Maker of Ozempic, Wegovy Failed to Report Strokes, Suicidal Ideation and Deaths
Source: Children’s Health Defense
The maker of several blockbuster weight-loss drugs failed to report serious side effects, including strokes, suicidal ideation and deaths, according to the U.S. Food and Drug Administration (FDA).
The FDA this month issued a formal warning letter to Novo Nordisk, reprimanding the pharmaceutical giant for “serious violations” in failing to report serious side effects linked to Ozempic, Wegovy and Saxenda.
The March 5 letter followed FDA inspections, conducted in January and February, of Novo Nordisk’s U.S. operations in Plainsboro, New Jersey.
Investigators concluded the company failed to comply with federal regulations governing the reporting of post-marketing adverse drug experiences (PADE) — a critical safety system used to detect safety signals after the drugs are already on the market.
Under federal law, pharmaceutical companies must promptly report all serious reports of adverse events to the FDA within 15 days of receiving the report, so regulators can monitor emerging risks to consumers.
However, Novo Nordisk — in violation of the law — chose not to report serious adverse events, including strokes and patient deaths, after their staff or contractors decided the side effects weren’t related to the drugs.
Investigators found the drugmaker also failed to follow some of its own internal procedures, including making follow-up attempts to obtain safety information for serious cases involving reported deaths.
In post-inspection correspondence with the agency, the company said it was taking “corrective and preventative actions” to address the violations.
Still, the FDA slapped the company with the warning letter because it said Novo’s response did not provide sufficient details to demonstrate whether those actions would effectively resolve the issues.
Novo failed to report suicidal ideation, deaths and stroke linked to the drugs
The FDA letter outlines a series of flawed arguments Novo used to justify its failure to report different events.
The letter detailed the case of a patient who experienced a disabling stroke after taking liraglutide (Saxenda). The company didn’t report it because it said the consumer didn’t think the stroke was related to the drug.
In another case, a physician reported that a patient taking semaglutide committed suicide. Novo opted not to investigate the case.
The company reported a different case of suicidal ideation to the FDA only after agency inspectors stumbled on the record when they were investigating the unreported stroke death.
Independent studies have linked the drugs to suicidal ideation.
In another case, Novo said it didn’t investigate a patient death involving semaglutide (Ozempic, Wegovy) because the company hadn’t received consent from the person who reported the death. According to the FDA, consent isn’t required for PADE investigation.
The FDA also found that even after the agency warned Novo that it was violating the law, its contractors continued to “inappropriately invalidate” cases of serious adverse events. The company claimed the events were invalid because they lacked patient identifiers — protected information, such as name or social security number that links a person to their health record.
However, FDA inspectors found valid patient identifiers in the source documents for the company’s internal reports, according to the letter.
Systemic failures that implicate Novo’s ‘entire product portfolio’
These instances of failed reporting were not isolated events. Instead they “suggest systemic failures” in how the company receives, evaluates and reports safety data to federal authorities, the FDA said.
“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 FDA told the company.
Novo officials defended the company in a statement posted on its website, indicating it “has been working to resolve the observations” in the letter.
“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” said Anna Windle, head of Clinical Development, Medical and Regulatory Affairs, Novo Nordisk U.S.
Adverse event reporting systems are cornerstones of drug safety monitoring. If problems aren’t reported early and accurately, regulators could miss early signals that a drug is causing harm.
Drug safety experts have long warned that post-marketing surveillance systems depend heavily on manufacturers to report safety data accurately, raising concerns about potential conflicts of interest.
Many medical journals have called for better adverse event reporting, particularly in the wake of major scandals, such as Merck’s withdrawal of Vioxx from the market after it led to tens of thousands of cardiac issues and deaths.
The FDA this week launched a new system for monitoring adverse events, claiming it will improve efficiency and transparency. While some applauded the new Adverse Event Monitoring System, or AEMS, some critics suggested the new system doesn’t address all of the longstanding issues with the systems it’s intended to replace.
FDA orders response within 15 days
Warning letters are among the FDA’s most serious enforcement tools short of legal action. They notify companies of significant regulatory violations and require prompt corrective measures to avoid further enforcement steps.
Novo Nordisk must respond within 15 working days with a detailed explanation of corrective actions.
If the FDA determines the company’s response is inadequate, the agency can pursue additional enforcement measures, including fines, product seizures or injunctions.
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Company faces 4,000 lawsuits in U.S. for life-altering side effects
Global demand for Novo’s weight-loss drugs — the class of drugs known as GLP-1 receptor agonists — skyrocketed in recent years, fueled by aggressive marketing.
The drugs, also made by Novo competitor Eli Lilly, have become some of the most profitable pharmaceutical products in the world.
GLP-1 drugs increasingly are touted as a cure-all for problems beyond weight loss — including everything from addiction to long COVID to Alzheimer’s disease.
In the U.S. today, about 1 in 8 adults — an estimated 31 million people — say they are on a GLP-1 drug. About 1 in 5 adults have taken them at some point, according to a November 2025 KFF News poll.
However, the rapid expansion of these drugs has also been accompanied by increasing reports of effects, including gastrointestinal problems, acute pancreatitis, higher rates of gallbladder and biliary disease, kidney stones, arthritis, sleep disturbances, dental decay, malnutrition, hair loss, and loss of bone density and muscle mass.
The drugs may also be linked to cancer. Research also shows they may have psychological side effects, including causing apathy among users.
More than 4,000 Americans have sued drugmakers alleging the drugs caused life-altering side effects that the companies never warned them about, The Independent reported Thursday.
Plaintiffs include family members of people who died suddenly after taking the drug. Others include people who said the drugs caused them to develop non-arteritic anterior ischemic optic neuropathy (NAION), which causes vision loss.
A study published last week in the British Journal of Ophthalmology found that among the 1 in 10,000 people taking the drugs who suffer from NAION, Ozempic users are far more likely than Wegovy users to suffer the condition.
In December 2024, Novo told The Defender that it had done a thorough internal investigation and found no link between NAION and its drugs.
In June 2025, the European Medicines Agency confirmed that the drugs were linked to NAION. The condition is listed on the European label, but still does not appear as a side effect on Ozempic’s U.S. label. It says only that patients should contact their physician if they experience vision changes.
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