FDAsafety guidance84% 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: illustrates how regulators handled a comparable safety guidance decision relevant to Medline; the same agency is already in play for this signal, so precedent weight is higher.
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
- Infection Control · Medical Devices
- Sub-indication
- General
Related signal: FDA Alerts on Non-Sterile BD ChloraPrep Applicators in Medline Convenience Kits