Packaging for the Ozempic injectable pen
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NEED TO KNOW
The FDA sent a “warning letter” to pharmaceutical giant Novo Nordisk, manufacturer of GLP-1 medications like Ozempic and Wegovy
The agency claims the company failed to report potential serious side effects and deaths from users that were taking its GLP-1 medications within the required timeframe. The FDA did not speculate as to whether the deaths or other side effects were necessarily linked to the medication.
Novo Nordisk says it is working to address the violations
Novo Nordisk — the pharmaceutical giant behind GLP-1 medications like Ozempic and Wegovy — has received a warning letter from the U.S. Food and Drug Administration for “serious violations” of agency’s policies on reporting potential side effects and deaths.
In a letter dated March 5, the FDA says that Novo Nordisk, “failed to report serious and unexpected [adverse drug experiences] ADEs to FDA within 15 calendar days, as required,” and failed to report three deaths.
The agency wrote that it discovered the violations during a Postmarketing Adverse Drug Experience, or PADE, inspection that was conducted between January 13 and February 7, 2025 at the company’s Plainsboro, N.J., facility. These inspections are “designed to ensure that accurate, reliable, and timely safety data are submitted to FDA for the monitoring of product safety, and to ensure compliance with PADE regulations.”
Wegovy injectable pens
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However, the FDA says that Novo Nordisk neither submitted adverse reactions within 15 calendar days, nor performed required followups with the patients.
The FDA noted that Novo Nordisk received a report of a patient on the GLP-1 semaglutide, who died by suicide. But, “you failed to promptly investigate because consent was not obtained from the reporter and the reporter was a non-health care professional, as stated in your written procedure. This case was closed without your reporting it to FDA,” the agency wrote.
Another person “who was disabled after experiencing a stroke, which is a serious and unexpected ADE, while receiving [the GLP-1 medication] liraglutide” was not reported to the FDA within 15 calendar days, the agency said, because the “consumer reported that the stroke was not related to liraglutide; therefore, you rejected this case.”
In a statement on its website, the pharmaceutical company said they have “been working diligently to address those observations ever since.”
“Since the inspection in early 2025, Novo Nordisk has been working to resolve the observations in the Form FDA 483 through its corrective and preventative action plan, and has kept the FDA informed on its progress, including through an initial response and seven updates.”
However, the FDA addressed this in their letter, writing, “While we acknowledge the corrective and preventive actions your firm has taken since our inspection, your response is inadequate because you did not provide sufficient details to determine whether your actions will effectively prevent similar violations in the future.”
Novo Nordisk’s headquarters in in Bagsvaerd, near Copenhagen, Denmark
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Anna Windle, Head of Clinical Development, Medical and Regulatory Affairs, Novo Nordisk U.S., said in the statement, “Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically … We are confident that we will resolve the matters outlined in Warning Letter to the FDA’s full satisfaction.”
In a statement to PEOPLE, a representative for Novo Nordisk said, “As noted in the Company Statement, we initially responded to the Form FDA 483 within the Agency’s deadline, on March 3, 2025, and has shared seven updates with the Agency since then. Over the past year, Novo Nordisk has undertaken a broad, multi‑pronged effort to address the FDA PADE inspection – closing potential gaps while building durable and scalable pharmacovigilance capability. We are confident that we will be able to respond to the requests in the Warning Letter to the Agency’s full satisfaction.”
“In line with our commitment to patient safety, Novo Nordisk will respond to the Warning Letter and seek to engage in dialogue with the FDA to ensure the Warning Letter is resolved expeditiously and to the Agency’s full satisfaction.”
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