A medical trial of the weight-loss drug Belviq (lorcaserin) exhibits an association with an increased danger of most cancers, and the U.S. Food and Drug Administration is requesting that its maker withdraw the drug from the U.S. market.
Eisai Inc. has already “submitted a request to voluntarily withdraw the drug,” Dr. Janet Woodcock, who directs the FDA’s Center for Drug Evaluation and Research, noted in a press release issued Thursday.
Now, “we’re taking steps to notify the public,” she stated, adding that “our review of the full clinical trial results shows that the potential risk of cancer associated with the drug outweighs the benefit of treatment.”
Woodcock stated the FDA is advising that “patients should stop using the medication Belviq and Belviq XR [lorcaserin] and talk to their health care professionals about other treatment options for weight loss. Health care professionals should stop prescribing and dispensing Belviq and Belviq XR.”
The company first introduced that Belviq may need hyperlinks to most cancers in a communication issued Jan 15.
At the time, the FDA stated “we cannot conclude that lorcaserin contributes to the cancer risk,” however “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.”
That assessment seems to have led to requires the voluntary withdrawal of the medicine.
Belviq will increase feelings of fullness so that folks eat less. It’s out there as a tablet (Belviq) and an extended-release pill (Belviq XR).
According to the FDA, Belviq was first accredited in 2012 as an add-on remedy to assist help weight loss, along with weight loss plan and exercise, in individuals who have been overweight or obese.
Contingent on approval, the FDA ordered a randomized, placebo-controlled trial be carried out involving 12,000 individuals tracked for greater than 5 years.
The trial wrapped up in June 2018, and the info showed that whereas 7.1% of those taking a “dummy” placebo developed cancer, that number rose to 7.7% among those taking Belviq.
“A range of cancer types was reported,” the FDA stated. “Several different types of cancers occurred more frequently among patients treated with Belviq, including pancreatic, colorectal and lung cancer. During the trial, one additional cancer per 470 patients treated with the medication for one year was observed.”
People who have already taken Belviq should cease taking it, however “the FDA is not recommending special screening for patients who have taken Belviq,” Woodcock stated.
There’s extra on maintaining a healthy weight at the American Heart Association.