THURSDAY, February 13, 2020 (HealthDay News) – A clinical trial of Belviq weight loss medication (lorcaserin) shows an association with an increased risk of cancer, and the U.S. Food and Drug Administration requests that its manufacturer Remove the drug from the US market.
Eisai Inc. has already "submitted a request to voluntarily withdraw the medication," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research, in a statement issued Thursday.
Now, "we are taking steps to notify the public," he said, adding that "our review of the full results of clinical trials shows that the potential cancer risk associated with the drug outweighs the benefit of the treatment."
Woodcock said the FDA advises that "patients should stop using the drug Belviq and Belviq XR (lorcaserin) and talk with their health professionals about other treatment options for weight loss. Health professionals should stop prescribe and dispense Belviq and Belviq XR ".
The agency first announced that Belviq could have links to cancer in a communication issued on January 15.
At that time, the FDA said that "we cannot conclude that lorcaserin contributes to cancer risk," but "I wanted to inform the public about this potential risk. We will continue to evaluate the results of clinical trials and communicate our conclusions and final recommendations when we have completed our review. "
That review seems to have led to calls for voluntary withdrawal of medication.
Belviq increases feelings of fullness so that people eat less. It is available as a tablet (Belviq) and extended-release tablet (Belviq XR).
According to the FDA, Belviq was first approved in 2012 as a complementary therapy to help with weight loss, along with diet and exercise, in obese or overweight people.
Depending on the approval, the FDA ordered a randomized, placebo-controlled trial involving 12,000 people screened for more than five years.
The trial concluded in June 2018, and the data showed that, while 7.1% of those who took a "fake" placebo developed cancer, that number increased to 7.7% among those who took Belviq.
"A variety of cancers were reported," the FDA said. "Several different types of cancers occurred more frequently among patients treated with Belviq, including pancreatic, colorectal and lung cancer. During the trial, an additional cancer was observed for every 470 patients treated with the drug for one year."
People who already took Belviq should stop taking it, but "the FDA does not recommend a special evaluation for patients who took Belviq," Woodcock said.
. (tagsToTranslate) Belviq (t) diet medication (t) FDA (t) withdraw (t) cancer risk (t) lorcaserin (t) clinical trial