Lawsuit Alleges Recalled Belviq Caused Breast Cancer Diagnosis

A recently filed product liability lawsuit indicates that side effects of the recalled weight loss drug Belviq caused breast cancer to develop in a New York woman, alleging that the drug makers ignored information about the potential cancer risks that users faced and failed to disclose that the drug was never adequately tested or studied.

The complaint (PDF) was filed by Adiaha Campbell in the U.S. District Court for the Southern District of New York on August 12, pursuing damages against Eisai, Inc. and Arena Pharmaceuticals, Inc. as the defendants.

Belviq was approved by the FDA in 2012, as the first new diet pill allowed on the market in the United States in years. Although the medication was introduced after a series of recalls and problems were associated with other weight-loss medications, the lawsuit indicates that the drug makers did not disclose that they failed to properly test or study Belviq for cancer risks, rendering warnings provided with the medication inadequate.

In February 2020, the FDA required a Belviq recall, after identifying an increased incidence of cancer among users of the medication in post-marketing study data.

Campbell indicates she was prescribed Belviq by her doctor and used the weight loss drug from October 2016 through about July 2017. In August 2018, she was diagnosed with breast cancer, which the lawsuit blames on her use of Belviq.

“Prior to applying for and obtaining approval of Belviq, Defendants knew or should have known that human consumption of Belviq was associated with and/or would cause the induction of cancer, and Defendants possessed pre-clinical scientific studies, which Defendants knew or should have known were a signal that Belviq could cause cancer and/or the cancer risk needed further testing and studies prior to its introduction to the market,” the lawsuit states. “From the date Defendants received FDA approval to market Belviq, Defendants made, distributed, marketed, and sold Belviq without adequate warning to Plaintiff’s prescribing healthcare provider or to Plaintiff that Belviq was associated with and/or could cause cancer, presented a risk of cancer in patients who used it, and that Defendants had not adequately conducted complete and proper testing and studies of Belviq with regard to carcinogenicity.”

The decision to allow Belviq on the market was controversial and the consumer watchdog group Public Citizen warned in 2012 that there would likely be problems with Belviq, predicting the diet drug would eventually be removed from the market, like a number of other previously-approved weight-loss treatments.

In July 2019, an expert analysis of clinical trtial data was published by the American College of Cardiology, which looked at the effectiveness and side effects of Belviq, including the largest concern at the time: cardiovascular risks.

While not publicly announced until months later, the data contained concerning indications about a potential link between Belviq and pancreatic cancer, colorectal cancer and lung cancer. However, the FDA did not issue Belviq cancer warnings until January 2020, and several weeks later it was determined the weight loss drug needed to be removed from the market.

The case filed by Campbell joins hundreds of similar complaints filed over the past two years by former users who allege Belviq caused cancers to develop. Since the strongest sales for Belviq came over the last few years the drug was on the market, it is widely expected that additional lawsuits will be filed in the coming months and years, as former users may be diagnosed with cases of breast cancer, pancreatic cancer, colorectal cancer, lung cancer and other injuries.