Novo Nordisk has received a warning letter from the US Food and Drug Administration (FDA) related to the company’s failure to investigate and flag treatment-emergent adverse events (AEs) associated with its top-selling drug, semaglutide.
According to the letter, an FDA Bioresearch Monitoring Program inspection revealed “serious violations” in Novo’s compliance with post-marketing adverse drug experience (PADE) reporting laws, which require medicine makers to both investigate and inform the FDA of “serious and unexpected” drug-related AEs within 15 calendar days.
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Of the violations, two were patient deaths associated with semaglutide use – one of which was invalidated by Novo due to a failure to capture the patient’s identifier, while the other was not reported to the FDA at all. Semaglutide is the active ingredient in Novo’s blockbuster glucagon-like peptide-1 receptor agonist (GLP-1RA) products, Wegovy and Ozempic.
Other serious events included one case of suicidal ideation and one suicide observed in patients taking semaglutide. While Novo did submit a case late to the FDA for the former incident, the Danish pharma company is yet to report the latter incident, as per the 5 March 2026 letter issued by the FDA.
Novo’s written procedures fall short
The FDA also highlighted Novo Nordisk’s failure to develop written procedures that would allow the company and its contractors to report all serious and unexpected AEs to the agency. This is, in part, because Novo did not follow-up with reporters of adverse events to ask for further information.
The inspection, which the FDA carried out as part of a review into post-marketing adverse drug experience (PADE) compliance between January 13 and February 7, 2025, resulted in a Form FDA 483. The FDA issues documents of this nature after an inspection that outlines improper practice or regulatory shortcomings.
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By GlobalDataSince then, Novo Nordisk has provided several updates to the agency, though the FDA stated that these were “inadequate”. For its part, Novo said that it has been working to resolve the observations through a corrective and preventive action plan that includes seven updates.
On top of the issues associated with semaglutide, the warning letter identified issues around AE reporting for Novo Nordisk’s first-generation GLP-1RA, liraglutide, as the company did not inform the FDA of an event where a patient experienced a disabling stroke while taking the medication. This case was rejected by Novo due to the consumer’s report that the stroke was not related to liraglutide.
In a statement addressing this FDA warning letter, Novo Nordisk’s head of clinical development, Anna Windle noted that the company plans to address the FDA’s warning letter requests “expeditiously and holistically”.
“We are confident that we will resolve the matters outlined in Warning Letter to the FDA’s full satisfaction,” Windle added.
A tumultuous time for Novo Nordisk
This warning letter comes as Novo Nordisk grapples with competition from Eli Lilly in the obesity market, which has seen the company slash 11% of its workforce and forecast a 2026 sales dip amid pricing and patent expiry challenges.
Novo’s chair committee has also had a shakeup in recent months, as the company’s board recently saw a seven-member exodus in October 2025 following a disagreement between the committee and its majority shareholder, the Novo Nordisk Foundation. Since then, the company has flagged members to join the board, which now largely consists of new appointees.
In a bid to turn its fortunes around, Novo’s CEO, Mike Doustdar said the company will reshape its strategy in 2026 – focusing on accelerating commercial execution, expanding cash pay channels in the US, strengthening its R&D pipeline and rolling out its newer product ranges.
