July 2 (Reuters) – The U.S. Food and Drug Administration said on Thursday it is investigating the safety of sevoflurane and other general anesthetics after reports of severe neurologic complications and deaths in patients of maternal Venezuelan ancestry following routine anesthesia.
The agency said cases involving both adult and pediatric patients have been connected, according to published scientific studies, to exposure to sevoflurane, a commonly used inhaled anesthetic. These cases may also involve a rare mitochondrial genetic variant.
Here are further details:
• The FDA said the rare mitochondrial genetic variant, known as MT-ND4 m.11232T>C, has been reported in a subset of patients who experienced serious adverse events after exposure to sevoflurane.
• Although the currently reported cases have been linked to sevoflurane, the FDA said the genetic variant raises concerns about all volatile anesthetics.
• The agency said it issued the alert in light of recent earthquakes in Venezuela, to ensure healthcare providers traveling to the country and groups providing medical resources to Venezuelans are aware of the rare but serious events.
• Until more information is available, the FDA said providers working in Venezuela may consider alternatives to volatile anesthetics such as intravenous anesthetics or regional anesthesia, where clinically appropriate and available.
• The FDA said it continues to review the emerging safety concern for potential implications for the U.S. population and FDA-approved anesthetic products.
(Reporting by Puyaan Singh in Bengaluru; Editing by Maju Samuel)
