THURSDAY, Feb. 13, 2020 (HealthDay News) — A clinical trial of the weight-loss drug Belviq (lorcaserin) exhibits an affiliation with an elevated danger of cancer, 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, famous in an announcement issued Thursday.
Now, “we’re taking steps to notify the public,” she stated, including 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 “sufferers ought to cease utilizing the medication Belviq and Belviq XR [lorcaserin] and discuss to their well being care professionals about different remedy choices for weight loss. Health care professionals ought to cease prescribing and shelling out Belviq and Belviq XR.”
The company first introduced that Belviq might 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 review seems to have led to requires the voluntary withdrawal of the remedy.
Belviq will increase emotions of fullness so that individuals eat much less. It’s accessible as a pill (Belviq) and an extended-release pill (Belviq XR).
Contingent on approval, the FDA ordered a randomized, placebo-controlled trial be carried out involving 12,000 folks tracked for more than 5 years.
The trial wrapped up in June 2018, and the information confirmed that whereas 7.1% of these taking a “dummy” placebo developed most cancers, that quantity rose to 7.7% amongst these taking Belviq.
“A range of cancer types was reported,” the FDA stated. “Several various kinds of cancers occurred more regularly amongst sufferers handled with Belviq, together with pancreatic, colorectal and lung cancer. During the trial, one extra most cancers per 470 sufferers handled with the remedy for one 12 months was noticed.”
People who’ve already taken Belviq ought to cease taking it, however “the FDA is not recommending special screening for patients who have taken Belviq,” Woodcock stated.