Novo Nordisk gets FDA warning letter for adverse event reporting violations
The US Food and Drug Administration (FDA) sent a warning letter on 10 March to Novo Nordisk at its Plainsboro, NJ, site for a raft of postmarketing adverse drug experience (PADE) violations, including failing to report adverse events for patients taking the company’s GLP-1 treatments indicated for diabetes and weight management.The letter refers to an inspection carried out at the facility from 13 January—7 February 2025. This inspection was part of the FDA's Bioresearch Monitoring Program (BIMO), which aims to ensure that accurate, reliable, and timely safety data are submitted to the FDA for monitoring product safety and to ensure compliance with PADE regulations.
FDA said the company failed to develop written procedures that ensured all adverse drug experiences (ADEs) that are the subject of 15-day alert reports were promptly investigated in accordance with 21 CFR 314.80(c)(1)(ii), in accordance with PADE regulations.
For example, the warning letter states that Novo Nordisk failed to follow the procedure for reporting adverse events, citing three deaths (one by suicide) that were reported in patients taking semaglutide, the active ingredient in Ozempic and Wegovy. However, the agency did not tie the deaths to the use of the drug.
“For example, Argus Case #1342548 includes a consumer reporting a death for a male patient who received semaglutide; however, you invalidated the case because you failed to capture the patient identifier. During the inspection, FDA found the patient identifier in the source documents for this case. As a result of this erroneous invalidation, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required,” the warning letter states.
Another case, Argus Case #1171264, “includes a non-health care professional reporting the death of a patient receiving semaglutide; however, 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 company also “failed to promptly investigate Argus Case #1079792, in which a physician reported to your company representative that a patient taking semaglutide was depressed and committed suicide. You failed to document any attempt to obtain additional information from the reporter, including patient identifiers. As of the date of issuance of this letter, this case has not been submitted to FDA.”
FDA also said the company failed to develop written procedures for the surveillance, receipt, evaluation, and reporting of PADEs for several drugs, as required by 21 CFR 314.80(b). FDA stated in the letter that the company failed to develop written procedures, as required by regulation, that “ensured that you, and your contractor acting on your behalf, reported all serious and unexpected ADEs to FDA within 15 calendar days.”
“Based on your written procedure, your staff or contractor cancelled or rejected serious and unexpected ADEs that were required to be reported within 15 calendar days because they documented these events as being unrelated to the product,” the letter states.
“For example, Argus Case #1331385 involves a consumer who was disabled after experiencing a stroke, which is a serious and unexpected ADE, while receiving liraglutide. The consumer reported that the stroke was not related to liraglutide; therefore, you rejected this case. As a result, you failed to report serious and unexpected ADEs to FDA within 15 calendar days, as required by PADE regulations.”
FDA noted that the company has taken corrective and preventive action to address these deficiencies, but called the response “inadequate.”
“FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product’s safety profile and uphold FDA’s mission to protect and promote public health. Reporting ADEs to FDA within the required time frames is necessary for the ongoing monitoring of drug safety profiles. Failure to report and investigate ADEs may limit the safety information that FDA may need when monitoring potential safety signals,” according to the warning letter.
The FDA gave the company 15 business days to respond to the actions it has taken to address these problems noted in the warning letter.
Novo Nordisk said that it is working to resolve these observations, which were also flagged in a Form FDA 483 report issued on 7 February.
“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” Anna Windle, Head of Clinical Development, Medical and Regulatory Affairs, Novo Nordisk US, said in a statement dated 10 March. “We are confident that we will resolve the matters outlined in Warning Letter to the FDA’s full satisfaction.”
Warning letter
