FDA flags Novo Nordisk for unreported side effects tied to Ozempic and Wegovy
The FDA sent Novo Nordisk a warning for serious lapses in reporting potential adverse events linked to semaglutide (the active ingredient in Ozempic and Wegovy), citing three deaths including a suicide and saying the company failed to investigate or report them within required timelines after an inspection of a New Jersey facility. Novo Nordisk says it will address the concerns, and the agency gave two weeks to outline corrective actions.