Drug Safety Alerts

Belviq®, Belviq XR Drug Safety Communication

1/14/2020

On January 14, 2020, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication to alert 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 the FDA has stated that it cannot conclude that lorcaserin contributes to the cancer risk. However, the FDA advised that it wanted to make the public aware of this potential risk and that it is continuing to evaluate the clinical trial results and will communicate its final conclusions and recommendations when it has completed its review.

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).

The FDA is advising health care professionals to consider if the benefits of taking lorcaserin are likely to exceed the potential risks when deciding whether to prescribe or continue patients on lorcaserin. The FDA is advising patients currently taking lorcaserin to discuss this issue with their healthcare professional. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA.

CVS Caremark® Response:

Please note: These products have not been recalled. CVS Caremark® Mail Service Pharmacy will continue to dispense Belviq and Belviq XR tablets.

If you would like more information about this issue, please call the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.