The FDA has formally reprimanded Novo Nordisk for repeatedly failing to report serious adverse events-including patient deaths-linked to its blockbuster GLP-1 drugs Ozempic and Wegovy.
In a March 5 warning letter, the agency cited five specific cases where patients suffered strokes, suicidal ideation, or died while taking semaglutide-based medications. Novo Nordisk did not submit these reports as required under federal law, which mandates that all serious adverse events be reported within 15 days, regardless of whether causation is suspected.
The FDA accused the company of “systemic failures” in its pharmacovigilance systems, including policies that allowed call-center staff to dismiss reports if patients or doctors didn’t believe the drug was responsible. In one case, a man who died while on semaglutide was never reported to the FDA-even though his identifying information existed in internal records.
Following a January 2025 inspection, regulators found Novo Nordisk’s internal procedures violated reporting standards by requiring patient consent for follow-up-a step not mandated by the FDA. Though the company has since revised this policy, the agency called its corrective actions “inadequate.”
This marks the third FDA warning letter to Novo Nordisk in six months, following prior violations involving contaminated vials and misleading promotional content.
Over 5,000 patients have filed lawsuits alleging the company downplayed risks like intestinal blockages, neurological damage, and vision loss. Lead attorney Jonathan Orent called the FDA findings “validation” of long-standing claims and warned the underreporting may extend beyond GLP-1 drugs.
Novo Nordisk maintains its medicines are safe when used as directed and says it is addressing the FDA’s concerns. A spokesperson emphasized that adverse event reports do not prove causation-only temporal association.
Still, with over 31 million Americans now using GLP-1 medications, the scrutiny raises urgent questions about post-market drug safety oversight.