{"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":"","_share_on_mastodon":"0"},"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":["post-282516","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-amers","tag-asia","tag-asxpac","tag-bact","tag-biz","tag-cmpny","tag-cprod","tag-destabn","tag-destabx","tag-destbnx","tag-destdnp","tag-deste","tag-destef-business-future-of-health","tag-destfun","tag-destg","tag-destocatpm","tag-destousdnm","tag-destoushem","tag-destoustpm","tag-destpco","tag-destpcu","tag-destpge","tag-destpsc","tag-destrast","tag-destrbn","tag-destrnp","tag-destu","tag-destucdptest","tag-diabet","tag-dk","tag-efbusiness-future-of-health","tag-eire","tag-emea","tag-emrg","tag-endocr","tag-europ","tag-gen","tag-govact","tag-govadm","tag-hea","tag-health","tag-heca","tag-humdis","tag-ie","tag-il","tag-ireland","tag-meast","tag-medication","tag-medreg","tag-mtpix","tag-namer","tag-nord","tag-obesit","tag-packageus-top-news","tag-phar","tag-phar1","tag-phmr","tag-publ","tag-pxp","tag-regs","tag-rhpiapprovals","tag-rhpiregulatory","tag-rsbiregulatory-oversight","tag-scandv","tag-sci","tag-swasia","tag-topcmb","tag-topicpharma-healthcare-business-health","tag-topicpharma-healthcare-policy-regulation","tag-topnws","tag-us","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}]}}