Florida Woman Blames Belviq for Her Breast Cancer

A Florida woman and her husband recently filed a new Belviq lawsuit in the United States District Court for the Middle District of Florida. The plaintiff claims that after taking the weight-loss drug Belviq, she suffered from serious injuries. She seeks compensatory and punitive damages.

Plaintiff Used Belviq for Years, then was diagnosed with Breast Cancer

According to her complaint, the plaintiff first started using Belviq in August 2013 and continued to use it through early 2020. Her primary care physician and his colleague both prescribed the drug to her.

Subsequently, on November 24, 2917, the plaintiff was diagnosed with breast cancer. As a result, she suffered from severe and permanent personal injuries, pain, suffering, and emotional distress. She blames her diagnosis and consequent injuries on Belviq, which is produced and manufactured by Eisai, Inc., a Delaware corporation with a principal place of business in Woodcliff Lake, New Jersey.

Early Animal Studies Suggested Belviq Linked to Cancer

Belviq was first developed by Arena Pharmaceuticals, which received FDA approval to market the drug on June 27, 2012. It is meant to be used in unison with a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with a body mass index (BMI) greater than or equal to 30, or adult patients with a BMI greater than or equal to 27 and at least one weight-related comorbid condition.

Arena and Eisai jointly launched Belviq in the United States, promoting its safety and efficacy in press releases, through in-person presentations at conferences, in the drug label, in print materials, through websites associated with Belviq, and in other public outlets. On July 15, 2016, the FDA approved an extended-release version of the drug.

During the preclinical trial program for Belviq, however, animal studies revealed that it induced multiple cancerous tumors, including an increase in mammary tumors. The manufacturers claim this is a rodent-specific phenomenon that would not affect humans.

In 2017, Eisai purchased the global rights from Arena to develop and market Belviq.

Post-Marketing Trial on Belviq Reveals Potential Cancer Risk

Though the FDA approved Belviq despite the concerns about cancer, the European Medicines Agency (EMA) did not. In reviewing the data, the EMA Committee for Medicinal Products for Human Use (CHMP) determined that Belviq was not approvable because of concerns about its efficacy and carcinogenicity.

The FDA did, however, set a condition upon its initial approval in 2012. It required the manufacturers to conduct a clinical trial to evaluate the risk of heart-related problems. Eisia tested the product in 12,000 people who were overweight or obese. The patients had either established cardiovascular disease or were at least 50 years old for men and 55 years for women with type 2 diabetes plus at least one additional cardiovascular risk factor.

The participants took either lorcaserin (Belviq) 10 mg twice daily or a placebo. The results showed no major difference in cardiovascular events like heart attack and stroke. However, there was a difference in the number of patients who were diagnosed with cancer.

During the course of the trial, 462 (7.7 percent) of the patients treated with Belviq (lorcaserin) were diagnosed with cancer—including pancreatic, colorectal, and lung cancer—versus 423 (7.1 percent) of the patients taking the placebo. The longer the patients took the drug, the more of an imbalance there was, indicating that the risk may increase with longer-term use.

On February 13, 2020, the FDA announced that it was requesting the manufacturer of Belviq and Belviq XR to voluntarily withdraw the weight-loss drug from the market “because a safety clinical trial shows an increased occurrence of cancer.” The agency further stated it believed the risks of lorcaserin outweighed its benefits based on its completed review of the trial results.