Litigation Starts over Diet Drug Belviq, Yanked from Market Because of Cancer Risk

After being on the market for 8 years, the marginally-effective diet Drug Belviq, made by the Japanese drug company Eisai, has been pulled off the market because it may cause cancer.

Eisai, based in Woodcliff Lake, New Jersey, voluntarily withdrew Belviq from the market in February 13, 2020, at the behest of the U.S. Food and Drug Administration.

Earlier, in January 2020, the FDA had alerted the public about a possible risk of cancer associated with lorcaserin, the active ingredient in Belviq, based on preliminary analysis of the data.

A range of cancer types were reported, including pancreatic, colorectal, and lung. The FDA instructs patients to stop taking the drug.

Litigation underway

Plaintiff law firms are actively marketing to Belviq patients now. Lawsuits against Eisai began to be filed in March 2020, considering it may have a high average case value litigation.

Barbara Zottola of White Plains, NY, filed a class action complaint in March 2020 against Eisai Inc. in U.S. District Court in White Plains, accusing the drug maker of pushing the product to market, despite evidence that it was defective. Zottola is represented by Manhattan attorneys Andrew J. Obergfell and Joseph I. Marchese and Miami attorney Sarah N. Westcot.

The lawsuit also names Arena Pharmaceuticals Inc., the San Diego company that developed and licensed lorcaserin, the active ingredient, and CVS Health Co., the pharmacy chain from which Zottola purportedly bought the drug.

In April 2020, Barbara Zottola of New York filed a class-action lawsuit against Eisai, Inc., claiming it knew about Belviq’s cancer-causing potential for years, yet kept pushing it to market.

The complaint by Saunders & Walker of Pinellas Park, Florida, asks the federal court to certify a class of hundreds of thousands of people across the country who purchased Belviq. The suit seeks damages for alleged breach of an implied warranty, deceptive acts, false advertising, unjust enrichment, fraud, and conversion.

Risk of cancer

Eisai Co., Ltd. is a Japanese pharmaceutical company headquartered in Tokyo, Japan. It has offices in New Jersey, Massachusetts, and Pennsylvania. Eisai, originally a marketing partner on Belviq, acquired the sole rights to the drug from Arena Pharmaceuticals for only $23 million in cash in January 2017.

Belviq revenues for 2017 totaled $21.3 million. The company promoted prescriptions for the weigh-loss drug for $40 with savings cards for commercial-insured patients. Ordinarily, it costs approximately $300 a month and is not covered by most insurance companies.

Belviq was approved by FDA on June 27, 2012, for use with a reduced-calorie diet and increased physical activity to help weight loss in adults who are obese or are overweight and have weight-related medical problems. Belviq is a serotonin 2C receptor antagonist indicated for chronic weight management in adults who are obese, or overweight, and who have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol. It is supposed to work by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and an extended-release tablet (Belviq XR).

A four-year study, requested after Belviq’s approval in 2012, showed a possible link to increased cancer risks in patients with either an established cardiovascular disease or multiple risk factors.

In December 2012, the US Drug Enforcement Administration proposed classifying lorcaserin as a Schedule IV drug because it has hallucinogenic properties at higher than approved doses and users could develop psychiatric dependencies on the drug. On May 7, 2013, the US Drug Enforcement Administration classified lorcaserin as a Schedule IV drug under the Controlled Substances Act.

Interestingly, back on September 16, 2010, an FDA advisory panel had voted 9–5 against approval of the drug based on concerns over both efficacy and safety, particularly the findings of tumors in rats. On October 23, 2010, the FDA at first decided not to approve the drug. This was not only because cancer-promoting properties could not be ruled out, but also because the weight loss efficacy was considered “marginal.”

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