CV Safety Trial for Lorcaserin Picks Up Cancer Signal: FDA

The US Food and Drug Administration is alerting physicians and the public that a clinical trial designed to assess the cardiovascular safety of the obesity drug lorcaserin (Belviq/Belviq XR; Eisai) is now suggesting a possible increased risk of cancer.

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk,” the agency stated in a MedWatch alert sent Tuesday. “We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed  our review.”

Lorcaserin, a selective agonist of the 5-hydroxytryptamine 2C serotonin receptor, was approved in 2012 as a weight-loss drug to be used in conjunction with calorie restriction and increased physical activity. In 2018, investigators reported results from CAMELLIA-TIMI 61, the postapproval trial mandated by the FDA to make sure the agent had no cardiovascular side effects.

As reported by TCTMD, at a median of 3.3 years of follow-up, major cardiovascular events as a composite, and broken down by heart failure, unstable angina, or coronary revascularization, were not significantly different between lorcaserin- and placebo-treated patients. According to Erin Bohula, MD, DPhil (Brigham and Women’s Hospital, Boston, MA), who presented the trial results at the European Society of Cardiology Congress 2018, no signal of increased cancer or serious neuropsychiatric side effects were seen at that time.

Now, however, a post-hoc analysis of original study database trial suggests an increase in the number of new cancers among lorcaserin-treated patients, prompting the alert today.

The FDA said physicians should weigh the potential risks and benefits when prescribing the drug, urging them to contact the agency if they have concerns about side effects in their patients.