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.