The FDA is urging physicians to weigh the benefits and risks of the obesity drug, Belviq™ (lorcaserin), when deciding to start or continue treatment.
The US Food and Drug Administration (FDA) issued a safety alert last Tuesday, January 14, 2020, warning that results from a clinical trial to assess cardiovascular safety showed a possible increase in cancer risk with the obesity medication, Belviq™ (lorcaserin) and its extended-release formula.
“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk,” said the FDA in the alert. “However, we wanted to make the public aware of this potential risk.”
When deciding whether to prescribe or continue patients on the weight loss drug, the FDA says physicians should consider if the benefits of taking lorcaserin exceed the potential risks.
Lorcaserin was approved in 2012 to aid in weight loss in obese or overweight adults with weight-related comorbidities in combination with a calorie-restricted diet and increased exercise.
During the approval process, the drug manufacturer, Eisai Inc., conducted an FDA-required clinical trial assessing the cardiovascular safety of the serotonin 2C receptor agonist lorcaserin.
The randomized, double-blind, placebo-controlled study examined approximately 12 000 participants over 5 years and found that more patients taking lorcaserin were diagnosed with cancer vs patients taking placebo.
“We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” said the FDA in the release.
In the meantime, the FDA is urging physicians and patients to report side effects involving lorcaserin to the FDA MedWatch program.