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FDA warns on anesthesia and sedation in pregnant women, young children

The US Food and Drug Administration (FDA) is requiring that labels of general anesthetic and sedation drugs contain a new warning about their use in pregnant women during the 3rd trimester, and in children younger than 3 years. The action reflects concern about the effect that these agents may have on development of a child’s brain.

The FDA has been investigating the potential adverse effects of general anesthetic and sedation drugs on development of children’s brains since the first animal study on the topic in 1999. Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.

The agency is recommending that physicians balance the benefits of appropriate anesthesia against the potential risks in pregnant women and children, particularly for procedures that may last more than 3 hours or if multiple procedures are required in children younger than 3 years.

The drugs affected by the label change are deslurane, etomidate, halothane, isoflurane, ketamine, lorazepam injection, methohexital, midazolam injection and syrup, pentobarbital, propofol, and sevoflurane.


FDA drug safety communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women.