The U.S. Food & Drug Administration (FDA) is investigating a possible link between the weight loss drug Belviq and an increased risk of cancer.
Belviq and Belviq XR (lorcaserin) are indicated for use with a low-calorie diet to aid weight loss in obese adults who suffer from weight-related health problems. The FDA approved Belviq in 2012, while Belviq XR (an extended release version of lorcaserin) was approved in 2016.
Lorcaserin was initially developed by Arena Pharmaceuticals, but Esai, Inc. held the rights to market the drugs in the United States. Esai went onto acquire the global rights to market Belviq and Belviq XR in 2017.
The FDA actually declined to approve Belviq upon Arena’s first attempt in 2010 because research involving rats had suggested a link to cancer. However, the agency later concluded that the tumors were specific to the animals.
When Belviq was finally approved in 2012, the FDA required the manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems associated with its use. In a Drug Safety Communication issued yesterday, the agency disclosed that the trial – which involved approximately 12,000 participants over 5 years – saw more cases of cancer among participants receiving Belviq compared to those receiving a placebo.
“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk,” the FDA stated. “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.”
In the meantime, the agency is urging healthcare providers to consider whether the benefits of Belviq outweigh its potential risks when deciding whether to prescribe the drug.
Patients who are currently taking Belviq or Belviq XR should discuss the potential increased risk of cancer in order to make the best decision about their medical treatment.
Finally, the FDA is asking patients and healthcare providers to report any adverse events potentially associated with Belviq to the Medwatch program, either through the agency’s online portal, by submitting a downloadable form, or by calling 1-800-332-1088 to request form.