Weight-Loss drug lorcaserin withdrawn from market after FDA warning of cancer risk
USA: The US Food and Drug Administration (FDA) has requested the manufacturer of Belviq (lorcaserin) to voluntarily withdraw the weight-loss drug from the U.S. market. The warning was issued after a safety clinical trial showed an increased occurrence of cancer associated with the use of lorcaserin. Following the warning, the drug manufacturer Eisai Inc has submitted a request to voluntarily withdraw the drug.
Lorcaserin was approved by the FDA in 2012 for use with a reduced-calorie diet and increased physical activity to facilitate weight loss in adults with overweight or obesity and weight-related comorbidities. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet and an extended-release tablet.
"We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial. In January 2020, we announced we were reviewing clinical trial data and alerted the public about a possible risk of cancer associated with lorcaserin based on preliminary analysis of the data," according to FDA'S safety communication.
According to the FDA, the patients should stop taking lorcaserin and talk to their health care professionals about alternative weight-loss medicines and weight management programs.
FDA is not recommending special screening for patients who have taken lorcaserin.
This was based on findings from the (CAMELLIA-TIMI 61) clinical trial -- a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial conducted between January 2014 and June 2018 in the U.S., Canada, Mexico, the Bahamas, Europe, South America, Australia, and New Zealand. The study population consisted of 12,000 men and women who were overweight or obese. Patients were required to have either established cardiovascular disease or to be at least 50 years old for men or 55 years for women with type 2 diabetes mellitus plus at least one additional cardiovascular risk factor. Eligible patients were assigned randomly to either lorcaserin 10 mg twice daily or placebo.
Key findings of the trial include:
· The primary safety analysis showed no meaningful difference between lorcaserin and placebo in the risk of major adverse cardiovascular events, demonstrating noninferiority.
· There was a numerical imbalance in the number of patients with malignancies, with one additional cancer, observed per 470 patients treated for one year.
· During the course of the trial, 462 (7.7 percent) patients treated with lorcaserin were diagnosed with 520 primary cancers compared to the placebo group, in which 423 (7.1 percent) patients were diagnosed with 470 cancers.
· Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases.
· There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin.
"Our evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer," the FDA stated in a release.