Among the unreported adverse events potentially linked to Ozempic are two deaths and one case of “completed suicide,” according to an FDA inspection report.
Novo Nordisk received a warning letter last week from the FDA for failing to investigate and report adverse events potentially linked to its blockbuster GLP-1 drug Ozempic—including deaths.
“You failed to promptly investigate reports of serious and unexpected events as 15-Day Alert reports instead of periodic individual case reports (ICSRs),” an FDA inspector wrote in a report, adding that Novo did not abide by its own protocol to follow up twice with the reporters of the side effects. Among the safety events that went uninvestigated, according to the regulator, are two deaths—one dated Jan. 30, 2024 and another Dec. 20, 2024—and one suicide. All three were linked to Ozempic.
The FDA inspection took place from Jan. 13, 2025 to Feb. 7, 2025.
The Danish giant likewise failed to file ICSRs—documentation that the FDA requires in the event of a drug toxicity or other product-related problems—for “at least 10” serious and listed events, according to the report. The pharma had also violated mandated timelines for filing adverse events, which typically have to be reported to the FDA within 15 calendar days. Some of Novo’s reports, the inspection report noted, were more than 800 days late.
Novo has also not developed nor deployed written procedures “for the surveillance, receipt and reporting to FDA of post marketing adverse drug experiences,” the report stated. In fact, the inspector continued, “your written procedures inhibit these activities.”
The FDA has discussed the findings of this inspection with Novo, according to the warning letter, which is dated March 5. The pharma has submitted a series of written responses, most recently on Jan. 15, 2026, though the agency still found that Novo did not adhere to statutory requirements and regulations under federal law.
“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 FDA added.
Novo plans “to address the requests in the warning letter expeditiously and holistically,” Anna Windle, the pharma’s head of clinical development, medical and regulatory affairs, said in a statement on Tuesday. “We are confident that we will resolve the matters outlined in the warning letter to the FDA’s full satisfaction.”
The FDA has issued other warnings and communications to Novo recently, including one in September 2025 for deceptive and misleading advertising linked to its semaglutide products, and an inspection report made public in August 2025 flagging violations at a manufacturing plant in Indiana.