The Food and Drug Administration (FDA) is requiring new warnings to be added to the labels of general anesthesia and sedation drugs that repeated or lengthy use of the medications during surgeries or procedures in children younger than 3 years or pregnant women during their third trimester may affect the development of children’s brains.
Recent human studies were consistent with previous animal studies that suggest a single, relatively short exposure to general anesthesia and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. The agency said more research is needed to fully characterize how early life anesthetic exposure affects the development of children’s brains. The new warnings required by the FDA are designed to inform the public of this risk.
“Anesthetic and sedation drugs are necessary for infants, children and pregnant women who require surgery or other painful and stressful procedures, especially when they face life-threatening conditions requiring surgery that should not be delayed,” the FDA said. “In addition, untreated pain can be harmful to children and their developing nervous systems.
This isn’t the first time the FDA has cautioned the public about potential adverse effects of general anesthetic and sedation drugs in young children and pregnant women. In 1999, when the first animal study was published on the topic, the FDA began investigating the link. In 2007, 2011, and 2014, the agency held advisory committee meetings on the topic. The agency also formed a partnership with the International Anesthesia Research Society called SmartTots (Strategies for Mitigating Anesthesia-Related neurotoxicity in Tots).
Medications affected by the label updates include desflurane (Suprane), etomidate (Amidate), halothane, isoflurane (Forane), ketamine (Ketalar), lorazepam injection (Ativan), methohexital (Brevital), midazolam injection syrup, pentobarbital (Nembutal), propofol (Diprivan), and sevoflurane (Ultane, Sojurn).
The FDA recommends that parents and caregivers discuss with their child’s health care professional the potential adverse effects of anesthesia on brain development as well as appropriate timing of procedures that can be delayed without jeopardizing their child’s health. Pregnant women should have similar conversations with their health care provider, the FDA said.
Any adverse events related to these medications should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Safety Communication