Esai Co. is removing Belviq and Belviq XR from the market, after a clinical trial suggested the weight loss medications are associated with an increased risk of cancer.
“As noted in a new Drug Safety Communication issued today, patients should stop using the medication Belviq and Belviq XR (lorcaserin) and talk to their health care professionals about other treatment options for weight loss,” Janet Woodcock, director of the U.S. Food & Drug Administration’s (FDA) Center for Drug Evaluation and Research, said in February 13th press release.
Belviq and Belviq XR (lorcaserin) are indicated for use with a low-calorie diet to aid weight loss in obese adults who suffer from weight-related health problems. Belviq received FDA approval in 2012, and Belviq XR (an extended release version of lorcaserin) followed in 2016.
The FDA’s decision to approve Belviq was not without controversy. In fact, the agency initially refused to do so in 2010 because studies involving rats suggested a link to cancer. The FDA eventually concluded the tumors were specific to the animals, clearing the way for Belviq’s 2012 approval. As a condition, however, the drug’s manufacturer was required to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems associated with lorcaserin.
Last month, the FDA reported that the trial – which involved approximately 12,000 participants over 5 years – saw more cases of cancer in the Belviq group compared to the placebo group.
According to yesterday’s Drug Safety Communication, the FDA’s subsequent review showed lorcaserin increased the risk for several cancers, including pancreatic cancer, colorectal cancer, and lung cancer.
The agency is not recommending special cancer screening for patients who have taken Belviq or Belviq XR. But they should stop taking the medications and speak with their doctor about alternative weight-loss drugs and weight management programs.
Health care professionals should stop prescribing Belviq and Belviq XR. They have also been asked to contact any patients taking lorcaserin, inform them of the increased risk of cancer, and request that they stop using the medication.
The FDA has also asked Esai to remove Belviq and Belviq XR from the market. In a statement to CNN, the company disagreed with the agency’s interpretation of the trial data and maintained that lorcaserin has a “positive risk-benefit profile.” Nevertheless, Esai is complying with the FDA’s request.
“Eisai respects the FDA’s decision and is working closely with the Agency on the withdrawal process,” the statement said.