SILVER SPRING, Md. \u2014 The U.S. health regulator asked drugmakers on Tuesday to remove warnings about a potential \u200brisk of suicidal thoughts from widely used GLP-1 weight loss drugs, including Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.<\/p>\n
The request, also covering Novo’s older weight loss drug, Saxenda, \u2060follows a review by the Food and Drug Administration that found no evidence linking GLP-1 receptor agonists to \u200can increased risk of suicidal thoughts or behavior.<\/p>\n
The FDA’s move could ease a key \u2060safety overhang for the fast-growing class of medicines that are being tested or used \u200cfor conditions beyond weight \u200dloss, including cardiovascular issues, fatty liver disease and sleep apnea.<\/p>\n
The warnings, part of \u2060their original approval, were based on reports of \u2060such 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 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 \u200da 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
Novo’s spokesperson said the company is happy to see the FDA’s recommendation to remove the warning from Saxenda and Wegovy’s labels that currently include risks of suicidal ideation and behavior.<\/p>\n
A Lilly spokesperson said the company appreciates “the FDA’s careful consideration of this important safety issue,” adding Lilly will “continue to work \u200cwith the FDA on next steps to ensure that appropriate safety information is available to prescribers.”<\/p>\n
The labels for these drugs \u200cin 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, \u2060irritability or psychosis.<\/p>\n
The review \u200bcovered 91 trials involving 107,910 patients, including 60,338 who \u2060received a GLP-1 drug \u200cand 47,572 who received placebo, it said.<\/p>\n
Contributing:<\/strong> Puyaan Singh<\/p>\n \n The Key Takeaways for this article were generated with the assistance of large language models and reviewed by our editorial team. The article, itself, is solely human-written.\n <\/p>\n","protected":false},"excerpt":{"rendered":"SILVER SPRING, Md. \u2014 The U.S. health regulator asked drugmakers on Tuesday to remove warnings about a potential…\n","protected":false},"author":3,"featured_media":514757,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[64,419,418,210,421,420,1165,425,1060,50,422,423,159,62,399,314,67,132,68,424,313],"class_list":{"0":"post-514756","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-business","9":"tag-cars","10":"tag-classifieds","11":"tag-health","12":"tag-homes","13":"tag-jobs","14":"tag-lifestyle","15":"tag-local","16":"tag-medication","17":"tag-news","18":"tag-radio","19":"tag-salt-lake","20":"tag-science","21":"tag-sports","22":"tag-television","23":"tag-traffic","24":"tag-united-states","25":"tag-unitedstates","26":"tag-us","27":"tag-utah","28":"tag-weather"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115891718483487216","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/514756","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=514756"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/514756\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/514757"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=514756"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=514756"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=514756"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}