FDA requests withdrawal of weight-loss drug from U.S. market

The manufacturer of lorcaserin will voluntarily withdraw the drug because a safety clinical trial showed that the drug was associated with an increased occurrence of cancer compared to placebo.


With trial results showing an increased occurrence of cancer with the use of lorcaserin (Belviq, Belviq XR), the FDA has requested that the manufacturer withdraw the weight-loss drug from the U.S. market. The manufacturer, Eisai, responded by submitting a request to voluntarily withdraw the drug, the FDA said in a Feb. 13 safety communication.

When lorcaserin was approved in 2012, the FDA required the manufacturer to conduct a trial to evaluate the risk of cardiovascular problems. The trial found that more patients taking lorcaserin (n=462; 7.7%) were diagnosed with cancer compared to those taking placebo (n=423; 7.1%). A range of cancer types were reported, with several (including pancreatic, colorectal, and lung) occurring more frequently in the lorcaserin group.

Clinicians should stop prescribing and dispensing lorcaserin to patients and should discuss alternative weight-loss medicines or strategies, the FDA said. Health care professionals should also contact patients currently taking lorcaserin, inform them of the increased occurrence of cancer seen in the trial, and ask them to stop taking the medicine, the FDA said. Special screening for patients who have taken lorcaserin is not recommended.