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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA Alerts Health Care Providers to Cases of Neurologic Complications from General Anesthesia Linked to Genetic Variant in Patients of Maternal Venezuelan Ancestry
The U.S. 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 of maternal Venezuelan ancestry following routine general anesthesia with sevoflurane. In light of the recent earthquakes in Venezuela, FDA wants to ensure that agencies or groups providing medical resources to Venezuelans and health care providers traveling to the country are aware of these rare but serious events.
A rare mitochondrial genetic variant (MT-ND4 m.11232T>C) has been reported in a subset of patients who experienced serious adverse events following exposure to sevoflurane. Although the currently reported cases have been linked to sevoflurane, this genetic variant raises concerns regarding all volatile anesthetics. FDA is continuing to review this emerging safety concern for implications for the U.S. population and FDA-approved anesthetic products. Until more information is available, agencies or groups providing medical resources to Venezuelans and health care providers working in Venezuela may consider using alternatives to volatile anesthetics, such as intravenous anesthetics or regional anesthesia, where clinically appropriate and available.
Health care providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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