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Regulatory Focus™ > News Articles > 2020 > 2 > Eisai Voluntarily Withdraws Belviq at FDA’s Request

Eisai Voluntarily Withdraws Belviq at FDA’s Request

Posted 13 February 2020 | By Michael Mezher 

Eisai Voluntarily Withdraws Belviq at FDA’s Request

The US Food and Drug Administration (FDA) on Thursday announced it has requested the withdrawal of Eisai’s weight-loss drug Belviq (lorcaserin) and the extended release version Belviq XR after a large postmarketing study found increased rates of pancreatic, colorectal and lung cancer among patients taking the drug.
 
The announcement comes one month after the agency issued a safety communication warning about a possible increased risk of cancer with the drug.
 
Belviq was first approved in 2012 to help with weight loss in patients eating a reduced calorie diet and who are increasing exercise. At the time of approval, FDA required the company to conduct a large randomized, double-blind placebo-controlled trial to evaluate the risk of cardiovascular disease in patients taking the drug.
 
FDA’s analysis of the study found there was an additional case of cancer for every 470 patients taking Belviq for one year.
 
The FDA advises that patients should stop taking Belviq and Belviq XR and speak with their physicians about alternative weight-loss drugs or weight management programs, according to the agency’s website. Despite the potential increased risk of cancer, FDA says it is not recommending any special screening provisions for patients who have taken the drug.
 
In a statement, Eisai says it is complying with FDA’s request and will withdraw both versions of the drug from the US market, though the company says it disagrees with FDA’s assessment of the study.
 
“Eisai’s interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA. The Company’s assessment is that Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated,” Eisai writes.
 
FDA

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