The manufacturers of Belviq are facing a new lawsuit over the medication’s alleged link to cancer.
The complaint, which was filed on March 27th in the U.S. District Court, Southern District of New York, seeks class action status on behalf of thousands of consumers throughout the United States who purchased Belviq following its approval by the U.S. Food & Drug Administration in 2012. (Case No. 7:20-cv-02600)
Belviq (locaserin) is prescribed in combination with diet to aid weight loss in obese adults who suffer from weight-related health problems. While it’s not clear how the medication works, it’s believed Belviq activates the brain’s serotonin receptors to produce feelings of fullness and satisfaction.
As the Belviq lawsuit points out, the drug’s FDA approval was delayed by two years because of animal studies that suggested locaserin might increase the risk for cancer, as well as concerns that patients who used the medication might be vulnerable to heart valve problems. Eventually, however, the FDA was convinced that the tumors observed in those studies were specific to the animals. Data provided by the manufacturer also suggested the heart valve issues would not occur at the low doses at which Belviq was prescribed.
When the FDA approved Belviq in 2012, it also ordered a post-marketing study to assess any possible association between locaserin and an increased risk of heart attack, stroke, or other serious cardiovascular problems. That study was completed in 2018 and suggested Belviq was safe for the heart.
Earlier this year, however, the FDA warned that further review of the trial data had revealed more cases of cancer among Belviq users compared to participants taking a placebo. The agency subsequently ordered a Belviq recall and directed doctors to stop prescribing the medication.
According to the FDA’s most recent Drug Safety Communication, 7.7% of those in the Belviq group were diagnosed with cancer, versus just 7.1% in the placebo group. While a range of cancers were observed, pancreatic, colorectal. and lung cancers were reported more often in the patients who took Belviq.
The newly filed Belviq lawsuit alleges that, from the early stages of development, the drug’s manufacturers knew that locaserin could substantially increase the likelihood for cancer, but continued to market Belviq and Belviq XR as safe and effective for weight loss. The complaint further asserts that consumers would have not taken locaserin had they known about the cancer risk.
“The substantial increase in the risk of cancer when using the medication was not counterbalanced by efficacy. First, the medications are intended for weight loss, medication, and are not a life-saving medication,” the complaint states. “Not only that, but the Belviq Medications were not particularly effective anyway, achieving only about a 5% weight loss for individuals who were already obese.”