The U.S. Food and Drug Administration (FDA) has issued a warning to Novo Nordisk over its alleged failure to report adverse side effects, including death, in patients who took its GLP-1 medications, popularly known as Ozempic and Wegovy.
The FDA wrote in a March 5 letter that it observed “serious violations” of reporting requirements during an inspection at a Novo facility in early 2025.
The letter cited three deaths among patients using semaglutide, the active ingredient in several of its weight-loss medications, which it said were not properly investigated or reported. One of those cases involved suicide, according to the FDA.
The agency accused Novo of violating procedures that required the company to perform follow-ups in cases where death occurred. The FDA also said the company failed to report adverse reactions to the medication within the required 15-day timeframe.