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Regulatory Focus™ > News Articles > 2020 > 1 > FDA Warns of Potential Cancer Risk With Weight Loss Drug

FDA Warns of Potential Cancer Risk With Weight Loss Drug

Posted 14 January 2020 | By Zachary Brennan 

FDA Warns of Potential Cancer Risk With Weight Loss Drug

The US Food and Drug Administration (FDA) on Tuesday alerted the public to the results from a clinical trial that showed a possible increased risk of cancer with Eisai’s weight management drug Belviq (lorcaserin) and the extended release version.

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” FDA said.

First approved in 2012, Belviq is intended to help with weight loss for those eating a reduced-calorie diet and increasing exercise.

The completed randomized, double-blind, placebo-controlled Eisai trial gauged the risk of heart-related problems for approximately 12,000 participants over five years. The trial’s results, published in the New England Journal of Medicine in September 2018, show that the drug met its primary safety objective, finding that long-term treatment did not increase the incidence of major adverse cardiovascular (CV) events in overweight and obese patients at high risk for a CV event.

But FDA said in its safety communication on Tuesday that the trial also found that more patients taking lorcaserin were diagnosed with cancer compared to patients taking placebo. The results also show 215 patients (3.59%) taking locaserin in the trial got cancer, whereas 210 patients (3.50%) taking placebo got cancer.

“Severe hypoglycemia with serious complications (i.e., that required hospitalization, were life-threatening or disabling, or resulted in death) was rare but more common with lorcaserin than with placebo,” the results also note.

FDA Drug Safety Communication

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