Health Care FDA sends warning letter to Novo Nordisk over failure to report deaths, adverse side effects of GLP-1s by Sophie Brams - 03/10/26 6:21 PM ET by Sophie Brams - 03/10/26 6:21 PM ET Share ✕ LinkedIn LinkedIn Email Email NOW PLAYING The U.S. Food and Drug Administration (FDA) has issued a warning to Novo Nordisk over its alleged failure to report adverse side effects, including death, in patients who took its GLP-1 medications , popularly known as Ozempic and Wegovy. The FDA wrote in a March 5 letter that it observed “serious violations” of reporting requirements during an inspection at a Novo facility in early 2025.   The letter cited three deaths among patients using semaglutide , the active ingredient in several of its weight-loss medications, which it said were not properly investigated or reported. One of those cases involved suicide, according to the FDA. The agency accused Novo of violating procedures that required the company to perform follow-ups in cases where death occurred. The FDA also said the company failed to report adverse reactions to the medication within the required 15-day timeframe. The FDA highlighted one case in which a patient was disabled after suffering a stroke while receiving liraglutide, another GLP-1.   “The consumer reported the stroke was not related to liraglutide, therefore you rejected this case. As a result, you failed to report serious and unexpected [adverse drug events] to FDA within 15 calendar days as required by [Postmarketing Adverse Drug Experience] regulations,” the letter stated. The FDA did not conclude whether any reported adverse effects, including death, were explicitly linked to use of the drugs. Novo said in a statement on Tuesday that the company implemented a “corrective and preventative action plan” following the inspection to resolve the FDA’s concerns. “Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” said Anna Windle, the head of Clinical Development, Medical and Regulatory Affairs. “We are confident that we will resolve the matters outlined in Warning Letter to the FDA’s full satisfaction.” While the FDA acknowledged those steps in its letter, the agency dismissed the company’s initial response as “inadequate” because it did not provide “sufficient details” on how to prevent similar violations in the future. The agency gave the drug company 15 days to outline the additional measures it will take or potentially face regulatory action. Add as preferred source on Google Tags Copyright 2026 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed. Share ✕ LinkedIn LinkedIn Email Email More Health Care News See All Health Care Alleged overpayments to Medicare Advantage plans cost seniors billions: Investigation by Joseph Choi 2 hours ago Health Care  /  2 hours ago