The U.S. Food and Drug Administration (FDA) is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and FDA cannot conclude that lorcaserin contributes to the cancer risk. However, regulator wanted to make the public aware of this potential risk. FDA is continuing to evaluate the clinical trial results and will communicate final conclusions and recommendations when the review will be completed.
Lorcaserin is a prescription medicine approved by FDA in 2012 for use with a reduced-calorie diet and increased physical activity to help weight loss in adults who are obese or are overweight and have weight-related medical problems. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and an extended-release tablet (Belviq XR).
When approving lorcaserin, FDA required the drug manufacturer, Eisai Inc., to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems. In this trial, which was conducted in approximately 12,000 participants over 5 years, more patients taking lorcaserin were diagnosed with cancer compared to patients taking placebo, which is an inactive treatment. Evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer.