FDAsafety guidance72% confidence
FDA Alerts Health Care Providers to Cases of Neurologic Complications from General Anesthesia Linked to Genetic Variant in Patients of Maternal Venezuelan Ancestry
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Novartis.
Regulatory Analysis
Food and Drug Administration (FDA) is investigating the safety of sevoflurane and other general anesthetics based on published scientific reports of unexpected catastrophic outcomes, including severe neurologic adverse outcomes and death, occurring in adult and pediatric patients.
Supporting Context
- Therapeutic area
- Nephrology · IgA Nephropathy
- Sub-indication
- Ild
Related signal: Novartis initiates Phase III trial of Atrasentan in pediatric IgAN patients