On Jan.14, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication about prescription diet drug Belviq after clinical trial results showed that the drug may be associated with an increased risk of cancer. Now, the FDA has requested that Eisai, Inc. voluntarily withdraw Belviq from the U.S. market. According to the FDA, Eisai, Inc. has already complied and agreed to withdraw the drug from the market.
In 2012, the FDA approved lorcaserin as a type of prescription drug to assist with weight loss in adults. Lorcaserin is available as a tablet (Belviq) and an extended-release tablet (Belviq XR). The medication works by targeting chemical signals that control appetite and allows people to feel fuller after eating smaller amounts of food. Belviq may also be prescribed to obese patients that have other conditions linked to obesity including diabetes, high cholesterol, and high blood pressure. Belviq is manufactured by Eisai, Inc., a U.S. subsidiary of Japan-based pharmaceutical company Eisai Co., Ltd.
When the FDA approved lorcaserin in 2012, it required Eisai, Inc. to conduct a randomized, double-blind, placebo controlled clinical trial to evaluate the risk of heart-related problems. This clinical trial involved approximately 12,000 people over five years. The results showed that more patients taking lorcaserin were diagnosed with cancer compared to patients taking the placebo. This prompted the FDA to alert the public in January 2020. Then, once the FDA continued to evaluate the clinical trial results, it decided to ask Eisai, Inc. to pull Belviq from the market.
In the FDA’s February 2020 statement, it advised that patients “should stop taking lorcaserin (Belviq) and talk to [their] health care professionals about alternative weight-loss medicines and weight management programs.” The FDA also advised physicians to “stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking lorcaserin (Belviq), inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine. Discuss alternative weight-loss medicines or strategies with your patients.”
Lawyers in Beasley Allen’s Mass Torts section are investigating claims of cancer in people who were taking Belviq. For more information, contact Melissa Prickett or Liz Eiland or fill out our contact form.