has a long and solid safety profile, whereas the safety of lorcaserin is still a matter of debate, mainly due to a lack of long-term data. However, lorcaserin's selective agonism on 5HT2c serotonin receptors diminishes concerns about valvulopathy associated with other serotonin agonists, such as fenfluramine.
authors.affiliation: Hospital das Clínicas da Universidade de São Paulo, Department of Endocrinology and Metabology, Obesity Group , 462 cj 72-73, 7h floor, São Paulo-SP, CEP 05410-000 , Brazil brunohalpern@hotmail.com.
authors.forename: Bruno
authors.initials: B
authors.lastname: Halpern
authors.forename: Alfredo
authors.initials: A
authors.lastname: Halpern
mesh_terms: D019440:Anti-Obesity Agents / Q000009:adverse effects*; D001552:Benzazepines / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury; D004347:Drug Interactions; D006349:Heart Valve Diseases / Q000139:chemically induced; D006801:Humans; D007783:Lactones / Q000009:adverse effects*; D008286:Malabsorption Syndromes / Q000139:chemically induced; D009369:Neoplasms / Q000139:chemically induced; D000077403:Orlistat; D020230:Serotonin Syndrome / Q000139:chemically induced; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D019440:Anti-Obesity Agents; D001552:Benzazepines; D007783:Lactones; C506658:lorcaserin; D000077403:Orlistat
keywords: lorcaserin; obesity; orlistat; regulatory agencies; valvulopathy