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Regulatory Focus™ > News Articles > New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women

New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women

Posted 14 December 2016 | By Zachary Brennan 

New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women

The U.S. Food and Drug Administration (FDA) on Wednesday warned that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect the development of children’s brains.

The warning comes as FDA says 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. However, further research is needed to fully characterize how anesthetic exposure affects children’s brain development.

“Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain. Studies in young animals suggest these changes result in long-term effects on the animals’ behavior or learning,” FDA said. “Studies have also been conducted in children, some of which support findings from previous animal studies, particularly after repeated or prolonged exposure to these drugs early in life. All the studies in children had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.”

New Warnings

To better inform the public about this potential risk, FDA has added warnings to the labels of 11 general anesthetic and sedation drugs, including Diprivan (propofol) and halothane. FDA notes that the list includes anesthetic and sedation drugs that block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity but no specific medications have been shown to be safer than any other.

“We will continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available,” the agency said.
FDA has been investigating the potential adverse effects of general anesthetic and sedation drugs on children’s brain development since the first animal study on this topic was published in 1999. The agency also held advisory committee meetings in 20072011, and 2014.

To better coordinate and fund research in this area, FDA also formed a partnership with the International Anesthesia Research Society (IARS) called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots).

“I would like to thank them and the stakeholders and medical experts in anesthesiology, pediatrics, neuroscience and epidemiology who are working to make surgery safer for the millions of infants and young children who undergo anesthesia or sedation each year,” Janet Woodock, director of FDA’s Center for Drug Evaluation and Research, said in a statement. 

Safety Announcement

FDA Statement from Woodcock on new safety information on anesthesia use in young children and pregnant women

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