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Belviq withdrawn

Weight-loss drug Belviq withdrawn over fears of cancer occurrence

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

The FDA has requested that Eisai - the manufacturer of Belviq, Belviq XR (lorcaserin) - voluntarily withdraws the weight-loss drug from the US market because a safety clinical trial has showed an increased occurrence of cancer. Eisai has submitted a request to voluntarily withdraw the drug.

“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. 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 assessing safety,” the FDA said on its website.

The FDA approved lorcaserin in 2012 but part of the approval required the drug manufacturer to conduct a randomised, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular problems. Data from the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial, which included 12,000 patients over five years, reported a range of cancer types with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal and lung.

The primary safety analysis showed no meaningful difference between lorcaserin and placebo in the risk of major adverse cardiovascular events, demonstrating noninferiority. The one-sided upper bound of the 95% confidence interval (CI) of the hazard ratio (HR) was less than 1.4 (the noninferiority margin). The HR (95% CI) was 1.005 (0.842, 1.198) for lorcaserin versus placebo.

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.

The FDA has advised that patients should stop taking lorcaserin and talk to their healthcare professionals about alternative weight-loss medicines and weight management programmes. Healthcare professionals should stop prescribing and dispensing lorcaserin to patients and contact patients currently taking lorcaserin, inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine.

FDA is not recommending special screening for patients who have taken lorcaserin. As with any individual patient, regardless of prior lorcaserin treatment, standard screening recommendations for cancer should be implemented.

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