Novo Nordisk failed to report deaths of weight-loss drug patients

Novo Nordisk, maker of the popular weight-loss drugs Ozempic and Wegovy, is under fire from the federal government for failing to regularly report possible side effects of its GLP-1 drugs, including deaths.

One Warning letter dated March 5The Food and Drug Administration cited five cases in which patients taking the drugs suffered strokes, were ruled suicides, or died; one of which was suicide, and Novo Nordisk did not report all of them properly.

Novo Nordisk’s actions “indicate systemic failures in the surveillance, receipt, evaluation and reporting” of potential side effects, the FDA wrote in its warning letter to the company.

Novo Nordisk representatives did not provide the exact number of affected patients when asked, but USA TODAY’s analysis of FDA data shows a large increase in adverse event reports the company filed in July 2025, just a few months after the inspection.

In just one week, the company submitted nearly 11,000 adverse event reports related to semaglutide, the active ingredient in the drugs Ozempic and Wegovy. More than 1,800 of these were classified as serious; companies must submit it to the FDA within 15 days and can include death or other life-threatening reactions.

The remaining 9,100 reports on semaglutide submitted that week were listed as nonserious reactions, which included adverse effects that did not require major medical attention, such as nausea or vomiting.

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Novo Nordisk declined to disclose the timing of these filings, but a spokesperson said the company is committed to addressing all reporting issues found during an FDA inspection of Novo Nordisk facilities last year and mentioned again in this new warning letter.

“We stand behind the safety and effectiveness of all of our GLP-1 RA medications when used as directed and under the supervision of a licensed healthcare professional,” Liz Skrbkova, senior director of U.S. media and stakeholder relations for Novo Nordisk, said in an emailed statement.

He noted an important caveat in the FDA system for reporting unwanted side effects: Reports do not prove that a drug caused a particular reaction, only that the patient was taking the drug when it occurred.

“More importantly, the FDA did not say that the drugs caused these events, but rather that Novo Nordisk did not properly report them. This is an important distinction,” Skrbkova said. “We recognize that seeing terms such as ‘death’ or ‘serious adverse event’ in these types of FDA communications may be shocking to many people. However, it is not uncommon to see this type of language in (this) reporting.”

Thousands of patients have filed lawsuits against Novo Nordisk, claiming the company understates the health risks of GLP-1 drugs. Jonathan Orent, the lead attorney representing the plaintiffs in the federal lawsuits, said the legal team has identified a significant number of additional side effects that they believe were still not reported to the FDA.

The FDA called the warning letter’s list of five cases “a significant understatement of the problem facing the company and, more concerning, a failure to provide doctors and patients with the information they need to make a meaningful choice about which drug to take.”

The FDA has not announced punitive measures against the company, but warning letters typically serve as an early step Identifying violations of federal law and allowing companies to correct them.

This month’s warning letter is the third warning letter the company has received in the past six months, following a recent one from the FDA. Animal hair found in medicine bottles A promotional video for weight-loss drugs was shot at a facility in Indiana. false and misleading.

What is Novo Nordisk doing wrong?

FDA’s new letter lists several scenarios that inspectors found when they visited Novo Nordisk facilities in January 2025; These include examples where the company failed to investigate reports of side effects, improperly dismissed those reports, or delayed reporting them to the government.

federal law It requires drug manufacturers to submit reports of potential serious side effects to the FDA within 15 days, regardless of whether patients or doctors believe the side effect is directly related to the drug.

According to the FDA, Novo Nordisk’s written internal policy allowed call center operators to reject reports if patients or doctors said they did not believe the company’s drugs caused an undesirable side effect. As an example, the FDA cites a consumer taking liraglutide, the active ingredient in Novo Nordisk’s weight-loss and diabetes drugs Victoza and Saxenda. Novo Nordisk dismissed the case because the consumer did not believe that the stroke he experienced was drug-related.

Government investigators also accuse Novo Nordisk’s call centers of publishing the reports because they were missing critical details needed to identify patients. The letter stated that this occurred in the case of a man who died while taking semaglutide, the active ingredient in Ozempic and Wegovy. Novo Nordisk never reported his case to the federal government, although FDA investigators later found his personal details in case documents.

Novo Nordisk’s internal policies direct employees to make two follow-up attempts to complete missing details. But the company’s written policies also allowed employees to ignore direct reports from patients whose consent for follow-up was not requested.

The letter states that FDA regulations do not require such consent and accuses Novo Nordisk of failing to investigate a case in which a patient taking semaglutide became depressed and considered suicide, as well as a patient who died while taking semaglutide.

The FDA’s letter acknowledges that Novo Nordisk has updated its policies to eliminate the unnecessary authorization requirement since the 2025 inspection and that the company is reviewing cases to ensure follow-ups are carried out. But the government says those efforts are insufficient and questions Novo Nordisk’s ability to monitor drug safety and inspect call centers on a larger scale.

“Based on the nature of the audit findings and your written response and correspondence, we have serious concerns about the scope of these violations and the impact on your entire product portfolio,” the letter concluded.

Thousands of patients sue GLP-1 drug manufacturers

It is estimated that approximately 12% of American adults (more than 31 million people) are currently using a GLP-1 drug. non-partisan health policy organization KFF.

Most of these patients lost weight with little discomfort other than stomach upset or nausea. But a growing number of patients — at least 5,000 as of March 16 — have filed suit in consolidated federal and state lawsuits, alleging the drugmakers failed to adequately warn of the risk of serious injuries, including blindness, neurological disorders and intestinal blockages.

In addition to Novo Nordisk, the lawsuits also target Indiana-based Eli Lilly, which makes Trulicity, Mounjaro and Zepbound. Drug manufacturers have generally denied the allegations and said they would strongly defend the safety of the drug.

More: Weight loss drugs attract thousands of lawsuits alleging serious harm

Orent, the lead attorney who represents thousands of plaintiffs in the multidistrict federal lawsuit, said the latest FDA warning letter and last year’s review provide important validation of his clients’ claims since they first filed the lawsuit nearly three years ago.

“Frankly, it’s scary because we represent people whose real-life health has been negatively impacted by these (drug manufacturers’) failures. And it’s only now that the FDA is really taking action to find out,” Orent said. This letter “reassures me that not only are we right, but the government is now doing something about these problems.”

Orent’s legal team is working with academics and former FDA employees who may eventually serve as expert witnesses at the trial, and Orent said investigators were stunned by what they found.

“One person’s reaction was that they hadn’t seen anything that bad, except perhaps in the opioid days,” Orent said, referring to previous lawsuits accusing pharmaceutical companies of fueling the opioid epidemic.

Orent echoed the FDA’s concern that these problems with reporting possible side effects may be more widespread across Novo Nordisk’s drug portfolio than those of GLP-1 drug monitors examined last year.

“People who are on other medications, who are actively looking at data, who are actively looking at emails, and who don’t have lawyers who are actively taking depositions, I’m frankly afraid that those people will never know what an impact this is having on their health,” Orent said.

One Statement published on Novo Nordisk’s website on March 10The company emphasized that the FDA’s latest letter largely sought more information on how it remains compliant with regulations.

“No conclusions are drawn about the quality or safety of our medicines,” the company statement says.

“Novo Nordisk takes (adverse post-marketing drug experience) reporting requirements seriously and we plan to address the requests in the warning letter promptly and holistically,” Anna Windle, head of clinical development, medical and regulatory affairs for Novo Nordisk USA, wrote in the company statement. “We are confident that we will resolve the issues identified in the warning letter to the FDA’s full satisfaction.”

This article first appeared on USA TODAY: FDA says Ozempic maker ignored reports of deaths and side effects