FDA probes anesthesia-linked neurological complications in some patients of Venezuelan ancestry

The U.S. Food and Drug Administration (FDA) is investigating the safety of sevoflurane and other general anesthetics following reports of severe neurological complications and deaths in patients of maternal Venezuelan ancestry after routine anesthesia.

According to the FDA, published scientific studies have linked cases involving both adult and pediatric patients to exposure to sevoflurane, a commonly used inhaled anesthetic. The reported cases may also involve a rare mitochondrial genetic variant.

The agency identified the genetic variant, known as MT-ND4 m.11232T>C, in a subset of patients who experienced serious adverse events after receiving sevoflurane. Although the reported cases have been associated with sevoflurane, the FDA said the genetic finding raises concerns about the safety of all volatile anesthetics.

The FDA issued the safety alert following recent earthquakes in Venezuela to help ensure that healthcare providers traveling to the country, as well as organizations providing medical assistance to Venezuelans, are aware of the rare but serious risk.

Pending further investigation, the FDA advised healthcare providers working in Venezuela to consider alternatives to volatile anesthetics, such as intravenous anesthetics or regional anesthesia, when clinically appropriate and available.

The agency said it is continuing to evaluate the emerging safety concern to determine its potential implications for the U.S. population and FDA-approved anesthetic products. -Reporting by Puyaan Singh in Bengaluru; Editing by Maju Samuel/Reuters