March 23, 2026 at 8:53 am

FDA Warns Novo Nordisk Over Incomplete Reporting of GLP-1 Drug Side Effects

The U.S. FDA has issued a warning letter to Novo Nordisk citing incomplete reporting of postmarketing adverse events associated with semaglutide (Ozempic, Wegovy), including serious outcomes such as deaths and a suicide.

While causation has not been established, incomplete reporting can delay recognition of potential medication-induced harms. MISSD previously highlighted emerging reports of psychiatric effects associated with GLP-1 medications, including akathisia, anxiety, and medication-induced suicidality:
https://missd.co/a-popular-weight-loss-drug-is-being-associated-with-medication-induced-suicidality

What to monitor:

  • Sudden inner restlessness or agitation
  • New or worsening anxiety or depression
  • Suicidal thoughts or behavioral changes

Recommended actions:

  • Contact your prescriber if symptoms arise
  • Report adverse events to FDA MedWatch
  • Use a trusted support person when starting or changing medications

MISSD supports informed decision-making, transparency, and education to improve patient safety. Take our free courses and see our educational resources available via the “Resources” link at the top of our website.