{"id":693846,"date":"2026-01-13T20:15:09","date_gmt":"2026-01-13T20:15:09","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/693846\/"},"modified":"2026-01-13T20:15:09","modified_gmt":"2026-01-13T20:15:09","slug":"us-fda-requests-removal-of-suicide-warnings-from-weight-loss-drug-labels","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/693846\/","title":{"rendered":"US FDA requests removal of suicide warnings from weight-loss drug labels"},"content":{"rendered":"

Jan 13 (Reuters) – The U.S. health regulator asked drugmakers on Tuesday to remove label warnings about a potential risk of suicidal thoughts from widely used GLP-1 weight-loss drugs, including Novo Nordisk’s (NOVOb.CO), opens new tab<\/a> Wegovy and Eli Lilly’s (LLY.N), opens new tab<\/a> Zepbound.<\/p>\n

The request, also covering Novo’s older weight-loss drug, Saxenda, follows a review by the U.S. Food and Drug Administration that found no evidence linking GLP-1 receptor agonists to an increased risk of suicidal thoughts or behavior.<\/p>\n

Sign up here.<\/a><\/p>\n

The FDA’s move could ease a key safety overhang for the fast-growing class of medicines that are being tested<\/a> or used for conditions beyond weight loss, including cardiovascular issues, fatty liver disease<\/a> and sleep apnea.<\/p>\n

The warnings, part of their original approval, were based on reports of such events observed with a variety of older medicines used or studied for weight loss, the FDA said.<\/p>\n

A Reuters review of the agency’s adverse-event database in 2023 had found that it received 265 reports<\/a> of suicidal thoughts or behavior in patients taking these or similar medicines since 2010.<\/p>\n

GLP-1 receptor agonists, originally developed to treat type 2 diabetes, mimic a gut hormone that suppresses appetite, creating a feeling of fullness.<\/p>\n

Novo’s Saxenda contains liraglutide and Wegovy contains semaglutide as their respective active ingredients, while Lilly’s Zepbound contains tirzepatide.<\/p>\n

While the FDA, in a preliminary review<\/a>, as well as the European Union’s<\/a> drug regulator, had reached a similar conclusion in 2024, the FDA had said at the time that it could not rule out a small risk because of limited data.<\/p>\n

The labels for these drugs in the EU do not carry such warnings.<\/p>\n

The regulator said on Tuesday it had conducted further analyses of placebo-controlled clinical trials involving GLP-1 drugs, which did not show an increased risk of suicidal thoughts or behavior versus the placebo, nor other psychiatric side effects such as anxiety, depression, irritability or psychosis.<\/p>\n

The review covered 91 trials involving 107,910 patients, including 60,338 who received a GLP-1 drug and 47,572 who received placebo, it said.<\/p>\n

Reporting by Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar and Alan Barona<\/p>\n

Our Standards: The Thomson Reuters Trust Principles., opens new tab<\/a><\/p>\n

Purchase Licensing Rights<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Jan 13 (Reuters) – The U.S. health regulator asked drugmakers on Tuesday to remove label warnings about a…\n","protected":false},"author":2,"featured_media":693847,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4315],"tags":[124884,521,124888,84731,36313,84737,201796,168726,168721,168727,168730,168724,206946,168731,201809,202036,168736,168720,168735,168733,168725,201810,168728,168722,168734,168723,168729,168732,209460,159559,206945,12920,124890,209461,84751,124880,203122,209466,168711,105,168712,209462,16662,202029,4326,168740,202119,124887,127513,209463,168737,168715,203294,168716,168719,202044,168741,209464,168739,168709,202560,54750,202559,84744,209465,168738,84729,16,15,978,84750],"class_list":{"0":"post-693846","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-amers","9":"tag-asia","10":"tag-asxpac","11":"tag-bact","12":"tag-biz","13":"tag-cmpny","14":"tag-cprod","15":"tag-destabn","16":"tag-destabx","17":"tag-destbnx","18":"tag-destdnp","19":"tag-deste","20":"tag-destef-business-future-of-health","21":"tag-destfun","22":"tag-destg","23":"tag-destocatpm","24":"tag-destousdnm","25":"tag-destoushem","26":"tag-destoustpm","27":"tag-destpco","28":"tag-destpcu","29":"tag-destpge","30":"tag-destpsc","31":"tag-destrast","32":"tag-destrbn","33":"tag-destrnp","34":"tag-destu","35":"tag-destucdptest","36":"tag-diabet","37":"tag-dk","38":"tag-efbusiness-future-of-health","39":"tag-emea","40":"tag-emrg","41":"tag-endocr","42":"tag-europ","43":"tag-gen","44":"tag-govact","45":"tag-govadm","46":"tag-hea","47":"tag-health","48":"tag-heca","49":"tag-humdis","50":"tag-il","51":"tag-meast","52":"tag-medication","53":"tag-medreg","54":"tag-mtpix","55":"tag-namer","56":"tag-nord","57":"tag-obesit","58":"tag-packageus-top-news","59":"tag-phar","60":"tag-phar1","61":"tag-phmr","62":"tag-publ","63":"tag-pxp","64":"tag-regs","65":"tag-rhpiapprovals","66":"tag-rhpiregulatory","67":"tag-rsbiregulatory-oversight","68":"tag-scandv","69":"tag-sci","70":"tag-swasia","71":"tag-topcmb","72":"tag-topicpharma-healthcare-business-health","73":"tag-topicpharma-healthcare-policy-regulation","74":"tag-topnws","75":"tag-uk","76":"tag-united-kingdom","77":"tag-us","78":"tag-weu"},"share_on_mastodon":{"url":"","error":"Validation failed: Text character limit of 500 exceeded"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/693846","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=693846"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/693846\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/693847"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=693846"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=693846"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=693846"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}