What did the FDA warn Novo Nordisk about regarding Ozempic?

The FDA issued a warning letter to Novo Nordisk for failing to report all suspected side effects in patients who took its drug Ozempic.

What kind of side effects were not reported for Ozempic?

Among the unhe reported cases were two deaths and a suicide, though the FDA did not stipulate whether these were linked to the drug.

How many Ozempic-related reports were not properly submitted to the FDA?

FDA investigators found over 300 reports that had not been sent to the agency, with some being more than 1,000 days late.

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FDA Warns Novo Nordisk Over Ozempic Side Effect Reporting

11 Mar

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Summary

FDA issued a warning letter to Novo Nordisk regarding Ozempic.
Company failed to report all suspected patient side effects.
More than 300 reports were significantly delayed or missing.

FDA Warns Novo Nordisk Over Ozempic Side Effect Reporting

Novo Nordisk A/S has been issued a warning letter by the US Food and Drug Administration (FDA) due to concerns over the reporting of suspected side effects associated with its widely used diabetes medication, Ozempic. The FDA's March 5 letter highlighted instances where not all adverse events, including two deaths and a suicide, were appropriately reported.

The regulatory agency's inspection, conducted early last year, revealed over 300 reports that had not been submitted to the FDA, with some delays exceeding 1,000 days. Novo Nordisk acknowledged these reporting failures, which date back to 2020, and stated its commitment to address the FDA's concerns comprehensively and expeditiously.