Belviq Pancreatic Cancer Lawsuit Alleges Safety of Diet Drug Misrepresented

A product liability lawsuit filed against Eisai, Inc. and Arena Pharmaceuticals claims that the drug makers misrepresented the safety of their weight-loss drug, and withheld information about the link between Belviq and cancer until federal regulators forced the medication to be removed from the market.

Carla Ortiz filed the complaint (PDF) in the U.S. District Court of the Middle District of Florida on September 9, claiming she developed pancreatic cancer from Belviq, which has left her with severe and permanent injuries, pain, suffering and emotional distress.

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 the drug makers did not disclose 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.

According to the lawsuit, Ortiz, of Florida, began using Belviq in June 2017, and continued to take the drug for weight loss until July 2019. She was diagnosed with pancreatic cancer in September 2017, but was unaware Belviq caused the cancer since the drug makers failed to warn consumers and the medical community about the risk associated with the medication.

“Defendants concealed their knowledge of Belviq’s defects from the Plaintiff Carla Ortiz, her prescribing physician, hospitals, pharmacists, the medical and healthcare community, the FDA, and/or the public in general,” the lawsuit states. “Defendants’ representations and/or omissions were done with the intent of defrauding and deceiving Plaintiff Carla Ortiz, the public in general, and the medical and healthcare community in particular, and were made with the intent of inducing the public in general, and the medical community in particular, to recommend, dispense and/or purchase Belviq for chronic weight management, all of which evinced a callous, reckless, willful, depraved indifference to health, safety, and welfare of the Plaintiff Carla Ortiz.”

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 trial 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 Ortiz 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.