Drug Safety Communication: Belviq, Belviq XR (lorcaserin) by Eisai - FDA Requests Withdrawal of Weight-Loss Drug
Audience: Patient, Health Professional, Pharmacy
ISSUE: FDA 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 Inc,. has submitted a request to voluntarily withdraw the drug.
When FDA approved lorcaserin in 2012, we required the drug manufacturer to conduct a clinical trial to evaluate the risk of cardiovascular problems. 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.
BACKGROUND: In January 2020, FDA 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.
Patients should stop taking lorcaserin and talk to your health professionals about alternative weight-loss medicines and weight management programs. It is best to dispose of unused lorcaserin using a drug take back location, but if you can’t get to one you can dispose of lorcaserin in your household trash:
- Mix the pills with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.
- Place the mixture in a container such as a sealed plastic bag.
- Throw away the container in your trash at home.
- Remove or delete all personal information on the prescription label of empty medicine bottles or packaging, then throw away or recycle them.
FDA is not recommending special screening for patients who have taken lorcaserin. Talk to your health care professional if you have questions.
Health 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.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form or submit by fax to 1-800-FDA-0178
[02/13/2020 - Drug Safety Communication - FDA]
[01/14/2020 - Drug Safety Communication - FDA]
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