FDA: Novo ignored deaths, side effects
Ozempic maker: GLP-1 drugs safe, effective
By: Austin Fast
USA Today
..... The manufacturer of weight-loss drugs Ozempic and Wegovy, Novo Nordis, is taking heat from the federal government for regularly failing to report potential side effects of its GLP-1 medications, including deaths.
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In a warning letter dated March 5, [2026] 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 it said Novo Nordisk failed to report properly.
..... Nove Nordusk'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.
..... Company representatives did not provide the specific number of patients affected when asked, but USA today's analysis of FDA shows a large spike in the company's submission of side effects 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 tis Ozempic and Wegovy drug.
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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 their 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.
..... A Novo Nordisk spokesperson said the company is committed to addressing all the reporting issue found during last year's [2025] FDA inspection of Novo facilities.
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"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 Skrbkoka, Novo Nordisk's senior director of U.S. media and stakeholder relations via an emailed statement.
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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.
..... 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 believed 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 letter typically serve as an early step to identify violations of federal law and allow companies to rectify them.
..... The March 5 [2026] 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 weigh-loss drugs to be false and misleading.
..... 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 [2026] - have filed suit in consolidated federal and state litigation, alleging the drug-makers failed to sufficiently warn of the risk of severe injuries.
..... The lawsuit target Nove Nordisk as well as Indiana-based Eli Lilly, which makes Trulicity, Mounjaro and Zepbound. The drug-makers have broadly refuted the allegations.
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Orent, a lead attorney representing thousands of plaintiffs in the multi-district federal litigation, said the recent FDA warning letter and last year's [2025] inspection provide important validation of what his clients have been alleging since filing the first lawsuits nearly three years ago.
..... 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 said.
..... 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.
..... The FDA's March 5 [2026] 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 off 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.
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According to the FDA, Novo'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'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 dismissed the case.
..... Government inspector also accuse Novo Nordisk's call center of throwing out reports because they were missing critical details needed to identify patients. The letter said this happened in the case f a man who died while taking semaglutide, the active ingredient in Ozempic and Wegovy. Novo never reported his case to the federal government even though FDA inspectors later found his information within case documents.