Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.
On February 13, 2020 FDA requested that the manufacturer of Belviq and Belviq XR (active ingredient lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. 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 drug manufacturer, Eisai Inc. has submitted a request to voluntarily withdraw the drug.
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 your 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.
When FDA approved lorcaserin in 2012, we required the drug manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular problems. The trial was conducted in 12,000 patients over 5 years and found that during the course of the trial, 462 or 7.7 percent of patients treated with lorcaserin were diagnosed with cancer compared to the placebo group, in which 423 or 7.1 percent of patients were diagnosed with cancer. 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.
To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving lorcaserin or other medicines to the FDA MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals, the complete Data Summary and other related information can be found at www.fda.gov/DrugSafetyCommunications.