Novo Nordisk Failed to Report Ozempic-Linked Deaths and Suicide, FDA Warns

The U.S. Food and Drug Administration issued a warning letter to Novo Nordisk on March 5 over failures to report adverse events potentially linked to semaglutide — the active ingredient in Ozempic and Wegovy — including two deaths and a suicide, according to reporting and the agency’s letter.

“Among the unreported adverse events potentially linked to Ozempic are two deaths and one case of “completed suicide,” according to an FDA inspection report”

BioSpace

Forbes summarised the topline finding, noting the warning related specifically to semaglutide and the March 5 letter, while Mint cited the agency’s report that the cases involved two deaths and one suicide and BioSpace echoed the FDA inspection conclusion that unreported events included two deaths and a “completed suicide.”

BioSpace

The FDA inspection and reporting review flagged both specific reporting lapses and systemic process problems.

Mint reported that an April 2024 internal discovery at Novo found failures to properly report serious adverse events dating back to 2020 and that a 2025 FDA inspection uncovered over 300 unsubmitted reports, with some delayed by more than 1,000 days; BioSpace quoted an FDA inspector saying Novo “failed to promptly investigate reports of serious and unexpected events as 15-Day Alert reports instead of periodic individual case reports (ICSRs)” and added that the company did not follow its own follow-up protocol.

Forbes

Forbes also framed the issue as failures to report side effects potentially linked to Ozempic, underscoring the regulator’s action.

Novo Nordisk has disputed neither the existence of the warning nor that the events were reviewed, and has told reporters it has taken steps to process and report the cases while engaging with the FDA.

“Danish drugmaker Novo Nordisk is now in focus and is facing scrutiny from the US Food and Drug Administration (FDA)”

Mint

Forbes quoted Novo saying the cases “have been evaluated, and Novo Nordisk has ensured they are processed and reported appropriately,” and that the company has submitted “an initial response and seven updates” to the agency; Mint noted Novo’s public pledge to address FDA concerns “expeditiously and holistically” and said the company has been working with the agency on an action plan since the 2025 inspection.

BioSpace’s coverage likewise documented the company’s receipt of the warning and the inspector’s findings.

The warning letter has landed as Novo’s market position and investor sentiment face pressure, and regulators say outstanding compliance gaps remain.

Forbes pointed to significant stock declines this year amid regulatory scrutiny and competition from Eli Lilly, while Mint put the recent Copenhagen drop at about 3.3% and noted a nearly 22% slide since January as investors flagged market-position concerns.

BioSpace

The FDA, according to Mint, also said Novo has not yet demonstrated how planned changes will prevent future violations and flagged company procedures — such as a policy that could withhold potential adverse events when reporters deemed them unrelated — as noncompliant; BioSpace’s coverage of the inspector’s criticisms reinforces the regulator’s procedural concerns.

Importantly, the agency did not say the deaths were definitively caused by Ozempic, a point Mint explicitly noted.