WASHINGTON — The FDA called for a voluntarily recall of the weight management drug lorcaserin (Belviq, Belviq XR) after data from a postmarketing trial suggested increased cancer risk with the agent.
Manufacturer Eisai will oblige, the agency said on Thursday.
“[O]ur review of the full clinical trial results shows that the potential risk of cancer associated with the drug outweighs the benefit of treatment,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “The company has submitted a request to voluntarily withdraw the drug.”
In its safety communication, FDA said physicians should cease prescribing lorcaserin and contact patients taking the drug to “inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine.”
Woodcock said that no special cancer screening should be recommended to patients on the drug other than standard age and risk-based recommendations.
Data leading to the voluntary recall came from the CAMELLIA-TIMI-61 trial, and follows last month’s safety alert from the FDA of the potential cancer link. Analysis of the study showed a numerically higher cancer incidence over the course of the trial in the lorcaserin arm, at 7.7% versus 7.1% in the placebo arm.
“Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance,” FDA noted.
Just 2 years ago, things were looking up for lorcaserin, as CAMELLIA-TIMI-61 had revealed no excess major adverse cardiovascular event risk, a chief concern with weight-loss agents and the primary focus of the postmarketing study.
Lorcaserin, a serotonin receptor 2C agonist, now joins a rogues’ gallery of FDA-approved weight-loss agents that later had to be taken off the shelves.
In September 1997, the FDA pulled fenfluramine-phentermine, or “Fen-Phen,” from the market, roughly 6 months after its approval due to increased risk of symptomatic valvular heart disease. Then from 1999 to 2012, the agency blocked all weight-loss drugs from gaining approval.
In 2010, sibutramine (Meridia) was also pulled from the market due to an increase in the risk of stroke and MI. But an industry push starting that same year — which included over $60 million in lobbying — helped open the doors for new weight-loss drugs, and for some that had previously been rejected by the FDA. In 2012, lorcaserin became the first FDA-approved drug for weight loss in over a decade.
Last Updated February 13, 2020