Novo Nordisk Fails Adverse Event Reporting

FDA issued a Warning Letter to Novo Nordisk after an inspection from January 13–February 7, 2025, finding violations of postmarketing adverse drug experience (PADE) reporting requirements under 21 CFR 314.80. The agency cited procedures that allowed rejecting or cancelling serious, unexpected adverse events — including Argus1 case 1331385 involving a stroke on liraglutide — preventing required 15-day reports. The finding obliges Novo Nordisk to correct pharmacovigilance procedures and submit missing reports.