{"id":39017,"date":"2026-03-13T00:27:18","date_gmt":"2026-03-13T00:27:18","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/39017\/"},"modified":"2026-03-13T00:27:18","modified_gmt":"2026-03-13T00:27:18","slug":"fda-sends-letter-to-novo-nordisk-over-potential-glp-1-side-effects-2","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/39017\/","title":{"rendered":"FDA sends letter to Novo Nordisk over potential GLP-1 side effects"},"content":{"rendered":"<p>\n\t\t\t\t\t\tThe U.S. Food and Drug Administration sent a warning letter this month to Novo Nordisk, the maker of Ozempic and Wegovy, alleging the drugmaker failed to report potential side effects in patients who took the popular GLP-1 medications in a timely manner.The medications are prescribed for diabetes and weight loss.Related video at the top: What to know about weight-loss scams In the March 5 warning letter, the FDA noted that it observed \u201cserious violations\u201d when a  Post-marketing Adverse Drug Experience inspection was conducted at Novo Nordisk\u2019s New Jersey site early last year.The letter specifically cited three deaths among patients who took semaglutide, which is the generic name for the active ingredient in Ozempic and Wegovy. One of those deaths included a person who died by suicide, according to the letter. It should be noted that the FDA did not say whether the deaths or adverse side effects were specifically caused by the drugs.The pharmaceutical giant didn\u2019t report the deaths to the agency within the FDA\u2019s required timeframe, according to the letter.In a statement released March 10, Novo Nordisk said it initially received inspectional observations from the FDA in February 2025, and that it \u201chas been working diligently to address those observations ever since.\u201dIn the statement on Tuesday, the drugmaker acknowledged it received the warning letter and that it \u201cwelcomes further dialogue with the US FDA.\u201d The company said it is \u201cworking diligently\u201d to address the concerns of the FDA.The drugmaker noted that the FDA\u2019s warning letter acknowledges the \u201csignificant measures Novo Nordisk has taken over the past year meant to ensure full compliance\u201d with reporting requirements. \u201cThe Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines,\u201d the company said.Novo Nordisk said it does not expect the situation to impact production.\n\t\t\t\t\t<\/p>\n<p>The U.S. Food and Drug Administration <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/novo-nordisk-inc-717576-03052026\" target=\"_blank\" rel=\"nofollow noopener\">sent a warning letter this month to Novo Nordisk<\/a>, the maker of Ozempic and Wegovy, alleging the drugmaker failed to report potential side effects in patients who took the popular GLP-1 medications in a timely manner.<\/p>\n<p>The medications are prescribed for diabetes and weight loss.<\/p>\n<p>Related video at the top: What to know about weight-loss scams <\/p>\n<p>In the March 5 warning letter, the FDA noted that it observed \u201cserious violations\u201d when a  Post-marketing Adverse Drug Experience inspection was conducted at Novo Nordisk\u2019s New Jersey site early last year.<\/p>\n<p>The letter specifically cited three deaths among patients who took semaglutide, which is the generic name for the active ingredient in Ozempic and Wegovy. One of those deaths included a person who died by suicide, according to the letter. <\/p>\n<p>It should be noted that the FDA did not say whether the deaths or adverse side effects were specifically caused by the drugs.<\/p>\n<p>The pharmaceutical giant didn\u2019t report the deaths to the agency within the FDA\u2019s required timeframe, according to the letter.<\/p>\n<p>In a <a href=\"https:\/\/www.novonordisk-us.com\/media\/news-archive\/news-details.html?id=916514#\" target=\"_blank\" rel=\"nofollow noopener\">statement released March 10<\/a>, Novo Nordisk said it initially received inspectional observations from the FDA in February 2025, and that it \u201chas been working diligently to address those observations ever since.\u201d<\/p>\n<p>In the statement on Tuesday, the drugmaker acknowledged it received the warning letter and that it \u201cwelcomes further dialogue with the US FDA.\u201d The company said it is \u201cworking diligently\u201d to address the concerns of the FDA.<\/p>\n<p>The drugmaker noted that the FDA\u2019s warning letter acknowledges the \u201csignificant measures Novo Nordisk has taken over the past year meant to ensure full compliance\u201d with reporting requirements. <\/p>\n<p>\u201cThe Warning Letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines,\u201d the company said.<\/p>\n<p>Novo Nordisk said it does not expect the situation to impact production.<\/p>\n","protected":false},"excerpt":{"rendered":"The U.S. Food and Drug Administration sent a warning letter this month to Novo Nordisk, the maker of&hellip;\n","protected":false},"author":2,"featured_media":39018,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[271],"tags":[3954,3336,5401,22184,21032,18973,325,22171,22172,22173,22174,22175,22176,393,22188,428,20435,22190,16562,272,22178,22177,21562,3102,22179,22180,22181,15671,22185,22189,689,22186,22187,22191,1910,21555,22182,22183,280],"class_list":{"0":"post-39017","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-novo-nordisk","8":"tag-company","9":"tag-consumer","10":"tag-death","11":"tag-diabetes-weight-loss-drugs","12":"tag-drug-administration","13":"tag-drugmaker","14":"tag-fda","15":"tag-fda-drug-safety-reporting","16":"tag-fda-drug-violation-notice","17":"tag-fda-post-marketing-inspection","18":"tag-fda-warning-letter-novo-nordisk","19":"tag-glp-1-drugs-safety","20":"tag-glp-1-medications-risk","21":"tag-health","22":"tag-jsnd","23":"tag-law","24":"tag-letter","25":"tag-maker","26":"tag-march","27":"tag-novo-nordisk","28":"tag-novo-nordisk-compliance-fda","29":"tag-novo-nordisk-fda-warning","30":"tag-novo-nordisk-regulatory-issues","31":"tag-ozempic","32":"tag-ozempic-fda-investigation","33":"tag-ozempic-news","34":"tag-ozempic-side-effects","35":"tag-patient","36":"tag-pharmaceutical-safety-reporting","37":"tag-potential-glp-1-side-effect","38":"tag-semaglutide","39":"tag-semaglutide-adverse-reactions","40":"tag-semaglutide-deaths-report","41":"tag-statement","42":"tag-wegovy","43":"tag-wegovy-adverse-events","44":"tag-wegovy-regulation","45":"tag-wegovy-safety-concerns","46":"tag-weight-loss"},"share_on_mastodon":{"url":"","error":"Validation failed: Text character limit of 500 exceeded"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/39017","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/comments?post=39017"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/39017\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/39018"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=39017"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=39017"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=39017"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}