Drug Safety Alerts

Belviq and Belviq XR Tablets Manufactured by Eisai Market Withdrawal

2/13/2020

On February 13, 2020, the United States Food and Drug Administration (FDA) announced that it had requested that the manufacturer of Belviq® 10 mg tablets NDC # 62856-0529-60 and Belviq XR 20 mg tablets NDC # 62856-535-30 voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. In the announcement, FDA stated that the drug manufacturer, Eisai, has submitted a request to voluntarily withdraw the drug.

On February 18, 2020, Eisai, Inc. issued a withdrawal of Belviq 10 mg tablets and Belviq XR 20 mg tablets. In its notice of withdrawal, Eisai stated that the withdrawal was issued after a request from the U.S. Food and Drug Administration (FDA) based on the Agency’s recently completed analysis of data from the CAMELLIA-TIMI 61 trial. Eisai further stated that following FDA’s review of the data, FDA concluded that the potential risks of lorcaserin outweigh its benefits. Eisai has agreed to voluntarily withdraw the products from the U.S. market.  

The FDA recommends that health professionals stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking Belviq and Belviq XR tablets, 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.

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

When the FDA approved Belviq and Belviq XR tablets in 2012, it 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 Belviq and Belviq XR tablets group, including pancreatic, colorectal, and lung. 

In January 2020, FDA announced it was reviewing clinical trial data and alerted the public about a possible risk of cancer associated with Belviq and Belviq XR tablets based on preliminary analysis of the data. FDA’s February 13 communication is an update to the January communication.

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.

CVS Caremark Response: In response to this withdrawal, CVS Caremark Mail Service Pharmacies will no longer be dispensing Belviq and Belviq XR tablets. To support member safety, CVS Caremark® is sending letters to members who received this product through CVS Caremark® Mail Service Pharmacy and their physicians.

For more information, please contact Eisai Medical Information at 1‑888-274-2378 or visit www.belviq.com. You can also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.