Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information.
On December 14, 2016, FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to these drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. However, further research is needed to fully characterize how early life anesthetic exposure affects children’s brain development.
We are requiring warnings be added to the labels of these drugs. We will continue to monitor and will update the public if additional information becomes available.
Anesthetic and sedation drugs are necessary for those who require surgery or other painful and stressful procedures. Additionally, untreated pain can be harmful to children and their developing nervous systems.
Health care professionals should balance the benefits of appropriate anesthesia against the potential risks, especially for procedures lasting longer than 3 hours or if multiple procedures are required in children under 3 years. Discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures.
Studies in pregnant and young animals have shown that using these drugs for more than 3 hours caused widespread loss of brain nerve cells. Studies in young animals suggest this results in long-term effects on the animals’ behavior or learning. Some studies in children support the animal studies’ findings, particularly after repeated or prolonged exposure early in life. All studies in children had limitations. It is unclear whether effects seen were due to the drugs or other factors.
FDA has been investigating this issue since the first animal study published in 1999. We held multiple advisory committee meetings and formed a partnership called SmartTots with the International Anesthesia Research Society. More research is needed on the safe use of these drugs in young children and pregnant women.