FDA warns Novo Nordisk of potential unreported GLP-1 side effects

The Food and Drug Administration has sent a warning letter to Novo Nordisk — the maker of Ozempic and Wegovy — for failing to report potential side effects in patients taking its blockbuster drugs.

In a letter dated March 5, the FDA criticized Novo Nordisk for “serious violations” related to reporting possible side effects related to semaglutide, the active ingredient in Ozempic and Wegovy.

The FDA cited three deaths among patients who took the drugs, including one patient who died by suicide, saying the company failed to report them within the agency’s required time frame. In the suicide case, the agency said the company did not investigate or report the case.

The agency did not say whether the drugs caused the deaths or other side effects.

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

The agency said the findings were based on a 2025 inspection of a Novo Nordisk facility in New Jersey.

The agency says it is giving the drugmaker two weeks to inform it of steps it will take to prevent future violations.

In a statement posted online, Novo Nordisk said the company was working “diligently” to address the FDA’s concerns.

“Novo Nordisk takes the PADE reporting requirements seriously and we plan to respond to the requests contained in the warning letter in a timely and comprehensive manner,” the statement said. referring to safety reports sent to the FDA after a drug is approved.