The Food and Drug Administration issued a warning letter to Novo Nordisk — the maker of Ozempic and Wegovy — for failing to report potential side effects in patients who took its blockbuster medications.
In a letter dated March 5, the FDA criticized Novo Nordisk for “serious violations” related to the reporting of possible side effects linked to semaglutide, the active ingredient in Ozempic and Wegovy.
The FDA cited three deaths among patients who took the medications, including one who died by suicide, saying the company did not report them within the agency’s required time frame. It said Novo Nordisk failed to investigate or report the suicide.
The FDA did not say the medications caused the deaths or other side effects.
“FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product’s safety profile and uphold FDA’s mission to protect and promote public health,” the FDA wrote, referring to “adverse drug events.”
It said findings were based on an inspection of a Novo Nordisk facility in New Jersey last year.
The FDA said it is giving Novo Nordisk two weeks to notify it of the actions it will take to prevent future violations.
In a statement published online, Novo Nordisk said it has been working “diligently” to address the FDA’s concerns.
“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” the statement read, referring to safety reports sent to the FDA after a drug's approval.
