A “warning letter” from the US FDA to Novo Nordisk has alleged that the Danish pharmaceutical company failed to report adverse drug reactions linked to its glucagon-like peptide 1 (GLP-1) products.
Sent to Novo Nordisk earlier this month, the letter highlighted that “objectionable conditions [were] observed” during an inspection of its New Jersey facility in January and February last year.
According to the FDA, the inspection revealed “serious violations” of “reporting requirements”, finding that adverse drug experiences reported to the company were allowed to be “rejected or cancelled” if they were considered to be “unrelated to the product”.
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This is “inconsistent with FDA regulations” which state that any adverse reactions “determined to be serious or unexpected” must be reported to the agency within 15 days, the letter said.
The regulator referred to one case where a patient “was disabled after experiencing a stroke” while receiving liraglutide, and found that the event was not reported by Novo Nordisk as the stroke was “not related” to the medication.
It added that in another case, a “non-healthcare professional” reported the death of “a patient receiving semaglutide”, but Novo Nordisk “failed to promptly investigate” this as “consent was not obtained from the reporter” and it consequently was not reported to the FDA.
“Systemic failures”
A third example noted that a physician reported to a Novo Nordisk “company representative” that a patient taking semaglutide “was depressed” and had died by suicide.
But the pharmaceutical company “failed to document any attempt to obtain additional information from the reporter” - and at the time of the FDA’s letter, the case still had not been submitted to the regulator, it said.
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The FDA letter did acknowledge the “corrective and preventive actions” Novo Nordisk has taken since the inspection, but it stressed that the drugmaker’s response was “inadequate” because it “did not provide sufficient details” to determine whether these actions “effectively resolved the existing issues and will prevent similar violations in the future”.
The company’s explanations “suggest systemic failures with [Novo Nordisk’s] surveillance, receipt, evaluation, and reporting of adverse drug experiences” to the FDA, the letter said.
And it noted that these findings raised “significant concerns” about the company’s ability to “accurately and completely report product safety information”.
“Action plan”
In a company statement published last week, Novo Nordisk said that it had been “working diligently” to “address” and “resolve” the FDA’s observations through a “corrective and preventative action plan”, keeping the FDA “informed on its progress”.
“The warning letter largely seeks additional details on these measures to confirm current and future regulatory compliance; it does not make any conclusions about the quality or safety of our medicines,” it said.
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Novo Nordisk head of clinical development, medical and regulatory affairs Anna Windle said that the company takes adverse drug experience reporting requirements “seriously” and that it plans to “address the requests...expeditiously and holistically”.
“We are confident that we will resolve the matters outlined in the warning letter to the FDA’s full satisfaction,” she added.
It comes after the UK drugs regulator revealed that the deaths of two people in Northern Ireland were reported between 2024 and 2025 over a potential link to weight loss jabs.
