FDA Probes Sevoflurane-Linked Neurological Complications in Patients of Venezuelan Ancestry
Key Insights
The FDA is investigating severe neurologic complications and deaths linked to sevoflurane and other volatile anesthetics in patients of maternal Venezuelan ancestry following routine anesthesia.
Cases involve both adult and pediatric patients and may be associated with a rare mitochondrial genetic variant, MT-ND4 m.11232T>C (search).
The agency issued the alert following recent earthquakes in Venezuela to inform healthcare providers traveling to the region about these rare but serious events.
The U.S. Food and Drug Administration announced on Thursday that it is investigating the safety of sevoflurane and other general anesthetics following reports of severe neurologic complications and deaths in patients of maternal Venezuelan ancestry after routine anesthesia. The agency confirmed that cases involving both adult and pediatric patients have been connected, according to published scientific studies, to exposure to sevoflurane, a commonly used inhaled anesthetic.
The FDA indicated that these adverse events may involve a rare mitochondrial genetic variant, identified as MT-ND4 m.11232T>C (search), which has been reported in a subset of patients who experienced serious complications after sevoflurane exposure.
Scope of the Safety Concern
Although the currently reported cases have been specifically linked to sevoflurane, the FDA cautioned that the genetic variant raises broader concerns about all volatile anesthetics. The agency emphasized that the investigation remains ongoing and that it continues to review the emerging safety signal for potential implications for the U.S. population and FDA-approved anesthetic products.
Guidance for Healthcare Providers
The FDA issued the alert in light of recent earthquakes in Venezuela, aiming to ensure that healthcare providers traveling to the country and groups providing medical resources to Venezuelans are aware of these rare but serious events. Until more information becomes available, the agency recommended that providers working in Venezuela may consider alternatives to volatile anesthetics—such as intravenous anesthetics or regional anesthesia—where clinically appropriate and available.
The investigation underscores the importance of pharmacogenetic considerations in anesthetic management and highlights how mitochondrial genetic variants may influence drug safety in specific patient populations.