Due to signals in safety clinical trials showing possible increased risk of cancer, The U.S. Food and Drug Administration (FDA) requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market. The drug manufacturer, Eisai Inc, has submitted a request to voluntarily withdraw the drug and Eisai Inc. announced that it will comply with voluntarily withdrawing Belviq from the market and discontinuing sales in the U.S.
The safety signal arose from analysis of CAMELLA-TIMI 61, a randomized, double-blind, placebo-controlled cardiovascular outcome trial over five years of adults with obesity and high risk of, or established, atherosclerotic cardiovascular disease. The FDA review found that slightly more patients taking lorcaserin (n=462; 7.7 percent) were reportedly diagnosed with cancer compared to those taking a placebo, (n=423; 7.1 percent). The 0.6% absolute risk increase did not include a reported confidence interval but calculates out to about a relative risk of 1.09, p=0.1733 and number needed to harm of 154. The FDA concluded that these potential risks outweigh the benefits of lorcaserin recommending patients stop taking lorcaserin and discussing alternative therapies with their physicians. No specific cancer screening is recommended and a range of cancer types were reported including pancreatic, colorectal, and lung.
It should be noted that this concern and withdrawal does NOT pertain to other obesity or weight loss therapies.
Eisai Belviq website - Additionally, patients and health care providers with questions can contact Eisai Medical Information at: [email protected] or 1-888-274-2378