Weight-loss drug to be recalled. FDA says a safety trial showed an increase in cancer
After the FDA said a safety clinical trial revealed “an increased occurrence of cancer,” Eisai agreed to recall weight-loss drugs Belviq and Belviq XR in the United States.
The FDA requested the recall. Acceding to the request doesn’t equal agreement with the request.
“Eisai’s interpretation of the data from the (safety clinical) trial differs from that of the FDA,” part of Eisai’s Thursday statement said. “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.”
Patients taking Belviq (tablet) and Belviq XR (time release tablet), brand name versions of weight-loss drug lorcaserin, are asked to stop taking them and talk to their doctors about other weight-loss methods and medications.
Lorcaserin was approved by the FDA in 2012. Approval required Eisai to do a randomized, double-blind, placebo controlled clinical trial. The test included 12,000 people over five years.
“...More patients taking lorcaserin were diagnosed with cancer compared to patients taking a placebo, which is an inactive treatment,” the FDA said in January before it finished evaluating the trial.
Thursday, evaluation done, the FDA announced, “We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety.”
While the agency said several different kinds of cancers came from the lorcaserin group, it took care to name “pancreatic, colorectal and lung” cancers.
This story was originally published February 13, 2020 at 6:49 PM.
