The FDA on Tuesday issued a safety alert for the serotonin receptor agonist lorcaserin, warning that results from a clinical trial assessing safety show a possible increased risk for cancer with the weight-management medicine, according to an agency press release.
“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk,” the FDA stated in the release. “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.”
Lorcaserin (Belviq, Eisai) was approved by the FDA in 2012 for use with a reduced-calorie diet and increased physical activity to facilitate weight loss in adults with overweight or obesity with weight-related comorbidities. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet and an extended-release tablet (Belviq XR).
As Healio previously reported, findings from the CAMELLIA-TIMI 61 study demonstrated that treatment with lorcaserin yielded sustained weight loss during a median follow-up of 3 years without an excess risk for major adverse cardiovascular events among adults with overweight or obesity at high CV risk. In the randomized, double-blind, placebo-controlled trial of more than 12,000 patients with atherosclerotic CVD or multiple CV risk factors, researchers also found no increased risk for new or worsening valvulopathy among patients assigned lorcaserin compared with placebo, which has been a concern with other weight-loss drugs.
In this trial, more patients taking lorcaserin were diagnosed with cancer compared with patients taking placebo, the FDA stated.
“Our evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer,” the FDA stated in the release.
In the safety alert, the FDA stated that health care professionals should consider whether the benefits of taking lorcaserin are likely to exceed the potential risks when deciding to prescribe or continue patients on the drug. Patients currently taking lorcaserin should talk to their health care professionals about the potential increased risk for cancer with use of lorcaserin. – by Regina Schaffer