FDA warns Novo Nordisk over adverse event reporting failures

The FDA has issued a warning letter to Novo Nordisk over what it called "serious violations" of the rules requiring drugmakers to collect and report side effects after a medicine is on the market. The letter, posted under the date March 5, 2026, cites cases involving patients taking semaglutide (sold as Ozempic and Wegovy) and liraglutide (Victoza and Saxenda) ^[1][3].

The letter went to David S. Moore, president of Novo Nordisk Inc., at the company's U.S. headquarters at 800 Scudders Mill Road in Plainsboro, New Jersey ^[1]. It stems from an FDA inspection of that site conducted between January 13 and February 7, 2025, as part of the agency's Bioresearch Monitoring Program ^[1][2]. Sources differ slightly on timing: the FDA posting is dated March 5, 2026, and Healio reported the letter was sent March 5 ^[3], while the trade publication Regulatory Focus reported it was sent on March 10 ^[2].

What the FDA found

Under federal rules, a company must report any adverse drug experience that is both serious and unexpected to the FDA within 15 calendar days of first learning about it — whether or not anyone thinks the drug caused it ^[1]. The FDA said Novo Nordisk's written procedure, "Handling of Adverse Events and Other Safety Information," allowed reports to be rejected or cancelled if the person reporting said the event was unrelated to the product, a definition the agency called inconsistent with U.S. regulations ^[1].

Specific examples in the letter include:

• Argus Case #1342548, in which a consumer reported the death of a male patient who received semaglutide. Novo Nordisk invalidated the case for lack of a patient identifier; FDA investigators found the identifier in the source documents ^[1][2].
• Argus Case #1171264, in which a non-health care professional reported the death of a patient receiving semaglutide. The case was closed without being reported to FDA because consent was not obtained from the reporter ^[2].
• Argus Case #1079792, in which a physician reported that a patient taking semaglutide was depressed and died by suicide. FDA said the company documented no attempt to get more information, and that as of the letter's date the case had still not been submitted to the agency ^[2].
• A report of suicidal ideation in a patient taking semaglutide that was received December 16, 2024, but not given a medical review until February 3, 2025 — beyond the 10-day window ^[3].
• Argus Case #1331385, involving a consumer disabled after a stroke while taking liraglutide. The company rejected the case because the consumer said the stroke was not drug-related ^[1][2].

Regulatory Focus counted three deaths among semaglutide patients, one by suicide, in the letter, and noted that the agency did not tie the deaths to use of the drug ^[2].

Novo Nordisk had responded to the inspection findings repeatedly — with letters dated March 3, April 11, May 2, June 6, July 11, September 19, and October 31, 2025, and January 15, 2026 ^[1]. Proposed fixes included revising procedures, retrospective case reviews, moving safety intake from contracted call-center agents to in-house health care professionals, and hiring a consultant to review its pharmacovigilance systems back to June 2017 ^[1][3]. The FDA called the responses "inadequate" because the company did not provide enough detail to show the problems were fixed ^[1][2].

Why it matters for patients

The FDA's system for spotting new safety problems depends on drugmakers passing along reports from patients, families and clinicians. As the letter puts it, failure to report and investigate these events "may limit the safety information that FDA may need when monitoring potential safety signals" ^[2]. If reports of deaths, strokes or suicidal thoughts never reach the agency, a possible pattern can take longer to surface.

Importantly, nothing in the letter says these events were caused by semaglutide or liraglutide. FDA did not link the three deaths to the drugs ^[2]. Novo Nordisk said the letter focuses on regulatory compliance and "does not make any conclusions about the quality or safety of our medicines" ^[3]. The letter does not restrict sales, recall any product, or change prescribing information, and no supply disruption is mentioned in the sources.

What happens next

The FDA gave Novo Nordisk 15 business days from receipt to explain what it will do to prevent future violations, with further regulatory action possible if problems continue ^[2][3]. Anna Windle, head of clinical development, medical and regulatory affairs at Novo Nordisk US, said in a March 10 statement that the company plans to address the requests "expeditiously and holistically" and is "confident" it will satisfy the FDA ^[2][3]. Whether the agency accepts the company's next response is not yet known.