The pharmaceutical titan Novo Nordisk, known for its renowned diabetes medication Ozempic, has found itself under scrutiny from the U.S. Food and Drug Administration (FDA). The FDA has issued a warning letter to the company, expressing concerns regarding their procedures for reporting potential side effects associated with the drug, which is also frequently prescribed for weight loss.
In a letter dated March 5, the FDA highlighted the improper handling of reports concerning three deaths among patients using semaglutide—the active ingredient in both Ozempic and Wegovy. Notably, one of these cases involved a suicide, and another involved a patient experiencing suicidal thoughts while taking the medication, according to the FDA’s findings.
While the FDA has not directly linked these incidents to semaglutide, the agency’s focus is on Novo Nordisk’s apparent non-compliance with the mandatory procedures for reporting adverse events potentially connected to their drug. This oversight was discovered during an inspection at Novo Nordisk’s U.S. headquarters in Plainsboro, New Jersey, conducted in early 2025 as part of the FDA’s Bioresearch Monitoring Program. The program is designed to ensure that companies submit accurate and timely safety information for regulatory scrutiny.
In response to the FDA’s warning, Novo Nordisk issued a statement on Tuesday, emphasizing their commitment to resolving the issues identified. The company explained that the FDA’s letter primarily requested further information on the measures they have implemented since the inspection to adhere to post-marketing adverse drug experience (PADE) regulations. Novo Nordisk stressed that the letter did not question the quality or safety of their medications.
Anna Windle, head of clinical development, medical, and regulatory affairs at Novo Nordisk U.S., stated, “Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically. We are confident that we will resolve the matters outlined in the Warning Letter to the FDA’s full satisfaction.”
“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” said Anna Windle, the head of clinical development, medical and regulatory affairs at Novo Nordisk U.S. “We are confident that we will resolve the matters outlined in Warning Letter to the FDA’s full satisfaction.”
Another recent evaluation by the FDA determined that there was no connection between suicide and GLP-1 drugs such as Ozempic or Wegovy. The agency in January requested the removal of boxed warnings for suicidal behavior or ideation from those medications.
