A New York woman filed a class action lawsuit against New Jersey-based Eisai Inc., maker of the diet pill Belviq, alleging the company knew for years that its long-term weight management drug was linked to cancers but pushed for FDA approval anyway. The lawsuit also names Arena Pharmaceuticals Inc., the company that developed and licensed the drug; and CVS Health Co., the pharmacy chain that dispensed the drug to the plaintiff.
Barbara Zottola filed the lawsuit in March 2020 in U.S. District Court in White Plains, one month after the Food and Drug Administration (FDA) ordered the company to remove Belviq from the U.S. market due to long-term studies that showed there was a higher occurrence of cancer in Belviq users compared to people taking a placebo.
“By that point, unfortunately, the damage had already been done,” Zottola’s complaint states.
Belviq contains the active ingredient lorcaserin. In 2010, the FDA rejected Arena’s application to market the drug in the U.S. because studies showed that laboratory rats exposed to lorcaserin developed cancerous tumors. Arena and Eisai later resubmitted the drug application and, in 2012, the FDA agreed to approve the drug for obese adults and overweight adults with at least one other comorbidity such as high blood pressure, high cholesterol, or type 2 diabetes. The approval was contingent upon Eisai conducting a five-year safety study because regulators were concerned about heart risks.
That study was completed in 2018, and shortly thereafter the FDA was alerted to the higher incidence of cancers among Belviq users compared to patients treated with a placebo. The data showed that of the 12,000 study participants, 462 Belviq users were diagnosed with 520 primary cancers including pancreatic cancer, colorectal cancer, and lung cancer; and 423 patients treated with a placebo were diagnosed with 470 cancers. That translates to about one additional case of cancer per 470 Belviq users, the FDA said.
Zottola claims the drug would not have been approved by the FDA if the drug companies had been honest with the agency about its cancer risks. Zottola’s complaint doesn’t state whether she was diagnosed with cancer; however, she wishes the court to certify a class of potentially hundreds of thousands of Belviq users from across the country.
Roger Smith, Ryan Duplechin and Melissa Prickett, attorneys with Beasley Allen Law firm, are currently investigating individual cases of pancreatic cancer, colorectal cancer and lung cancer in patients who have been treated with Belviq.