On February 13, 2020, the U.S. Food and Drug Administration issued a Drug Safety Communication requesting the manufacturer of weight loss drug Belviq® and Belviq XR® (lorcaserin) withdraw the drug from the U.S. market after a clinical trial showed an increased risk of cancer.
The FDA made its request after finding that Belviq’s potential to increase the risk of certain cancers, including Pancreatic, Colorectal and Lung cancer outweighed the drug’s benefits.
The FDA’s safety communication states “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.”
When the FDA originally approved Belviq in 2012 for chronic weight management in obese adults, it required the manufacturer to undergo a clinical trial on the drug’s cardiovascular risk.
The Belviq clinical trial involved 12,000 patients for a period of over 5 years.
Safety data from the clinical trial showed patients taking Belviq had an increased risk of developing several different types of cancer, including colorectal, pancreatic and lung cancer.
In January 2020 the FDA alerted the public about a possible increased risk of cancer linked to the use of Belviq.
The FDA safety communication recommends patients “stop taking lorcaserin and talk to your health care professionals about alternative weight-loss medicines and weight management programs. stop taking lorcaserin and talk to your health care professionals about alternative weight-loss medicines and weight management programs.”
Belviq manufacturer Eisai Inc. has agreed to withdraw the drug from US markets.