FDA has required the withdrawal of the weight-loss drug Belviq from the market: potential risk of cancer outweighs the benefits
The FDA ( U.S. Food and Drug Administration ) has requested that the manufacturer of Belviq, Belviq XR ( Lorcaserin ) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer.
The drug manufacturer, Eisai, has submitted a request to voluntarily withdraw the drug.
According to FDA the risks of Lorcaserin outweigh its benefits based on completed review of results from a randomized clinical trial assessing safety.
In January 2020, FDA has alerted the public about a possible risk of cancer associated with Lorcaserin based on preliminary analysis of the data.
Patients should stop taking Lorcaserin and talk to health care professionals about alternative weight-loss medicines and weight management programs.
FDA is not recommending special screening for patients who have taken Lorcaserin.
Health care professionals should stop prescribing and dispensing Lorcaserin to patients.
When FDA approved Lorcaserin in 2012, FDA required the drug manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular problems, which found that more patients taking Lorcaserin ( n=462; 7.7% ) were diagnosed with cancer compared to those taking a placebo, which is an inactive treatment ( n=423; 7.1% ). The trial was conducted in 12,000 patients over 5 years.
A range of cancer types was reported, with several different types of cancers occurring more frequently in the Lorcaserin group, including pancreatic, colorectal, and lung.
FDA has reviewed data from the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 ( CAMELLIA-TIMI 61 ) clinical trial. It was 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. Approximately 96% of patients completed the study, and 62% who completed remained on treatment at the end of study.
The median follow-up time was 3 years and 3 months.
The primary safety analysis showed no meaningful difference between Lorcaserin and placebo in the risk of major adverse cardiovascular events, demonstrating non-inferiority.
The one-sided upper bound of the 95% confidence interval ( CI ) of the hazard ratio ( HR ) was less than 1.4 ( the non-inferiority 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% ) patients treated with Lorcaserin were diagnosed with 520 primary cancers compared to the placebo group, in which 423 ( 7.1% ) 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. ( Xagena )
Source: FDA, 2020