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FRIDAY, Feb. 14, 2020 — A medical trial of the weight-loss drug Belviq (lorcaserin) reveals an affiliation with an elevated threat for most cancers, and the U.S. Meals 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,” Janet Woodcock, M.D., who directs the FDA Heart for Drug Analysis and Analysis, famous in an announcement issued Thursday. Now, “we’re taking steps to inform the general public,” she mentioned, including that “our evaluate of the total medical trial outcomes reveals that the potential threat of most cancers related to the drug outweighs the advantage of remedy.”

Woodcock mentioned the FDA is advising that “sufferers ought to cease utilizing the treatment Belviq and Belviq XR and discuss to their well being care professionals about different remedy choices for weight reduction. Well being care professionals ought to cease prescribing and dishing out Belviq and Belviq XR.”

In keeping with the FDA, Belviq was first accredited in 2012 as an add-on remedy to assist help weight reduction, together with food regimen and train, in individuals who had been overweight or chubby. 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 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.

Individuals who have already taken Belviq ought to cease taking it, however “the FDA shouldn’t be recommending particular screening for sufferers who’ve taken Belviq,” Woodcock mentioned.


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Posted: February 2020