On Feb. 13, 2020, the Food and Drug Administration (FDA) announced it was pulling the weight loss drug Belviq — as well as Belviq XR, an extended release version of the diet pill — off the market because it had been linked to an increased occurrence of cancer. What prompted the FDA to take such drastic measures?
Belviq was originally approved by the FDA in June 2012 as a long-term management tool for weight loss in obese adults and overweight adults with at least one comorbidity such as high blood pressure, high cholesterol, or type 2 diabetes. Belviq contains the active drug ingredient lorcaserin, which helps people lose weight by activating the serotonin 2C receptor in the brain that makes people feel food after eating smaller portions.
This is the same mechanism that was used by the diet pill fenfluramine, the “fen” in the 1990s drug cocktail fen-phen, which was pulled from the market in 1997 after being linked to potentially life-threatening heart valve problems in nearly a third of the patients who were taking the drug.
To ensure the lorcaserin in Belviq wouldn’t cause similar injuries in patients, the FDA agreed to approve it for marketing if the manufacturer, Eisai Inc., agreed to run long-term safety studies to investigate Belviq’s effects on the heart. Those studies, which involved about 12,000 people over a five-year period, ended in June 2018.
But it wasn’t heart issues that raised concerns for researchers. It was the fact that patients treated with Belviq had a higher occurrence of cancers than patients treated with a dummy pill. The cancers most often linked to Belviq include pancreatic cancer, colorectal cancer and lung cancer.
After learning about the results, the FDA on Jan. 14, 2020, issued a Safety Communication alerting consumers of the findings and that it would conduct its own investigation. That led to the agency’s Feb. 13 announcement that it had decided to remove the drug from the U.S. market due to a potential increased risk of cancer.
Roger Smith, Ryan Duplechin and Melissa Prickett, attorneys with Beasley Allen Law firm, are currently investigating cases of pancreatic cancer, colorectal cancer and lung cancer in patients who have been treated with Belviq.