FDA warns Novo Nordisk over unreported deaths in semaglutide patients

The FDA has told Novo Nordisk Inc. that its system for tracking and reporting side effects after a drug reaches the market violated federal rules, citing cases in which serious events — including three deaths in patients taking semaglutide, one of them by suicide — were never sent to the agency on schedule. The FDA did not link any of the deaths to the drug ^[1][2].

The letter is dated March 5, 2026, and addressed to David S. Moore, president of Novo Nordisk Inc. at 800 Scudders Mill Road in Plainsboro, New Jersey ^[1]. The timing is described differently in two industry publications: RAPS wrote that the agency sent it March 10, 2026, while Healio reported March 5 ^[2][3]. The document appears on the FDA site under reference number 26-HFD-45-03-01 ^[1].

What the inspection found

FDA investigators were at the Plainsboro headquarters from Jan. 13 to Feb. 7, 2025, as part of the agency's Bioresearch Monitoring Program, and reviewed the company's compliance with postmarketing adverse drug experience (PADE) requirements in section 505(k) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.80. The agency called the violations serious ^[1].

The letter's central criticism concerns a written procedure, Q014048, "Handling of Adverse Events and Other Safety Information" (version 28.0, effective Oct. 3, 2024), which allowed reports to be canceled or rejected when the person filing them said the event was unrelated to the product. Federal rules define an adverse drug experience as any adverse event connected to a drug's use "whether or not considered drug-related," and require serious, unexpected events to reach the FDA within 15 calendar days, according to the letter ^[1].

Specific cases described in the warning letter:

• Argus Case #1342548: a consumer reported the death of a male patient who received semaglutide. Novo Nordisk invalidated the case for a missing patient identifier; FDA said it located that identifier in the case's source documents ^[1][2].
• Argus Case #1171264: a person who was not a health care professional reported the death of a semaglutide patient. The company did not obtain consent from the reporter and closed the case without sending it to the FDA ^[1][2].
• Argus Case #1079792: a physician told a company representative that a patient on semaglutide was depressed and committed suicide. The letter says no attempt to gather more information was documented, and the case had not been submitted when the letter was issued ^[1][2].
• Argus Case #1331385: a consumer was disabled by a stroke while taking liraglutide, sold as Victoza and Saxenda. The reporter said the stroke was not related to the drug, and the company rejected the case. The FDA said it was a serious and unexpected event that should have been reported ^[1][2][3].

Healio reported an additional finding: the company received a report of suicidal ideation in a semaglutide patient on Dec. 16, 2024, but did not complete a medical review until Feb. 3, 2025 ^[3].

Company response and FDA reply

Novo Nordisk opened a deviation, DV0166369, in April 2024 after finding that some reportable cases had not gone to the FDA. The root-cause analysis concluded that the procedure matched rules used by foreign regulators but not US ones. The deviation was closed in December 2024, yet the letter says the current procedure still contained causality language, and the company did not supply case numbers and submission dates for all the reports it says it later filed, leaving the FDA unable to verify them ^[1].

Corrective steps described by the company include revised procedures, retrospective reviews of closed cases, shifting safety case intake from contracted call-center agents to in-house patient safety agents who are health care professionals, and creating vendor management, vendor quality and training teams ^[1]. The FDA called these responses inadequate, saying they lack detail on how future compliance will be ensured ^[1][3].

"Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically," Anna Windle, head of clinical development, medical and regulatory affairs at Novo Nordisk US, said in a statement dated March 10 ^[2][3]. The company also said the letter "does not make any conclusions about the quality or safety of our medicines" ^[3].

Why it matters for patients

Nothing in the letter concludes that semaglutide or liraglutide caused the deaths and injuries it describes; the agency did not tie the deaths to the drug ^[2]. The government's concern is the flow of information. "FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product's safety profile," the letter states, adding that missing or late reports may limit the safety data available when the agency evaluates a potential signal ^[2]. In practical terms, a thinner reporting record means regulators, researchers and doctors have less evidence to work with when questions arise about a drug. Novo Nordisk said the letter addresses regulatory compliance rather than the safety or quality of its medicines ^[3]. Whether the FDA will require any labeling change for these products as a result has not been reported.

What happens next

Novo Nordisk has 15 business days from receipt of the letter to tell the FDA how it will prevent similar violations, and the agency said further regulatory action is possible if problems continue ^[2][3]. The company said it is confident it will resolve the matters to the FDA's full satisfaction ^[2][3]. No date for the company's formal reply, and no schedule for any follow-up FDA action, has been disclosed.