The manufacturer of popular weight-loss drugs Ozempic and Wegovy, Novo Nordisk, is taking heat from the federal government for regularly failing to report potential side effects of its GLP-1 medications, including deaths.
In a warning letter dated March 5, the Food and Drug Administration cited five cases where patients taking the drugs experienced a stroke, considered suicide or died – one of them by suicide – all of which Novo Nordisk failed to report properly.
Novo Nordisk’s actions, the FDA wrote in its warning letter to the company, “suggest systemic failures with your surveillance, receipt, evaluation, and reporting” of potential side effects.
Novo Nordisk representatives did not provide the specific number of patients affected when asked, but USA TODAY’s analysis of FDA data shows a large spike in the company’s submissions of side effect reports in July 2025, just a few months after the inspection.
In one week alone, the company submitted nearly 11,000 reports of side effects involving semaglutide, the active ingredient in its Ozempic and Wegovy drugs. More than 1,800 of those were categorized as serious, which companies are required to submit to the FDA within 15 days and can include death or other life-threatening reactions.
