FDA warns on repeated, lengthy use of general anesthesia drugs
January 12, 2017
The U.S. Food and Drug Administration issued a warning in December 2016 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.
The FDA is requiring warnings to be added to the labels of general anesthetic and sedation drugs. The agency will also continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available, according to an FDA news release.
Anesthetic and sedation drugs are necessary for infants, children and pregnant women who require surgery or other painful and stressful procedures, helping to ensure the health, safety and comfort of patients, the FDA said. Studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs is unlikely to have negative effects on behavior or learning, according to the FDA. However, further research is needed to fully characterize how early life anesthetic exposure affects children's brain development.
The list distributed by the FDA includes anesthetic and sedation drugs that block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity. These drugs are usually injected into a vein or inhaled through a mask.
The FDA said in a news release that health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last longer than three hours or if multiple procedures are required in children under 3 years old. Health care professionals should also discuss with parents, caregivers and pregnant women the benefits, risks and appropriate time of surgery or procedures requiring anesthetic and sedation drugs.
The ADA House of Delegates voted at its October 2016 meeting to adopt revisions to the guidelines concerning the use of sedation and anesthesia by dentists and teaching sedation and anesthesia to dentists and dental students. However, when it comes to the children, the ADA refers to guidelines set by the American Academy of Pediatrics and the American Academy of Pediatric Dentistry. To read those guidelines, visit aapd.org
. State laws for dentist providers of moderate and deep sedation/general anesthesia may be accessed from state dental board websites.