On Aug. 27, 2018, 18 months before the Food and Drug Administration (FDA) called for the withdrawal of the diet pill Belviq, its manufacturer Eisai Inc., rolled out results from a long-term safety study of Belviq. The data found that the drug did not increase the incidence of a major cardiovascular (CV) event in overweight and obese patients at high risk for a heart attack or stroke.
“With this result,” Eisai announced, “Belviq is the first-ever weight loss medication approved for chronic weight management to achieve this objective in a dedicated CV outcomes trial.”
The study results were hailed as “unprecedented,” and cardiologists were hopeful that the obesity treatment would help curb the nation’s obesity epidemic.
But the celebration was short lived. A year and a half later, on Feb. 13, 2020, the FDA called for the removal of Belviq based on the same study. The reason had nothing to do with cardiovascular concerns. The data showed that people using Belviq had a higher rate of cancer compared to patients who were not taking Belviq.
“We are taking this action because we believe that the risks of lorcaserin [Belviq] outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety,” the FDA said in a Safety Communication.
Belviq, which contains the active drug ingredient lorcaserin, was approved by the FDA in June 2012. But because previous weight loss drugs had been pulled from the market for heart risks, the FDA required Eisai to conduct long-term safety studies to determine whether users of Belviq and Belviq XR (and extended release version of the drug) put users at increased risk for heart attacks and strokes.
The study ended in June 2018. While the data showed Belviq users didn’t have more heart attacks or strokes than nonusers, researchers did find that 7.7% of Belviq users were diagnosed with cancer during the study period compared to 7.1% of nonusers. The cancers most often seen in Belviq users were pancreatic, colorectal, and lung cancers. This was substantial enough to prompt the FDA to pull Belviq from the market.
Many people who have used Belviq are understandably concerned. Some who have been diagnosed with cancer may wonder if their cancer could be connected to their use of Belviq.
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.