FDA Asks Manufacturer to Withdraw Diet Drug Over Cancer Risk

The FDA issued a safety communication asking Eisai Co. to voluntarily recall its weight management drug lorcaserin, a selective activator of 5-HT2C serotonin receptors in the hypothalamus, following a review of post-marketing trial data that suggested an increased cancer risk with the agent.

“Our review of the full clinical trial results shows that the potential risk of cancer associated with the drug outweighs the benefit of treatment,” said Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, in a statement. “Patients should stop using [lorcaserin] and talk to their health-care professionals about other treatment options for weight loss.”

The agency also asked health-care professionals to stop prescribing and dispensing lorcaserin but did not recommend special cancer screening for patients taking the drug.

Lorcaserin was approved in 2012 as an adjunct therapy to a reduced-calorie diet and increased physical activity for chronic weight management among adults who were obese or overweight with at least one weight-related comorbidity. In its review of safety data from the required post-market clinical trial, the FDA found that more patients taking the medication were diagnosed with cancer (n=462; 7.7%) than those taking a placebo (n=423; 7.1%). Several different types of cancers occurred more frequently among patients treated with lorcaserin, including pancreatic, colorectal, and lung cancer, the FDA reported. The molecular mechanism by which lorcaserin increased the risk of malignancy in the post-marketing trial is unclear.

Source: FDA news release, February 13, 2020.