The US Food and Drug Administration has accused Novo Nordisk of 'serious violations' in its safety reporting systems, revealing that the Danish drugmaker failed to report three patient deaths involving its blockbuster diabetes drug Ozempic within mandatory timeframes.
The FDA's 5 March warning letter does not claim Ozempic caused the deaths. Instead, it exposes a systemic breakdown in how Novo Nordisk monitors and reports adverse events, raising questions about whether critical safety signals are reaching regulators in time to protect patients.
