{"id":282516,"date":"2026-01-13T19:35:07","date_gmt":"2026-01-13T19:35:07","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/282516\/"},"modified":"2026-01-13T19:35:07","modified_gmt":"2026-01-13T19:35:07","slug":"us-fda-requests-removal-of-suicide-warnings-from-weight-loss-drug-labels","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/282516\/","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":282517,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[274],"tags":[82519,2786,82703,82499,36586,82500,82795,82543,82538,82546,82549,82541,96599,82550,82776,83399,84147,87219,82779,82555,82542,82777,82547,82539,82557,82540,82548,82551,110838,83400,96598,18,55396,82578,110839,82520,45748,83117,94682,87209,135,87211,94704,19,61442,17,84108,462,96153,82565,82524,83000,96596,82780,2765,88228,88229,82510,83002,82964,110812,96152,83363,83401,82512,84117,82534,87203,88232,82533,107,82518],"class_list":{"0":"post-282516","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-eire","40":"tag-emea","41":"tag-emrg","42":"tag-endocr","43":"tag-europ","44":"tag-gen","45":"tag-govact","46":"tag-govadm","47":"tag-hea","48":"tag-health","49":"tag-heca","50":"tag-humdis","51":"tag-ie","52":"tag-il","53":"tag-ireland","54":"tag-meast","55":"tag-medication","56":"tag-medreg","57":"tag-mtpix","58":"tag-namer","59":"tag-nord","60":"tag-obesit","61":"tag-packageus-top-news","62":"tag-phar","63":"tag-phar1","64":"tag-phmr","65":"tag-publ","66":"tag-pxp","67":"tag-regs","68":"tag-rhpiapprovals","69":"tag-rhpiregulatory","70":"tag-rsbiregulatory-oversight","71":"tag-scandv","72":"tag-sci","73":"tag-swasia","74":"tag-topcmb","75":"tag-topicpharma-healthcare-business-health","76":"tag-topicpharma-healthcare-policy-regulation","77":"tag-topnws","78":"tag-us","79":"tag-weu"},"share_on_mastodon":{"url":"","error":"Validation failed: Text character limit of 500 exceeded"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/282516","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=282516"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/282516\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/282517"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=282516"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=282516"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=282516"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}