The FDA has reprimanded Novo Nordisk for "serious violations" by not reporting serious side effects associated with its popular GLP-1 medications, including Ozempic and Wegovy. Investigators have stated that the company has not reported cases of strokes, suicidal thoughts and fatal patients, which raises concerns about systemic safety monitoring problems.
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A maker of respective breakthrough weight failure drugs did not study serious side effects, including strokes, suicidal thoughts and deaths, according to the U.S. Food and Drug Agency (FDA).
FDA sent out this period official informing letter to Novo Nordisk, blaming the pharmaceutical giant for "serious violations" by not reporting serious side effects related to Ozempic, Vegovy and Saxenda.
The letter of 5 March was a consequence of FDA inspections carried out in January and February, of Novo Nordisk operations in the US in Plainsboro, fresh Jersey.
Investigators concluded that the company did not comply with the national rules governing the reporting of adverse experience after the launch of the drug (PADE) — a key safety strategy to detect post-introduction safety signals medicines to the market.
By with national law, pharmaceutical companies must immediately study all serious adverse events to the FDA within 15 days of receiving the study so that regulators can monitor emerging risks to consumers.
However, Novo Nordisk — breaking the law — decided not to study serious adverse reactions, including strokes and deaths of patients, after their staff or contractors concluded that side effects were not related to medication.
Investigators besides found that the maker did not follow any of his own interior procedures, including attempts to get safety information in serious cases of reported deaths.
In correspondence after an inspection with the agency, the company announced that it is taking "reparative and preventive action" to remove violations.
Nevertheless, the FDA sent the company a informing letter as it stated that Novo's consequence did not contain adequate details to show whether these actions would effectively solve the problems.
FDA Letter presents a number of incorrect arguments that Novo utilized to justify the deficiency of reporting of different events.
The letter described in item the case of a patient who suffered an immobilising stroke after taking liraglutide (Saxenda). The company did not study this due to the fact that it concluded that the consumer did not consider the stroke to be related to the medicine.
Otherwise, the doctor reported that the patient taking semaglutide had committed suicide. Novo decided not to investigate.
The company only reported another case of FDA suicide thoughts after agency inspectors accidentally submitted to documentation during an unreported death investigation due to a stroke.
Independent studies have linked these drugs to suicide thoughts.
Otherwise, Novo reported that it was not investigating the death of a patient utilizing semaglutide (Ozempic, Wegovy) due to the fact that the company did not get consent from the individual who reported the death. According to the FDA, consent is not required for the PADE investigation.
The FDA besides stated that even after the agency warned Novo of the violation of the law, its contractors continued to "rescind" serious adverse events. The company claimed that events were invalid due to the fact that they were missing of which patient identifiers — protected information, specified as the name or social safety number that links the individual afraid to his wellness records.
However, FDA inspectors found crucial patient identifiers in the company's interior reports' origin documents, according to the letter.
These cases of failed reports were not isolated cases. Instead, "suggest strategy errors" in the way the company receives, evaluates and reports safety data to national authorities, reported the FDA.
"On the basis of the nature of the inspection arrangements and your written answer and correspondence, we have serious concerns about the scope and impact of these violations on your full product portfolio," the FDA informed the company.
Representatives of Novo They defended the companies in a message published on their website, indicating that they were "working on a follow-up solution" contained in the letter.
"Novo Nordisk takes PADE reporting requirements seriously and we plan to deal rapidly and comprehensively with the conclusions contained in the informing letter," said Anna Windle, Head of Clinical Development, Medical and Regulatory Affairs at Novo Nordisk USA.
Adverse event reporting systems are a pillar of drug safety monitoring. If problems are not reported early and accurately, regulators may overlook early signals that the drug causes damage.
Drug safety experts have long warned that systems Post-marketing surveillance to a large extent, manufacturers study safety data accurately, which raises concerns about possible conflicts of interest.
Many medical journals call for better reporting of adverse events, especially after serious scandals specified as withdrawal of Vioxx by Merck from the marketplace after it led to tens of thousands of heart problems and deaths.
The FDA launched this week new strategy for monitoring adverse reactionsclaiming that it will improve efficiency and transparency. While any praised new strategy for monitoring adverse events, or AEMS, any critics suggested that it did not solve all the long-term problems with the systems to be replaced.
Warning letters are among the most serious tools for the enforcement of FDA law, in addition to legal action. They notify companies of serious regulatory violations and require fast corrective action to avoid further enforcement.
Novo Nordisk must respond within 15 working days with a detailed explanation of the corrective action.
If the FDA considers that the company's consequence is insufficient, the agency may take additional enforcement measures, including fines, seizure of products or court orders.
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The company faces 4,000 lawsuits in the US for life-changing side effects
Global request for Novo weight failure drugs — a class of medicines known as GLP-1 receptor agonists — has increased rapidly in fresh years, driven aggressive marketing.
Medicines, besides produced by competitor Novo, Eli Lilly, became 1 of the most profitable pharmaceutical products in the world.
GLP-1 is increasingly presented as a cure for problems beyond weight failure — from addictionby long COVIDafter Alzheimer’ s disease.
In the United States today, about 1 in 8 adults are estimated to be on GLP-1. By KFF News poll of November 2025, about 1 in 5 adults joined them.
However, the fast improvement of these medicines has besides been accompanied by expanding reports of effects, including Gastrointestinal problems, acute pancreatitis, higher indicator gallbladder and biliary disorders, kidney stones, arthritis, sleep disorders, tooth decays, malnutrition, hair loss and loss bone density and mass Musculoskeletal
These medicines may besides be associated with cancer. investigation besides shows that they may have intellectual side effects, including apathy among users.
More than 4,000 Americans sued drug producers, claiming that drugs origin side effects that change lives that companies never warned them about, stated on Thursday The Independent.
Reasons are household members of people who died abruptly after taking the medicine. Others are those who claimed that drugs caused them to make non-tissue front ischemic neuropathy (NAION) which causes failure of vision.
A survey published last week in British diary of Ophthalmology has shown that between 1 in 10,000 people are taking these medicines Naion, Ozempic users are much more susceptible to this disease than Wegova users.
In December 2024 Novo informed The Defender that she had conducted an accurate interior investigation and was not found Naion-drug relationship.
June 2025 European Medicines Agency confirmed that these medicines are associated with NAION. This condition is listed on European labelbut inactive does not happen as a side effect on U.S. Ozempic label. It simply says that patients should contact their doctor if they announcement changes in vision.
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