Novo Nordisk Receives FDA Warning Letter for Failing to Report Ozempic Safety Signals Including Deaths
The FDA issued a warning letter to Novo Nordisk on March 5, 2026, following an inspection from January 13 to February 7, 2025, at its U.S. headquarters for failing to investigate and report adverse events linked to Ozempic.
Unreported events included two deaths (January 30, 2024, and December 20, 2024) and one completed suicide, plus at least 10 serious events with reports up to 800 days late.
Novo violated protocols by not filing 15-Day Alert reports for serious unexpected events, requiring reporter consent for follow-ups, and lacking proper procedures for post-marketing adverse drug experience (PADE) reporting.
The FDA deemed Novo's responses inadequate, expressing concerns about systemic pharmacovigilance failures across its product portfolio including semaglutide.
Novo Nordisk stated it will address the issues expeditiously and is confident in resolving them to the FDA's satisfaction.