FDA Says Weight-Loss Drugs Belviq®, Belviq XR® (lorcaserin) Possibly Linked to Cancer

The U.S. Food and Drug Administration (FDA) issued a warning that the weight management drugs Belviq® and Belviq XR® (lorcaserin) may increase the risk of cancer.

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” the FDA said in its warning letter.

The agency said healthcare professionals should consider if the benefits of taking lorcaserin are likely to exceed the potential risks when deciding whether to prescribe or continue patients on lorcaserin.

Follow-up trial showed greater risk of cancer

When the drug was approved, the FDA required the manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems. In this trial that included about 12,000 patients over a five-year period, more patients receiving lorcaserin were diagnosed with cancer compared with those taking placebo.

Lorcaserin is a serotonin 2C receptor agonist that was approved in 2012 for use in combination with a reduced-calorie diet and increased physical activity to improve weight loss in adults who are obese or overweight and have at least one weight-related medical condition. In 2016, the FDA approved a new drug application for an extended-release, once-daily formulation of lorcaserin.