Last reviewed: June 2020
Last updated: January  2020
14 Feb 2020

FDA requests withdrawal of lorcaserin from the market

The 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.

See Management: approach

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History and exam

Other diagnostic factors

  • waist circumference
  • comorbid conditions

Risk factors

  • hypothyroidism
  • hypercortisolism
  • age ≥40 years
  • peri- and postmenopause
  • prior pregnancy
  • married
  • 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

Diagnostic investigations

Investigations to consider

  • CBC
  • serum aminotransferases
  • thyroid function tests
  • ECG
  • abdominal ultrasound scan
  • polysomnography (sleep study)
More investigations to consider

Treatment algorithm


Constantine T. Frantzides

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.

Minh B. Luu

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.

Peer reviewersVIEW ALL

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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