US FDA requests withdrawal of lorcaserin from the market
The US Food and Drug Administration (FDA) has requested that the manufacturer of lorcaserin voluntarily withdraw the weight-loss drug from the US market because of safety concerns with the drug. In response, the manufacturer has submitted a request to voluntarily withdraw the drug.
A randomized, double-blind, placebo-controlled trial conducted in 12,000 patients over 5 years found that more patients taking lorcaserin were diagnosed with cancer compared to those taking placebo (7.7% of patients on lorcaserin versus 7.1% of patients on placebo). Pancreatic, colorectal, and lung cancer were reported more frequently in the lorcaserin group.
Health care professionals are advised to stop prescribing and dispensing lorcaserin, and to contact patients currently taking the drug to inform them of the risk. Patients are advised to stop taking the drug, safely dispose of it, and talk to their health care professional about alternative treatments.
The FDA is not recommending any special screening for patients who have taken lorcaserin.
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Presentation of obesity may range from asymptomatic to presentation complicated by multiple comorbidities, including cancer, coronary artery disease, diabetes, hypertension, gout, obstructive sleep apnoea, and osteoarthritis.
The definitive test for the diagnosis of obesity remains the body mass index (BMI; obesity is defined as a BMI ≥30 kg/m²).
Central or abdominal obesity has a stronger association with obesity-related comorbidity than peripheral (i.e., subcutaneous) obesity, so waist circumference may be a better indicator of the risk for obesity-related comorbidity than BMI.
The mainstay of non-surgical treatment of obesity is diet and exercise, with psychological therapy as a recommended adjunct for all patients. The risk of complications is low, but the overall efficacy and durability of this combination is poor.
Drug therapy may be considered as an adjunct to diet and exercise (never as monotherapy) for patients with a BMI ≥30 kg/m². Pharmacotherapy has modest short-term efficacy but a high attrition rate and a lack of long-term efficacy.
Surgical treatment is an option for patients with BMI ≥40 kg/m², or ≥35 kg/m² with significant comorbidities. In general, weight-reductive surgery works through manipulation of the stomach or small bowel, or a hybrid of both. Potential complications are numerous.
Obesity can be defined as a chronic adverse condition due to an excess amount of body fat. While there are many methods to determine the relative amount of body fat, the most widely used method to determine obesity is the body mass index (BMI), defined as weight divided by height squared ([weight in kg]/[height in m]²).
History and exam
- age ≥40 years
- peri- and postmenopause
- prior pregnancy
- sleep deprivation
- history of tobacco smoking
- less formal education
- poor in utero nutrition
- low socioeconomic status
- sedentary lifestyle
- television watching and video games >2 to 3 hours daily
- diet high in sugar, cholesterol, fat, and fast food
- heavy alcohol intake (>2 drinks per day)
- binge-eating disorder
- night eating syndrome
- leptin deficiency
- corticosteroid therapy
- antidepressant therapy
- antipsychotic therapy
- beta-blocker therapy
- adjuvant breast cancer therapy
- psychiatric diagnosis
Director, Chicago Institute of Minimally Invasive Surgery (CIMIS)
Director, Laparoscopic and Bariatric Fellowship Program
Clinical Professor of Surgery, University of Illinois
CTF declares that he has no competing interests.
Site Director, General Surgery Residency Program
Elmhurst Memorial Healthcare
Adjunct Associate Professor of Surgery
Department of General Surgery
Rush University Medical Center
MBL declares that he has no competing interests.
Dr Constantine T. Frantzides and Dr Minh B. Luu would like to gratefully acknowledge Dr Scott N. Welle and Dr Mark A. Carlson, previous contributors to this topic.
Consultant in Metabolic Medicine
Imperial College London
Charing Cross Hospital
CLR declares that he has no competing interests.
Professor of Medicine
Chair for Obesity Research & Management
University of Alberta
Royal Alexandra Hospital
AMS declares that he has no competing interests.
Chair in Surgery
Division of Gastrointestinal and Endocrine Surgery
University of Texas
Southwestern Medical Center
EHL declares that he has no competing interests.
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