Novo Nordisk received a warning letter from the Food and Drug Administration (FDA) on Mar. 5 for failing to investigate and report adverse events potentially linked to its GLP-1 drug Ozempic, including two deaths and one suicide. The FDA inspection took place between Jan. 13 and Feb. 7, 2025.
The issue is significant because timely reporting of serious side effects is required by federal law to ensure patient safety and regulatory oversight of pharmaceuticals.
According to the FDA inspector's report, "You failed to promptly investigate reports of serious and unexpected events as 15-Day Alert reports instead of periodic individual case reports (ICSRs)," adding that Novo did not follow its own protocol for following up with reporters of side effects. The regulator said that among the uninvestigated safety events were two deaths—one on Jan. 30, 2024, another on Dec. 20, 2024—and one suicide, all linked to Ozempic.
The report also stated that Novo Nordisk failed to file ICSRs for at least ten serious adverse events and violated mandated timelines for reporting such incidents, with some reports being more than 800 days late. Additionally, the company had not developed or implemented written procedures for monitoring and reporting post-marketing adverse drug experiences; in fact, "your written procedures inhibit these activities," according to the inspector.
Despite submitting several written responses—the most recent on Jan. 15, 2026—the FDA found Novo's actions insufficient: "Your written response and subsequent correspondence are inadequate because you did not provide sufficient details for the Agency to determine whether your actions effectively resolved the existing issues and will prevent similar violations in the future," the agency wrote.
Anna Windle, head of clinical development, medical and regulatory affairs at Novo Nordisk, said Tuesday that the company plans “to address the requests in the warning letter expeditiously and holistically.” She added: “We are confident that we will resolve the matters outlined in the warning letter to the FDA’s full satisfaction.”
This latest warning follows other recent communications from the FDA to Novo Nordisk—including a September 2025 notice regarding misleading advertising related to semaglutide products and an August 2025 inspection report highlighting violations at a manufacturing plant in Indiana.
