Novo Nordisk's stock price drops due to FDA warning letter

Investing.com – Novo Nordisk (NYSE:NVO) stock fell 2.8% on Tuesday after the company received a warning letter from the U.S. Food and Drug Administration (FDA) stating that it violated post-market adverse event reporting requirements.

The FDA issued the warning letter on March 5, 2026, following an inspection of Novo Nordisk conducted from January 13 to February 7, 2025. The inspection found serious violations related to adverse drug reaction reports for products including semaglutide, liraglutide, nedosiran sodium, and estradiol.

The FDA accused the company of failing to establish adequate written procedures to monitor, receive, evaluate, and report post-market adverse drug reactions. The FDA found that Novo Nordisk and its contractors failed to report serious and unexpected adverse events within the required 15-day timeframe.

According to the warning letter, the company’s written procedures allowed reports to be rejected or canceled if the reporter believed the adverse event was unrelated to the product, which is inconsistent with FDA regulations. The FDA identified multiple cases, including strokes, deaths, and suicidal ideation, where serious adverse events were not reported within the required timeframe or were invalidated despite having valid patient identification information.

The FDA also found that Novo Nordisk failed to promptly investigate adverse events requiring 15-day alert reports, partly due to unnecessarily requiring reporter consent before conducting follow-up.

Between March 2025 and January 2026, Novo Nordisk submitted multiple responses to the FDA, describing corrective actions such as revising procedures, conducting retrospective case reviews, and transferring safety case intake to dedicated internal patient safety personnel. However, the FDA considered these responses insufficient, stating that the company did not provide enough details to determine whether these measures could prevent similar violations in the future.

The FDA has requested the company to respond within 15 business days, explaining the measures taken to prevent similar violations.

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