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Analysis of the CAMELLIA-TIMI 61 trial revealed patients receiving the weight-loss add-on had an increased risk of cancer.
After the US Food and Drug Administration (FDA) issued a Drug Safety Communication concerning their weight-loss add-on lorcaserin (BELVIQ, BELVIQ XR), Eisai Inc. announced they were removing the treatment and lorcaserin would no longer be sold in the US market.
Following an analysis of data from the CAMELLIA-TIMI 61 TRIAL, the agency declared the potential risk of cancer associated with use of the weight-loss add-on outweighed the benefits and asked Eisai Inc to voluntarily withdraw the product.
“As noted in a new Drug Safety Communication issued today, patients should stop using the medication Belviq and Belviq XR (lorcaserin) and talk to their health care professionals about other treatment options for weight loss. Health care professionals should stop prescribing and dispensing Belviq and Belviq XR,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
When lorcaserin was approved in 2012 as an adjunct to help weight loss in adults who are obese or overweight and have weight-related medical problems, the FDA notified Eisai they would need to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the potential for risk of cardiovascular issues. In total, 12,000 participants over 5 years with established cardiovascular disease (CVD) or at high risk for CVD across 400 sites.
The FDA’s analysis of this trial, which is still ongoing, is uncertain if lorcaserin increased the risk of cancer. According to a release from Eisai, 7.7% of patients treated with lorcaserin were diagnosed with cancers compared to 7.1% in the placebo group.
Of note, 1 additional cancer per 470 patients treated with the medication for 1 year was observed. A report from the FDA noted several different types of cancers occurred more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.
“We will continue to track safety issues with medications on the market and use science and data as our guide to act quickly when we have determined that the risks associated with drugs are greater than the benefits of treatment,” Woodcock said.
In the FDA Drug Safety Communication, the agency recommends patients currently on lorcaserin should talk to their health care providers about potential risks of cancer with use of lorcaserin. Additionally, the document noted providers and patients are urged to report side effects involving lorcaserin.