In March, the Food and Drug Administration issued a warning letter to Novo Nordisk, the Danish pharmaceutical company that manufactures Ozempic and Wegovy, for failing to report deaths and adverse events associated with its GLP-1 receptor agonist drugs. [1] The letter, first reported by Bloomberg and subsequently covered by Forbes, Reuters, and People, stated that Novo Nordisk had not submitted required safety reports for at least three deaths and multiple serious side effects that the company knew about or should have known about. [2]

The FDA's adverse event reporting system requires pharmaceutical manufacturers to submit reports of deaths, hospitalizations, and serious side effects within 15 days of becoming aware of them. The warning letter indicated that Novo Nordisk's reporting gaps spanned months, not days. Forbes reported that the failures involved cases where patients had died or been hospitalized after taking semaglutide -- the active ingredient in both Ozempic and Wegovy -- and the company had received the information through its own pharmacovigilance systems but had not forwarded it to the FDA. [1]

Novo Nordisk's semaglutide products generated approximately $21 billion in global revenue in 2025. The drugs are prescribed to more than 15 million Americans for Type 2 diabetes (Ozempic) and weight management (Wegovy). At that scale, adverse events are statistically inevitable. The question the FDA's letter raises is not whether people taking semaglutide sometimes die -- they do, as with any widely prescribed medication -- but whether the company responsible for tracking and reporting those events is doing so with the rigor that the law requires and that 15 million patients deserve.

The warning letter arrived alongside a separate but related FDA enforcement action. Reuters reported that the agency sent warning letters to approximately 30 telehealth companies over misleading marketing of GLP-1 drugs, including claims about compounded semaglutide that the FDA considers unsubstantiated. [3] The Hill reported that several of the telehealth firms had been marketing compounded versions of semaglutide -- pharmacy-prepared alternatives to the branded products -- with claims about safety and efficacy that have not been reviewed by the FDA. [4]

The compounding issue is distinct from Novo Nordisk's reporting failures but feeds the same underlying problem: demand for GLP-1 drugs has outstripped both supply and oversight. The shortage of branded Ozempic and Wegovy, which persisted through most of 2024 and into 2025, drove patients toward compounding pharmacies and telehealth platforms that could provide semaglutide without the supply constraints. The FDA placed semaglutide on its drug shortage list, which legally permits compounding pharmacies to produce copies. When the FDA removed semaglutide from the shortage list in late 2025, it triggered a legal battle over whether compounding pharmacies could continue producing it. [3]

People magazine reported that the combination of the Novo Nordisk warning and the telehealth crackdown represents the FDA's most aggressive intervention in the GLP-1 market since the drugs became cultural phenomena. [5] The magazine framed the story around patient safety, noting that individuals who obtained compounded semaglutide through telehealth platforms may not have received the same product, dosage, or monitoring that a branded prescription would provide.

The market has largely shrugged. Novo Nordisk's stock dipped less than 2 percent on the warning letter and recovered within the week. The company issued a statement saying it "takes its pharmacovigilance obligations seriously" and was "working with the FDA to address the matters raised." The 30 telehealth firms have not issued coordinated responses. The patients who take these drugs every week -- injecting a peptide that suppresses their appetite, lowers their blood sugar, and may be doing things to their bodies that the adverse event reports are supposed to capture -- continue to inject.

The FDA can warn. It warned. Whether warning changes anything when the drug in question generates $21 billion a year is a question the agency's enforcement history answers clearly: it usually does not.

-- Nora Whitfield, Chicago