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Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

FDA Drug Safety Podcast


Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. On January 14, 2020, FDA alerted 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 (active ingredient lorcaserin). 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.

Health care 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. Lorcaserin was approved by FDA in 2012 for use with a reduced-calorie diet and increased physical activity to help with weight loss in adults who are obese or are overweight and have weight-related medical problems.

When approving lorcaserin, we required the drug manufacturer, Eisai Inc., to conduct a clinical trial to evaluate the risk of heart-related problems. In this trial, more patients taking lorcaserin were diagnosed with cancer compared to patients taking placebo. At this time, it is uncertain if lorcaserin increases the risk of cancer.

Side effects involving lorcaserin or other medicines should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

A link to the full communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov. And follow us on Twitter @FDA_Drug_Info.

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