New Safety Warning Regarding Belviq and Belviq XR

January 14, 2020 – The U.S. FDA has issued a safety communication regarding Arena Pharmaceuticals’ Belviq® (lorcaserin) and Belviq® XR (lorcaserin extended release). According to the agency, these drugs may increase patients’ risk of cancer. The new warning is based on the results of a clinical study performed to assess the safety of Belviq and Belviq XR.

Both medications are FDA approved to provide chronic weight management in combination with a reduced-calorie diet and increased physical activity in adults who have an initial body mass index (BMI) of 30kg/m 2 or greater. The drugs are also indicated for use in adults who have a BMI of at least 27kg/m 2 in addition to one or more weight-related conditions, such as hypertension or type 2 diabetes. The active ingredient in Belviq and Belviq XR, lorcaserin, works by promoting a feeling of fullness to help patients consume less food.

The FDA advises healthcare professionals to consider the risks and benefits before prescribing Belviq or Belviq XR to patients or deciding to continue treatment with either product. Patients should speak to their healthcare provider about the risks. At this time, the FDA is not advising any further course of action, as the source of cancer in the trials is unclear. The agency will continue to evaluate the trial results and provide final conclusions and recommendations once review of the results has been completed.

The full safety communication can be viewed on the FDA’s website.