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Drug Safety Communication: Belviq, Belviq XR (lorcaserin) - Due to Possible Increased Risk of Cancer

January 14, 2020

Audience: Patient, Health Professional, Pharmacy

ISSUE: The 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 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.

BACKGROUND: 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).

RECOMMENDATION: 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.

Patients currently taking lorcaserin should talk to their health care professionals about the potential increased risk of cancer with use of lorcaserin.


Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[01/14/2020 - Drug Safety Communication - FDA]

Source: FDA

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