FDA Warns of Possible Cancer Risk for Belviq, BelviqXR Weight Loss Drugs
FDA trial finds possible link between active ingredient lorcaserin and cancer.
Wednesday, January 15, 2020 - An FDA clinical trial revealed a possible link between weight management drugs Belviq, Belviq XR (lorcaserin) and cancer, causing the regulatory agency to issue an alert about the potential risk.
"At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk," the alert reads. "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 was approved by the FDA in 2012 to help adults with weight loss, particularly those who also struggle with weight-related problems like diabetes. It works by making patients feel full so that they eat less.
Originally, the FDA rejected the drug in October 2010 because animal studies indicated cancer signals. Two years later, after reviewing additional data submitted by Eisai Inc., the drug was approved.
The new alert for possible cancer risk came after the FDA asked Eisai Inc. to conduct a double-blind clinical trial to evaluate effects the drug may have on the heart. Approximately 12,000 patients were evaluated over five years. Among the results, the data determined that, compared to the group who received a placebo, a larger percentage of participants were diagnosed with cancer.
"Our evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer," the alert reads.
According to the FDA, healthcare providers are asked to consider whether or not the benefits of lorcaserin outweigh potential risks. Patients should discuss risks with their physician.
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