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<\/a><\/p>\nThe\u00a0maker of several blockbuster weight-loss drugs<\/a>\u00a0failed to report serious side effects, including strokes, suicidal ideation and deaths, according to the U.S. Food and Drug Administration (FDA).<\/p>\n The FDA this month issued a formal\u00a0warning letter to Novo Nordisk<\/a>, reprimanding the pharmaceutical giant for \u201cserious violations\u201d in failing to report serious side effects linked to\u00a0Ozempic<\/a>,\u00a0Wegovy<\/a>\u00a0and\u00a0Saxenda<\/a>.<\/p>\n The March 5 letter followed FDA inspections, conducted in January and February, of Novo Nordisk\u2019s U.S. operations in Plainsboro, New Jersey.<\/p>\n Investigators concluded the company failed to comply with federal regulations governing the reporting of post-marketing adverse drug experiences (PADE) \u2014 a critical safety system used to detect safety signals after the\u00a0drugs<\/a>\u00a0are already on the market.<\/p>\n Under\u00a0federal law<\/a>, 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.<\/p>\n However, Novo Nordisk \u2014 in violation of the law \u2014 chose not to report serious adverse events, including strokes and patient deaths, after their staff or contractors decided the side effects weren\u2019t related to the drugs.<\/p>\n 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.<\/p>\n In post-inspection correspondence with the agency, the company said it was taking \u201ccorrective and preventative actions\u201d to address the violations.<\/p>\n Still, the FDA slapped the company with the warning letter because it said Novo\u2019s response did not provide sufficient details to demonstrate whether those actions would effectively resolve the issues.<\/p>\n The\u00a0FDA letter<\/a>\u00a0outlines a series of flawed arguments Novo used to justify its failure to report different events.<\/p>\n The letter detailed the case of a patient who experienced a disabling stroke after taking liraglutide (Saxenda). The company didn\u2019t report it because it said the consumer didn\u2019t think the stroke was related to the drug.<\/p>\n In another case, a physician reported that a patient taking semaglutide committed suicide. Novo opted not to investigate the case.<\/p>\n 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.<\/p>\n Independent studies have linked the drugs to\u00a0suicidal ideation<\/a>.<\/p>\n In another case, Novo said it didn\u2019t investigate a patient death involving semaglutide (Ozempic, Wegovy) because the company hadn\u2019t received consent from the person who reported the death. According to the FDA, consent isn\u2019t required for PADE investigation.<\/p>\n The FDA also found that even after the agency warned Novo that it was violating the law, its contractors continued to \u201cinappropriately invalidate\u201d cases of serious adverse events. The company claimed the events were invalid because they lacked\u00a0patient identifiers<\/a>\u00a0\u2014 protected information, such as name or social security number that links a person to their health record.<\/p>\n However, FDA inspectors found valid patient identifiers in the source documents for the company\u2019s internal reports, according to the letter.<\/p>\n Systemic failures that implicate Novo\u2019s \u2018entire product portfolio\u2019<\/strong><\/p>\n These instances of failed reporting were not isolated events. Instead they \u201csuggest systemic failures\u201d in how the company receives, evaluates and reports safety data to federal authorities, the FDA said.<\/p>\n \u201cBased on the nature of the inspection\u2019s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio,\u201d the FDA told the company.<\/p>\n Novo officials<\/a>\u00a0defended the company in a statement posted on its website, indicating it \u201chas been working to resolve the observations\u201d in the letter.<\/p>\n \u201cNovo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,\u201d said Anna Windle, head of Clinical Development, Medical and Regulatory Affairs, Novo Nordisk U.S.<\/p>\n Adverse event reporting systems are cornerstones of drug safety monitoring. If problems aren\u2019t reported early and accurately, regulators could miss early signals that a drug is causing harm.<\/p>\n Drug safety experts have long warned that\u00a0post-marketing surveillance<\/a>\u00a0systems depend heavily on manufacturers to report safety data accurately, raising concerns about potential conflicts of interest.<\/p>\n Many medical journals have called for better adverse event reporting, particularly in the wake of major scandals, such as\u00a0Merck\u2019s withdrawal of Vioxx<\/a>\u00a0from the market after it led to tens of thousands of cardiac issues and deaths.<\/p>\n The FDA this week launched a\u00a0new system for monitoring adverse events<\/a>, claiming it will improve efficiency and transparency. While some applauded the new\u00a0Adverse Event Monitoring System<\/a>, or AEMS, some critics suggested the new system doesn\u2019t address all of the longstanding issues with the systems it\u2019s intended to replace.<\/p>\n FDA orders response within 15 days<\/strong><\/p>\n Warning letters<\/a>\u00a0are among the FDA\u2019s 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.<\/p>\n Novo Nordisk must respond within 15 working days with a detailed explanation of corrective actions.<\/p>\n If the FDA determines the company\u2019s response is inadequate, the agency can pursue additional enforcement measures, including fines, product seizures or injunctions.<\/p>\n The Defender is 100% reader-supported. No corporate sponsors. No paywalls. Our writers and editors rely on you to fund stories like this that mainstream media won\u2019t write.<\/p>\n Company faces 4,000 lawsuits in U.S. for life-altering side effects<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n Global demand for Novo\u2019s weight-loss drugs \u2014 the class of drugs known as GLP-1 receptor agonists \u2014 skyrocketed in recent years, fueled by\u00a0aggressive marketing<\/a>.<\/p>\n The drugs, also made by Novo competitor\u00a0Eli Lilly<\/a>, have become some of the most profitable pharmaceutical products in the world.<\/p>\n GLP-1 drugs increasingly are touted as a cure-all for problems beyond weight loss \u2014 including everything from\u00a0addiction<\/a>\u00a0to\u00a0long COVID<\/a>\u00a0to\u00a0Alzheimer\u2019s disease<\/a>.<\/p>\n In the U.S. today, about 1 in 8 adults \u2014 an estimated 31 million people \u2014 say they are on a GLP-1 drug. About 1 in 5 adults have taken them at some point, according to a November 2025\u00a0KFF News poll<\/a>.<\/p>\n However, the rapid expansion of these drugs has also been accompanied by increasing reports of effects, including\u00a0gastrointestinal problems<\/a>,\u00a0acute pancreatitis<\/a>, higher rates of\u00a0gallbladder and biliary disease<\/a>, kidney stones, arthritis, sleep disturbances,\u00a0dental decay<\/a>,\u00a0malnutrition<\/a>,\u00a0hair loss<\/a>, and loss of\u00a0bone density<\/a>\u00a0and\u00a0muscle mass<\/a>.<\/p>\n The drugs may also be linked to\u00a0cancer<\/a>. Research also shows they may have psychological side effects, including\u00a0causing apathy<\/a>\u00a0among users.<\/p>\n More than 4,000 Americans have sued drugmakers alleging the drugs caused life-altering side effects that the companies never warned them about,\u00a0The Independent\u00a0<\/a>reported Thursday.<\/p>\n Plaintiffs include family members of people who died suddenly after taking the drug. Others include people who said the drugs caused them to develop\u00a0non-arteritic anterior ischemic optic neuropathy<\/a>\u00a0(NAION), which causes vision loss.<\/p>\n A study published last week in the\u00a0British Journal of Ophthalmology<\/a>\u00a0found that among the 1 in 10,000 people taking the drugs who suffer from\u00a0NAION<\/a>, Ozempic users are far more likely than Wegovy users to suffer the\u00a0condition<\/a>.<\/p>\n In December 2024, Novo told The Defender that it had done a thorough internal investigation and found\u00a0no link between NAION and its drugs<\/a>.<\/p>\n In June 2025, the\u00a0European Medicines Agency<\/a>\u00a0confirmed that the drugs were linked to NAION. The condition is listed on the\u00a0European label<\/a>, but still does not appear as a side effect on\u00a0Ozempic\u2019s U.S. label<\/a>. It says only that patients should contact their physician if they experience vision changes.<\/p>\n ____ The FDA reprimanded Novo Nordisk for \u201cserious violations\u201d in failing to report serious side effects tied to its blockbuster GLP-1 drugs, including Ozempic and Wegovy. Investigators said the company didn\u2019t report cases involving strokes, suicidality and patient deaths, raising concerns … Continue reading
\nhttps:\/\/childrenshealthdefense.org\/defender\/novo-nordisk-ozempic-wegovy-fda-warning-letter-fail-report-deaths-side-effects\/?utm_id=20260313<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"