The FDA sent Novo Nordisk a warning over unreported weight loss drug side effects

The Food and Drug Administration issued a warning letter to Novo Nordisk earlier this month, citing the company’s failure to report serious suspected side effects from its drugs to the agency within required deadlines.

The letter followed an inspection of a Novo Nordisk facility conducted between Jan. 13 and Feb. 7, 2025, the FDA said. The agency found that the company failed to submit reports of serious and unexpected adverse drug experiences within the required 15-day window and failed to adequately investigate those reports.

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Among the specific cases the FDA identified: a patient who was disabled after experiencing a stroke while taking liraglutide; a patient death involving a male who had received semaglutide, where Novo Nordisk failed to capture a patient identifier and did not submit the report; and a consumer who reported suicidal ideation while taking semaglutide, a case that sat in “medical review” status for nearly two months before being submitted to the FDA. The FDA did not conclude whether any of the deaths were linked to the drugs, according to The Wall Street Journal.

A second death — a patient taking semaglutide whose physician reported depression and suicide — had not been submitted to the FDA as of the date the warning letter was issued, the agency said.

Semaglutide is the active ingredient in Novo Nordisk’s blockbuster weight loss drugs Ozempic and Wegovy.

The FDA said Novo Nordisk’s written procedures allowed adverse event reports to be rejected if a reporter believed the event was unrelated to the product — a standard inconsistent with federal regulations, which require reporting of any adverse event associated with a drug’s use in humans regardless of perceived causation. The agency also found that cases were improperly invalidated due to missing patient identifiers even when those identifiers were present in source documents.

“Your explanations, when taken into consideration with the violations described above and your failure to adequately address your noncompliance, suggest systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA,” the agency wrote.

The FDA acknowledged corrective steps Novo Nordisk has taken since the inspection but said the company’s responses lacked sufficient detail to confirm that future violations would be prevented. Novo Nordisk has 15 business days to inform the agency of actions it will take. Failure to respond adequately may lead to regulatory action, the FDA said.

Novo Nordisk said it has been in regular communication with the FDA about its corrective action plan and is working to respond to the letter. “We are confident that we will be able to respond to the requests in the Warning Letter to the Agency’s full satisfaction,” the company said, according to The Wall Street Journal. The company added that the letter does not reach conclusions about the quality or safety of its treatments.

The warning covers products with active ingredients including semaglutide, liraglutide, nedosiran sodium, and estradiol, according to the FDA.

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