FDA Indicates Reports of Ozempic Problems, Deaths Not Adequately Reported by Novo Nordisk

Inspectors say the company failed to report certain incidents it unilaterally determined were not the result of Ozempic side effects, but the FDA says federal regulations do not allow manufacturers to make that decision.

Federal investigators say an inspection of Novo Nordisk facilities uncovered unreported incidents involving deaths and other problems on Ozempic, raising concerns about regulatory violations and potential underreporting of the drug’s side effects.

An inspection conducted earlier this year prompted the U.S. Food and Drug Administration (FDA) to send Novo Nordisk a warning letter on March 5, stating that the company committed serious violations of postmarketing adverse drug experience (PADE) reporting requirements.

Ozempic (semaglutide) was first approved by the FDA in 2017, as a Type 2 diabetes treatment. It is part of a new class of medications known as GLP-1 drugs, which have been widely prescribed due to the significant weight loss benefits. To capitalize on the popularity of Ozempic for weight loss, Novo Nordisk introduced a higher-dose version called Wegovy, which was specifically approved for use as a diet drug.

Over the past year, both Ozempic and Wegovy, as well as their competitors, Eli Lilly’s Mounjaro and Zepbound, have become popular blockbuster drugs, which have been used by millions of individuals.

However, as more and more people use the medications, there have been increasing concerns about serious side effects that were not initially disclosed on the drug labels, including stomach paralysis, intestinal obstructions, vision loss and other problems. These issues have led to a growing number of Ozempic stomach paralysis lawsuits and Ozempic vision loss lawsuits filed nationwide over the last year. Each complaint involves similar allegations that Novo Nordisk failed to properly warn consumers about the potential health risks.

Now, FDA inspectors are saying Novo Nordisk also deceived the agency about the safety of semaglutide by failing to disclose certain adverse event incidents it received from users and the medical community.

Federal investigators reviewed Novo Nordisk’s operations between January 13 and February 7, 2025, as part of the FDA’s Bioresearch Monitoring Program, which is intended to ensure that drug manufacturers collect and report accurate, reliable and timely safety data.

According to the warning letter, inspectors found that Novo Nordisk failed to establish adequate written procedures for evaluating and reporting postmarketing adverse drug experiences. The agency determined that the company’s internal policies did not comply with federal reporting requirements.

Investigators also found that Novo Nordisk failed to report certain serious and unexpected adverse events to the FDA within the required 15-day timeframe. In several cases, the company chose not to report incidents it believed were not causally related to the drug, even though the FDA states federal law does not allow manufacturers to make that determination when deciding whether an event must be reported.

“FDA’s regulations require applicants to develop written procedures for, among other things, the reporting of ADEs regardless of whether the event is considered causally related to the product. An ADE that is determined to be both serious and unexpected must be reported to FDA no later than 15 days from the date of initial receipt.”

– FDA Warning Letter to Novo Nordisk

After the investigation, FDA inspectors talked to company officials about how to address the deficiencies, but they wrote in the letter that the company failed to sufficiently explain how they were updating procedures, guidance and training manuals to fall in line with federal regulations.

Among the agency’s findings, inspectors found records of three deaths by Ozempic or Wegovy users that were not reported to the FDA in a timely fashion, including one who died by suicide. While the agency did not directly blame the drugs for the patients’ deaths, the letter warns that it was inappropriate for Novo Nordisk to make that decision on its own.

The report indicates Novo Nordisk officials told FDA inspectors that they failed to turn in some reports due to a lack of patient identifiers. However, the inspectors were able to find those identifiers in the company’s own records.

The letter demands that Novo Nordisk respond within 15 days of its receipt and notify the FDA of the actions the company will take to prevent future violations. Failure could result in additional regulatory actions, the agency warns.

Ozempic Stomach Paralysis Lawsuits

The most common serious side effects of Ozempic and Wegovy appear to be linked to gastrointestinal issues, like gastroparesis, which is a form of stomach paralysis. Claims alleging GLP-1 drug makers failed to warn about Ozempic stomach paralysis risks sparked the first wave of litigation against both Novo Nordisk and Eli Lilly.

Similar to the FDA letter, plaintiffs say the manufacturers did not adequately disclose the risks that the drugs could severely slow gastric emptying, which could lead to serious health consequences.

More than 3,300 GLP-1 stomach paralysis lawsuits have been consolidated into a multidistrict litigation (MDL) in the Eastern District of Pennsylvania before U.S. District Judge Karen Marston for coordinated discovery and pretrial proceedings.

Judge Marston has indicated the court will work with the parties to select a small group of representative cases for bellwether trials, allowing both sides to gauge how juries may respond to evidence and testimony likely to recur across thousands of similar claims.

GLP-1 NAION Vision Loss Lawsuits

Judge Marston has also been selected to oversee a growing number of GLP-1 vision loss lawsuits that claim the medications, particularly Ozempic and Wegovy, are linked to an increased risk of rapid onset vision loss known as non-arteritic anterior ischemic optic neuropathy (NAION). This condition can cause blurred vision, reduced vision and blindness, which may be permanent.

She is expected to organize similar early test trials for the GLP-1 vision loss litigation, though those cases are at a much earlier stage than claims involving stomach paralysis.

Although the outcomes of these trials will not be binding on other claims, they will be closely watched to see what kinds of payouts juries award to plaintiffs, which are likely to have a significant impact on negotiations. However, if no settlement is reached following the bellwether trials, Judge Marston is likely to remand the cases back to their originating districts for individual trial dates.

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