FDA warns Novo Nordisk broke safety reporting rules

Federal regulators have warned the maker of Ozempic and Wegovy that it failed to report possible drug side effects to the government.

In a March 5 warning letter, the U.S. Food and Drug Administration (FDA) said Novo Nordisk committed “serious violations” related to safety reporting for semaglutide, the active ingredient in both medications, NBC News reported.

The FDA said the company did not report several serious adverse events, including three deaths among patients taking the drugs, by the legal deadline.

One of the deaths involved a patient who died by suicide, according to the agency. The FDA also said the company failed to investigate or report that case properly.

The agency stressed that the letter does not mean the medications caused the deaths or other side effects.

Instead, the concern involves how quickly the company shared safety information with the agency.

PADE (Postmarketing Adverse Drug Experience) reports are safety reports that drugmakers must send to the FDA after a medicine is approved.

“FDA relies on the complete, accurate and timely submission of PADEs to monitor a product’s safety profile and uphold FDA’s mission to protect and promote public health,” the FDA wrote.

The findings follow an FDA inspection of a Novo Nordisk facility in New Jersey last year.

The agency said the company now has two weeks to explain what steps it will take to prevent violations in the future.

Novo Nordisk said it is already working to fix the issue.

“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” said Anna Windle, head of clinical development, medical and regulatory affairs at the company.

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