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Belviq Recalled Following Potential Link To Cancer


The U.S. Food and Drug Administration (FDA) recently called for the manufacturer of Belviq and Belviq XR (lorcaserin) to voluntarily withdraw the weight loss drug from the U.S. Market following results from a randomized clinical trial that shows a possible increased risk of cancer.

Belviq and Belviq XR is a prescription weight loss medication that was approved by the U.S. Food and Drug Administration in June of 2012.  Belviq was indicated for use in individuals with a BMI greater than 27.  Belviq is available as a tablet and an extended release tablet.  The drug works by activating brain receptors for serotonin causing users to experience feelings of fullness to control the user’s appetite.  According to clinical trial data submitted to the FDA, nearly half of the users without Type 2 diabetes lost at least 5% of their starting weight over a year.

Belviq’s FDA approval was contingent upon the manufacturer performing a long term randomized study regarding the cardiovascular safety of the weight loss medication.  The Agency recently completed their analysis of the data from the randomized clinical trial. That analysis prompted the administration to conclude the potential risks of using Belviq outweighed its benefits and the Agency issued a Drug Safety Communication in January of 2020.


The FDA Drug Safety Communication alerted the public that results from the clinical trial showed a possible increased risk of cancer associated with Belviq use.  The FDA stated that a range of cancer types were reported in the group taking lorcaserin, with several types of cancers occurring more frequently which included pancreatic, colorectal and lung cancer.

In February of 2020, the FDA requested that the manufacturer voluntarily withdraw Belviq from U. S. Markets based on their review of the clinical trial results showing that the potential risk of cancer outweighs the benefit of weight loss treatment.  The drug manufacturer, Eisai Inc., submitted a request to voluntarily withdraw the drug.