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A manilla envelope labeled FDA - FOOD AND DRUG ADMINISTRATION
Childers, Schlueter & Smith
(800) 641-0098

Promising weight-loss drug Belviq has been pulled off the U.S. market due to the potential risk of cancer. At the request of the U.S. Food and Drug Administration (FDA), drug manufacturer Eisai Inc. has voluntarily withdrawn and discontinued sales of Belviq (lorcaserin). The FDA took action due to clinical trials showing an increased risk of cancer in patients who have taken the drug.

The FDA alerted the public in January 2020 about a possible risk of cancer associated with Belviq based on initial safety clinical trial data. Now that the FDA has completed its analysis of the data, it has determined the risks of taking Belviq outweigh its benefits and requested that the manufacturer remove Belviq and Belviq XR, an extended-release version of the drug, from the market. 

Patients should stop taking Belviq and Belviq XR and dispose of any unused medicine. Health care professionals need to stop prescribing and dispensing the medicine and should contact patients currently taking the drug to inform them of the increased occurrence of cancer seen in the clinical trial.

While the FDA is not recommending special cancer screening for patients who have taken Belviq, they are advising patients to talk to their health care professionals about alternative medicines or weight-loss strategies to replace Belviq.

Belviq was approved by the FDA in 2012. As part of the approval process, the drug manufacturer had to conduct a clinical trial to evaluate the risk of heart problems in patients taking the weight-loss drug. The safety trial was conducted in 12,000 patients over 5 years. The trial did not show a risk of heart problems, but after further analysis, it showed 7.7% of participants who took Belviq were diagnosed with cancer, slightly more than the 7.1% who developed cancer in a comparison group who took a fake pill. A range of cancer types was reported, with several different types of cancers occurring more frequently in the Belviq group, including pancreatic, colorectal and lung.

The drug manufacturer’s interpretation of the data from the clinical trial differs from that of the FDA. Eisai Inc.’s assessment is that Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated. However, it respects the decision of the FDA and is pulling the drug from the market.

If you or a loved has taken Belviq (lorcaserin) and developed cancer, please contact the attorneys at Childers, Schlueter & Smith at 800-641-0098 or fill out our online contact form to determine your legal options. All initial inquiries are free of charge and without obligation.

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