Did Ozempic manufacturer Novo Nordisk hide drug death reports? Here’s what FDA said about side-effect reporting

The manufacturer of blockbuster weight-loss and diabetes medications Ozempic and Wegovy is facing scrutiny from U.S. regulators after the Food and Drug Administration (FDA) accused Novo Nordisk of failing to properly report several serious side-effect cases, including deaths, as per a report by USA Today.

In a warning letter issued earlier this month, the FDA said Novo Nordisk did not adequately submit reports involving patients who experienced severe health complications while taking drugs containing semaglutide, the active ingredient in Ozempic and Wegovy.

The regulator said the findings raise concerns about the company’s monitoring and reporting systems for potential adverse reactions.

FDA Warning Raises Questions Over Ozempic Reporting

The FDA’s letter highlighted five cases involving patients taking semaglutide medications such as Ozempic, where incidents including stroke, suicidal thoughts and deaths were allegedly not reported correctly.

According to the agency, the lapses point to potential “systemic failures” in how Novo Nordisk tracks and communicates drug-related safety issues to regulators.

Pharmaceutical companies are required under U.S. law to report serious adverse events to the FDA within 15 days, even if the link between the drug and the medical event is uncertain.

The agency’s letter suggests the company did not always follow that rule.

Surge in Side-Effect Reports After Inspection

An analysis of FDA data shows a sharp increase in adverse event reports from Novo Nordisk shortly after regulators inspected company facilities in early 2025.

In one week in July 2025, the company submitted nearly 11,000 reports related to semaglutide drugs such as Ozempic and Wegovy.

Of those, more than 1,800 cases were categorized as serious, meaning they involved life-threatening reactions, hospitalization, disability or death, as per the USA Today report.

The remaining reports involved non-serious side effects including nausea and vomiting, which are among the most commonly reported symptoms associated with GLP-1 medications.

Overall, Novo Nordisk has submitted more than 50,000 semaglutide-related reports since 2020, including at least 600 deaths, according to FDA data.

However, such reports do not prove that the medication directly caused the event, only that the patient experienced the issue while taking the drug.

Novo Nordisk Defends Safety of Ozempic

In response to the FDA warning, Novo Nordisk said it remains confident in the safety profile of its GLP-1 medications, including Ozempic.

Company representatives emphasized that adverse event reports alone do not establish a direct cause-and-effect relationship between a drug and a medical condition.

The company also stated it is working to address the concerns outlined in the warning letter and improve its reporting procedures.

“Novo Nordisk takes reporting requirements seriously and is committed to resolving the issues raised by the FDA,” the company said in a statement, as per a report by USA Today.

Regulators noted that the company has already updated some internal policies since the inspection.

What the FDA Says Went Wrong

The FDA’s inspection revealed several scenarios where Novo Nordisk allegedly mishandled reports of side effects linked to Ozempic and similar drugs.

In some cases, call-center staff reportedly dismissed complaints if patients or doctors believed the medication was not responsible for the medical issue.

In other cases, reports were discarded because they lacked certain personal details needed to identify the patient.

For example, the agency cited an instance where a patient taking semaglutide reportedly died, but the case was never forwarded to regulators despite documentation containing relevant information.

The FDA said these practices could undermine efforts to properly monitor drug safety.

Lawsuits Mount Against GLP-1 Drugmakers

The warning letter comes as legal challenges against manufacturers of GLP-1 medications continue to grow.

Thousands of patients have filed lawsuits claiming companies such as Novo Nordisk failed to adequately warn users about potential risks associated with drugs like Ozempic.

Some lawsuits allege severe health complications, including intestinal blockages, neurological disorders and vision problems.

Legal experts say the FDA’s latest warning could become a significant element in ongoing litigation.

Growing Popularity of Ozempic

Despite the controversy, drugs like Ozempic remain among the most widely used weight-loss and diabetes treatments in the United States.

Health policy estimates suggest more than 31 million American adults are currently using GLP-1 medications.

Many patients report successful weight loss with manageable side effects, though regulators continue to monitor the drugs’ long-term safety.

The FDA has not yet announced any penalties against Novo Nordisk, but warning letters are typically issued as an initial step requiring companies to correct regulatory violations.

FAQs

What did the FDA accuse Novo Nordisk of doing?

The FDA said Novo Nordisk failed to properly report several serious adverse events, including deaths and suicide-related cases involving patients taking Ozempic and other semaglutide drugs.

Does the FDA say Ozempic caused these deaths?

No. The FDA said the incidents were not proof that Ozempic caused the events, only that the company failed to report them correctly.