FDA Warns Novo Nordisk Over Reporting of Ozempic and Wegovy Side Effects
The U.S. Food and Drug Administration (FDA) issued a warning letter to Novo Nordisk, the manufacturer of Ozempic and Wegovy, citing serious violations in its reporting of potential adverse events associated with the medications. The concerns center around the timely and accurate reporting of side effects, including deaths, to the agency.
FDA Findings and Allegations
The FDA’s warning letter, dated March 5, 2026, details issues discovered during an inspection of Novo Nordisk’s U.S. Headquarters in Plainsboro, Fresh Jersey, in early 2025 [CBS News]. The agency cited three deaths among patients receiving semaglutide – the active ingredient in both Ozempic and Wegovy – that were allegedly not reported correctly. One of these deaths was a suicide, and another involved a patient reporting suicidal ideation [NBC News].
The FDA emphasized that the letter does not conclude whether the deaths or side effects were directly caused by the medications. Instead, the focus is on Novo Nordisk’s failure to adhere to protocols for reporting adverse drug events (ADEs) [NBC News].
Specifically, the FDA noted an instance where a patient reported a stroke even as taking liraglutide, another GLP-1 medication. The company rejected this case, stating the patient believed the stroke was unrelated to the drug, and consequently failed to report the serious adverse event to the FDA within the required 15-day timeframe [The Hill].
Novo Nordisk’s Response
Novo Nordisk acknowledged the FDA’s concerns and stated it has been “working diligently” to address them since the inspection last year [CBS News]. The company indicated that the warning letter primarily requests further details regarding the steps taken to comply with post-marketing adverse drug experience (PADE) regulations. Novo Nordisk maintains that the letter does not make any conclusions about the quality or safety of its medications [CBS News].
Background on Ozempic and Wegovy
Ozempic and Wegovy are both semaglutide-based medications used to treat type 2 diabetes and obesity, respectively. They belong to a class of drugs called GLP-1 receptor agonists, which work by mimicking a natural hormone that helps regulate blood sugar and appetite.
FDA’s Next Steps
The FDA has requested that Novo Nordisk notify the agency within two weeks of the actions it will take to prevent future violations [NBC News].