Eisai Pulls Weight Loss Drug Lorcaserin from US Market After Request from FDA


The FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug, according to the FDA.

When FDA approved lorcaserin in 2012, the drug manufacturer was required to conduct a clinical trial to evaluate the risk of cardiovascular problems. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung cancers.

Lorcaserin reduces appetite by activating a type of serotonin receptor known as the 5-HT2C receptor in a region of the brain called the hypothalamus, which is known to control appetite. Receptors have also been found in the choroid plexus, cortex, hippocampus, cerebellum, amygdala, and thalamus regions of the brain.

In January 2020, the FDA announced it was reviewing clinical trial data and alerted the public about a possible cancer risk associated with lorcaserin based on preliminary analysis of the data.

The FDA recommends that patients should stop taking lorcaserin and talk to their health professionals about alternative weight-loss medicines and weight management programs. The FDA recommends it is best to transport unused lorcaserin to a drug take back location for proper disposal.

The FDA reports that people that can’t get to a take back location can dispose of lorcaserin in your household trash using the following method:

Mix the pills with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.

Place the mixture in a container such as a sealed plastic bag.

Throw away the container in your trash at home.

Remove or delete all personal information on the prescription label of empty medicine bottles or packaging, then throw away or recycle them.

FDA is currently not recommending special screening for patients who have taken lorcaserin, and recommends asking your health care professional if you have questions.

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The FDA recommends health professionals stop prescribing and stop dispensing lorcaserin to patients. The FDA also that health care professional inform their patients currently taking lorcaserin, of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine, and discuss alternative weight-loss medicines or strategies with patients.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Shukla AP, Kumar RB, Aronne LJ. Lorcaserin HCL for the treatment of obesity. Expert Opin Pharmacother. 2015;16(16):2531–2538. doi:10.1517/14656566.2015.1096345

FDA | Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication – FDA Requests Withdrawal of Weight-Loss Drug



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