FDA Warns Novo Nordisk Over Unreported Side Effects of Ozempic and Wegovy

The Food and Drug Administration has sent Novo Nordisk, the maker of Ozempic and Wegovy, a warning letter over how the company reports possible side effects of semaglutide, the active ingredient in both drugs, according to CBS News and NBC News. The letter is dated March 5 and was reported Tuesday.

The agency cited “serious violations” in the company’s reporting of adverse drug events, NBC News reported. It pointed to three deaths among patients taking semaglutide, one of them a suicide, that the company allegedly did not report to the FDA within the required time frame, according to NBC News and CBS News. NBC News added that the letter said Novo Nordisk failed to investigate or report the suicide. CBS News added that the letter also describes another patient who reported suicidal thoughts while taking the drug.

Both outlets stressed what the letter does not say. The FDA did not say the medications caused the deaths or other side effects, NBC News reported, and CBS News said the letter focused on the company’s apparent failure to follow its reporting protocols, not on whether the drug was responsible. “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 agency wrote, using the abbreviation for adverse drug events, per NBC News.

The findings came from an inspection of Novo Nordisk’s U.S. headquarters in Plainsboro, New Jersey, in early 2025, CBS News reported. The inspection was part of the FDA’s Bioresearch Monitoring Program, which aims to ensure that accurate and timely safety information reaches the agency. NBC News described the site as a Novo Nordisk facility in New Jersey inspected last year.

Novo Nordisk responded Tuesday in a statement, saying it had been “working diligently” to address the agency’s concerns since the inspection, according to CBS News. The company said the letter largely seeks more detail on the steps it has taken to comply with rules on post-marketing adverse drug experience reporting, known as PADE, and does not “make any conclusions about the quality or safety of our medicines.” “Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” Anna Windle, head of clinical development, medical and regulatory affairs at Novo Nordisk U.S., said, per CBS News and NBC News. The company said it is confident it will resolve the matters to the FDA’s satisfaction.

The letter arrives against a backdrop of earlier FDA safety reviews of the drug class. CBS News reported that another recent FDA evaluation found no connection between suicide and GLP-1 drugs such as Ozempic and Wegovy, and that in January the agency asked for the removal of boxed warnings for suicidal behavior or ideation from those medications. Ozempic is a diabetes drug that is also prescribed for weight loss, CBS News noted, and NBC News called the products blockbuster medications.