On February 13, 2020, weight loss drugs Belviq and Belviq XR (lorcaserin) were withdrawn at the FDA’s request after a clinical trial showed an increased incidence of cancer in people who used the drugs.
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FDA requests withdrawal of Belviq after study shows increase in cancer
On February 13, 2020, Eisai Co. withdrew its weight loss drugs Belviq and Belviq XR at the Federal Drug Administration’s request, after a clinical trial showed an increased incidence of cancer in people who used the drugs.
The FDA first alerted the public that results showed a possible increased risk of cancer on January 14, 2020.
In its follow-up February 13 safety communication, the FDA said:
We are taking this action because we believe that the risks of lorcaserin outweigh its benefits.
No new study prompted this withdrawal; instead, it was the FDA’s completed review of data from a clinical trial for lorcaserin that was conducted from 2013 to 2018. This trial was initially focused on evaluating lorcaserin’s risk of cardiovascular problems, rather than cancer.
The FDA explains that for the first few months of the trial, there was “no apparent difference” in the incidence of cancer between the group that took lorcaserin and the group that didn’t; but the longer the trial went on, the more frequently cancer occurred for the lorcaserin group.
While the FDA says a range of cancer types occurred, it identified the most frequent types as:
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