FDA Warns Novo Nordisk for Underreporting Ozempic and Wegovy Adverse Events

The FDA issued a warning letter to Novo Nordisk for serious postmarketing adverse drug event reporting violations related to the GLP-1 drugs Ozempic and Wegovy, citing three deaths (including a suicide) and a stroke report; the agency said Novo Nordisk failed to report deaths within the 15-day window and did not adequately investigate or report the suicide, though authorities have recently found no proven link between GLP-1s and suicide. Novo Nordisk has 15 days to report adverse reactions and two weeks to describe corrective actions; the company says it is addressing the concerns.