The US Food and Drug Administration (FDA) has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the United States market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc., has submitted a request to voluntarily withdraw the drug.
FDA is taking this action because it believes that the risks of lorcaserin outweigh its benefits based on FDA’s completed review of results from a randomized clinical trial assessing safety.
In January 2020, FDA announced it was reviewing clinical trial data and alerted the public about a possible risk of cancer associated with lorcaserin based on preliminary analysis of the data. 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 percent) were diagnosed with cancer compared to those taking a placebo, which is an inactive treatment (n=423; 7.1 percent). 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.
Patients should stop taking lorcaserin and talk to their health care professionals about alternative weight-loss medicines and weight management programs.
Health care professionals should stop prescribing and dispensing lorcaserin to patients. 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. Discuss alternative weight-loss medicines or strategies with their patients. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 15 Jan 2020.
Ends/Friday, Feb 14, 2020
Issued at HKT 15:00
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