The FDA recently sent a warning letter to Novo Nordisk, raising concerns about the drug company failing to report adverse drug events.
The letter, dated March 5, outlines the FDA’s observations at the drug company’s site in Plainsboro, N.J., during an inspection in early 2025.
The post-marketing adverse drug experience inspection found a written procedure that “allowed adverse drug experiences reported to Novo Nordisk to be rejected or cancelled (and therefore not to be reported to the FDA),” according to the letter.
In one case, there was a patient “who was disabled after experiencing a stroke, which is a serious and unexpected [adverse drug event], while receiving liraglutide,” the letter said. “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 [adverse drug events] to FDA within 15 calendar days,” as required by federal regulations.
In a March 10 online statement, Novo Nordisk said it has been working to resolve the matters raised by FDA inspectors since early 2025, adding it has regularly provided updates to the FDA on corrective actions.
“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,” the drugmaker said.
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