The Food and Drug Administration (FDA) has requested that the manufacturer of lorcaserin (Belviq, Belviq XR), a serotonin 2C receptor agonist used as an adjunct to diet and exercise for weight loss, voluntarily withdraw the drug from the U.S. market. This request follows the finding of an increased occurrence of cancer in a safety clinical trial. The drug's manufacturer, Eisai Inc., has since submitted a request to voluntarily withdraw the drug.

When lorcaserin was approved in 2012, the FDA required Eisai to conduct a clinical trial to determine the risk of heart-related problems. The randomized, double-blind, placebo-controlled trial was conducted in 12,000 patients over five years. The trial found that more patients taking lorcaserin were diagnosed with cancer than patients taking placebo.

NPs and other clinicians should stop prescribing and dispensing lorcaserin and discuss alternative weight-loss treatments or strategies with their patients. Patients should be told to stop taking the drug and, if possible, to dispose of it at a drug take-back location.

To read the updated FDA Drug Safety Communication regarding the FDA's request for lorcaserin withdrawal, go to http://www.fda.gov/media/135189/download.