{"id":39029,"date":"2026-03-13T00:49:11","date_gmt":"2026-03-13T00:49:11","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/39029\/"},"modified":"2026-03-13T00:49:11","modified_gmt":"2026-03-13T00:49:11","slug":"feds-warn-ozempic-and-wegovy-maker-over-failure-to-report-side-effects-from-weight-loss-drugs-2","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/39029\/","title":{"rendered":"Feds warn Ozempic and Wegovy maker over failure to report side-effects from weight-loss drugs"},"content":{"rendered":"

Millions of Americans use injectable drugs like Novo Nordisk\u2019s Ozempic and Wegovy<\/a> to help them lose weight<\/a> – knowing there are possible side effects<\/a> such as nausea<\/a>, vomiting and diarrhea.<\/p>\n

Now, the U.S. Food and Drug Administration<\/a> has written a letter<\/a> alleging that the Danish drugmaker failed to report adverse effects in patients who took semaglutide drugs, including death.<\/p>\n

The March 5 letter cited three deaths in unidentified patients, including one patient who died by suicide, and Director of the Office of Scientific Investigations Dr. David Burrow wrote that Novo Nordisk had failed to failed to report \u201cserious and unexpected\u201d adverse drug experiences within the FDA\u2019s required time frame.<\/p>\n

\u201cBased on your written procedure, your staff or contractor cancelled or rejected serious and unexpected adverse drug experiences that were required to be reported within 15 calendar days because they documented these events as being unrelated to the product,\u201d Burrow said.<\/p>\n

However, the FDA stopped short in deciding whether any of the adverse effects were directly linked to the drug.<\/p>\n

\"Ozempic<\/p>\n

Ozempic and Wegovy-maker Novo Nordisk just received a letter from the FDA warning the pharmaceutical giant about its alleged failure to report adverse events (AFP via Getty Images)<\/p>\n

The findings were based on an inspection of a New Jersey facility last year that Burrow said \u201crevealed serious violations\u201d of reporting requirements.<\/p>\n

Since then, Novo Nordisk had taken corrective and preventive actions that officials claimed were \u201cinadequate\u201d because the pharmaceutical giant \u201cdid not provide sufficient details to determine whether [Novo Nordisk\u2019s] actions will effectively prevent similar violations in the future.\u201d<\/p>\n

The company was given 15 business days to address the \u201cdeficiencies\u201d or face \u201cregulatory action.\u201d<\/p>\n

In response to the FDA, Novo Nordisk released a statement<\/a> earlier this week acknowledging the letter and saying it would continue to take steps to address the agency\u2019s observations.<\/p>\n

\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 Novo Nordisk said.<\/p>\n

\"The<\/p>\n

The FDA sent another warning letter to Novo Nordisk after an inspection at the drugmaker\u2019s Bloomington, Indiana, site late last year (AFP via Getty Images)<\/p>\n

The drugmaker said it had received another warning letter after an inspection at a site in Bloomington, Indiana, late last year.<\/p>\n

That inspection was related to the FDA\u2019s Current Good Manufacturing Practice regulations, which ensure that a product is safe and that it has the ingredients and strength it claims to have.<\/p>\n

\u201cWe have full confidence that we will be able to holistically and promptly address the matters outlined in each of the Warning Letters,\u201d said Novo Nordisk.<\/p>\n","protected":false},"excerpt":{"rendered":"Millions of Americans use injectable drugs like Novo Nordisk\u2019s Ozempic and Wegovy to help them lose weight –…\n","protected":false},"author":2,"featured_media":39030,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[271],"tags":[22220,22223,22221,18973,1567,22222,272,21304],"class_list":["post-39029","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novo-nordisk","tag-adverse-effects","tag-adverse-events","tag-david-burrow","tag-drugmaker","tag-food-and-drug-administration","tag-injectable-drugs","tag-novo-nordisk","tag-warning-letter"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@dk\/116219121738054916","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/39029","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=39029"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/39029\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/39030"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=39029"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=39029"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=39029"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}