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.
The remaining 9,100 reports about semaglutide submitted that week were listed as non-serious reactions, which include undesired effects that don’t require major medical intervention, such as nausea or vomiting.
Novo Nordisk declined to explain the timing of these submissions, but a spokesperson said the company is committed to addressing all the reporting issues found during last year’s FDA inspection of Novo Nordisk facilities and mentioned again in this new warning letter.
“We stand behind the safety and efficacy of all of our GLP-1 RA medicines when they are used as indicated and when taken under the care of a licensed healthcare professional,” said Liz Skrbkova, Novo Nordisk’s senior director of U.S. media and stakeholder relations, via an emailed statement.
She pointed out an important caveat in the FDA system for reporting undesired side effects: The reports do not prove that a drug caused a particular reaction but simply that a patient was taking the drug when it happened.
“Importantly, the FDA did not say the medications caused these events but rather that Novo Nordisk did not report them properly. That’s an important distinction,” Skrbkova said. “We recognize that it may be shocking for many to see terms such as ‘death’ or ‘serious adverse event’ in these types of FDA communications. However, it is not uncommon to see that type of language in (this) reporting.”
Thousands of patients have already filed lawsuits against Novo Nordisk, alleging the company understated the health risks of its GLP-1 drugs. Jonathan Orent, a lead attorney representing plaintiffs in federal cases, said their legal team has identified significant numbers of additional side effects they believe still haven’t been reported to the FDA.
He called the FDA warning letter’s list of five cases “a significant understatement of the problem facing the company and, more alarmingly, a failure to provide doctors and patients necessary information for them to make a meaningful choice on which drug to take.”
The FDA has not announced punitive measures against the company, but its warning letters typically serve as an early step to identify violations of federal law and allow companies to rectify them.
This month’s warning letter is the third the company has received in the past six months, after the FDA recently found animal hair in drug vials at an Indiana facility and deemed a promotional video about weight-loss drugs to be false and misleading.
What Is Novo Nordisk Doing Wrong?
The FDA’s new letter ticks through various scenarios inspectors found when they visited Novo Nordisk facilities in January 2025, including examples in which the company failed to investigate reports of side effects, improperly dismissed them or delayed reporting to the government.
Federal law requires drug manufacturers to forward 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 dismiss reports if patients or doctors said they didn’t believe the company’s drugs had caused the unintended 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. The consumer didn’t believe the stroke they’d suffered was related to the drug, so Novo Nordisk dismissed the case.
Government inspectors also accuse Novo Nordisk’s call centers of throwing out reports because they were missing critical details needed to identify patients. The letter said this happened 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 even though FDA inspectors later found his personal details within the case documents.
Novo Nordisk’s internal policies direct employees to make two follow-up attempts to fill in any missing details. However, the company’s written policies also allowed employees to dismiss reports coming directly from patients who were not asked for their consent to follow up.
The letter points out that FDA regulations don’t require obtaining this type of consent, and it accuses Novo Nordisk of failing to investigate a case where a patient using semaglutide was depressed and considering suicide, as well as a patient who died while taking semaglutide.
The FDA’s letter acknowledges that Novo Nordisk has updated its policies since the 2025 inspection to remove the unnecessary consent requirement, and that the company is reviewing cases to ensure follow-ups occurred. However, the government calls these efforts inadequate, questioning Novo Nordisk’s ability to monitor drug safety and oversee its call centers on a broader scale.
“Based on the nature of the inspection’s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio,” the letter concluded.
Thousands of Patients Suing GLP-1 Drugmakers
Approximately 12% of American adults – or more than 31 million people – are currently using a GLP-1 drug, according to estimates from the nonpartisan health policy organization KFF.
Many of these patients have lost weight with little discomfort other than an upset stomach or nausea. However, a growing number of patients – at least 5,000 as of March 16 – have filed suit in consolidated federal and state litigation, alleging the drugmakers failed to sufficiently warn of the risk of severe injuries, including blindness, neurological disorders and intestinal blockages.
The lawsuits target the Novo Nordisk but also Indiana-based Eli Lilly, which makes Trulicity, Mounjaro and Zepbound. The drugmakers have broadly refuted the allegations and said they will vigorously defend the drugs’ safety.
Orent, a lead attorney representing thousands of plaintiffs in the multidistrict federal litigation, said the recent FDA warning letter and last year’s inspection provide important validation of what his clients have been alleging since filing the first lawsuits nearly three years ago.
“Quite frankly, it’s scary because we represent people whose real-life health has negatively been affected because of these (drugmakers’) failures. And only now is the FDA actually taking action to learn about it,” Orent said. This letter “gives me tremendous comfort both that we’re right, but also that the government is actually now doing something about these problems.”
Orent’s legal team has been working with academics and former FDA employees who could eventually serve as expert witnesses at trial, and he said they were stunned by what inspectors found.
“To a person, the reaction was that they had not seen anything quite that bad, with the exception of perhaps during the opioid days,” Orent said, referring to earlier lawsuits accusing pharmaceutical companies of fueling the opioid epidemic.
Orent echoed the FDA’s concern that these problems with reporting possible side effects could be more widespread across Novo Nordisk’s portfolio of medications than just the GLP-1 drugs inspectors reviewed last year.
“People who are taking other drugs, who don’t have lawyers actively looking at data, actively looking at emails and actively taking testimony, I’m quite honestly afraid that those people may never know what impact that had on their health,” Orent said.
In a statement posted to Novo Nordisk’s website on March 10, the company emphasized that the FDA’s recent letter is largely seeking more information about how it stays in line with regulations.
“It does not make any conclusions about the quality or safety of our medicines,” the company statement reads.
“Novo Nordisk takes (postmarketing adverse drug experience) reporting requirements seriously, and we plan to address the requests in the warning letter expeditiously and holistically,” wrote Anna Windle, head of clinical development, medical and regulatory affairs for Novo Nordisk US, via the company statement. “We are confident that we will resolve the matters outlined in warning letter to the FDA’s full satisfaction.”
This article originally appeared on USA TODAY: FDA: Novo Nordisk failed to report deaths of weight-loss drug patients
Reporting by Austin Fast, USA TODAY
USA TODAY Network via Reuters Connect
