By PPN News Staff

The FDA requested that Eisai, the manufacturer of lorcaserin (Belviq, Belviq XR), voluntarily withdraw the weight loss drug from the U.S. market because of a safety concern.

Lorcaserin was approved in 2012 for use with a reduced-calorie diet and increased physical activity to help weight loss in adults who are obese or overweight and have weight-related medical problems. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and an extended-release tablet (Belviq XR).

When the products were approved, the FDA required Eisai to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk for heart-related problems. In this trial, which was conducted in approximately 12,000 participants over five years, more patients taking lorcaserin were diagnosed with cancer compared with patients taking placebo. 

“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 agency said in a statement. 

The FDA is not recommending special screening for patients who have taken lorcaserin. 

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 patients, the agency said.

The agency said unused lorcaserin should be disposed of using a drug take-back location, but could be thrown in the household trash, if the following steps are taken:

• 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 the household trash.
• Remove or delete all personal information on the prescription label of empty medicine bottles or packaging, and then dispose of or recycle them.