Is lorcaserin (Belviq, Belviq XR) effective in the treatment of obesity, and what is its current status?

Updated: Jun 09, 2021
  • Author: Osama Hamdy, MD, PhD; Chief Editor: Romesh Khardori, MD, PhD, FACP  more...
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Answer

On February 13, 2020, the FDA requested that lorcaserin be voluntarily withdrawn from the market by its manufacturer owing to a clinical trial indicating that the drug carries an increased cancer risk. For more information, see the FDA Drug Safety Communication. [156]

Lorcaserin was approved by the FDA in June 2012 as an adjunct to a reduced-calorie diet and exercise for long-term weight management in individuals with an initial BMI of 30 kg/m2 or higher (obese) or 27 kg/m2 or higher (overweight) with at least 1 weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes mellitus). [157] Lorcaserin is a schedule IV substance, since it has potential for abuse. [158]

Lorcaserin is thought to decrease food consumption and promote satiety by selectively activating 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons in the hypothalamus. Approval of lorcaserin was based on 3 double-blind, randomized, placebo-controlled trials that found lorcaserin (along with diet and exercise) to be more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after 1 year and managing the weight loss for up to 2 years. [159, 160, 161]

Required postmarketing studies of lorcaserin will include a long-term trial to assess the risk for major adverse cardiac events. Lorcaserin should be used with caution in patients with heart failure, and it has not been studied in patients with serious valvular heart disease. [157]


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