FDA Warns of Possible Increased Risk of Cancer With Lorcaserin
January 30, 2020   

In 2016, the World Health Organization reported that more than 1.9 billion adults were overweight and of these over 650 million were classified as obese. Overweight and obese patients are at increased risk of developing a host of cardiometabolic diseases and certain cancers, which subsequently increases their risk of death. Therapeutic lifestyle changes, such as a reduced-calorie diet and increased physical activity are often insufficient in achieving weight loss goals. As such, pharmaceutical therapies are being used as adjunctive treatments for obese and overweight patients to achieve and maintain weight loss. Lorcaserin (Belviq and Belviq XR) is one such pharmaceutical drug approved by the Food and Drug Administration (FDA) in 2012 for use in overweight and obese patients with weight-related medical problems. Lorcaserin suppresses appetite by inducing feelings of fullness that result in less food consumption. A serotonin 5HT2c selective agonist, lorcaserin binds to 5HT2c receptors on pro-opiomelanocortin (POMC) neurons in the hypothalamus, activating POMC neurons and the release of a-melanocyte-stimulating hormone (aMSH), which binds to melanocortin 4 receptors (MC4R) to suppress appetite. Clinical trials have shown an average weight loss of 3-4% with lorcaserin versus placebo treatment in obese patients. However, a recent safety clinical trial evaluating the risk of heart-related problems with lorcaserin treatment in approximately 12,000 participants over five years has shown that more patients taking lorcaserin were diagnosed with cancer compared to patients taking placebo. The FDA continues to evaluate these results and is uncertain about the cause of the cancer or if lorcaserin contributes to the risk of cancer. Final conclusions and recommendations will be provided once the review is complete. Health care professionals are encouraged to consider if the benefits of taking lorcaserin are likely to exceed the potential risks when deciding whether to prescribe or continue treating patients with lorcaserin.

Update (February 13, 2020): The FDA has requested that the manufacturer of lorcaserin voluntarily withdraw the drug from the market. The drug manufacturer, Eisai Inc., has submitted a request to voluntarily withdraw the drug.


>> FDA MedWatch Safety Information

>> FDA Drug Safety Communication

>> World Health Organization (WHO) Fact Sheet: Obesity and overweight

Stahl SM. Stahl’s essential pharmacology: neuroscientific basis and practical applications. 4th ed. Cambridge University Press; 2013

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