FDA Issues New Warnings for Use of General Anesthetic and Sedation Drugs in Young Children and Pregnant Women

PUBLISHED: Dec 14, 2016
Source: Food and Drug Administration

The US Food and Drug Administration (FDA) has issued a Drug Safety Communication 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 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 early life anesthetic exposure affects children’s brain development.

To better inform the public about this potential risk, the FDA is requiring warnings to be added to the labels of general anesthetic and sedation drugs (see Drug Safety Communication, link below, for the List of General Anesthetic and Sedation Drugs Affected by this Label Change.) The FDA will continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available.

Background:

The 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. FDA held advisory committee meetings in 2007, 2011, and 2014. To 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). More research is still needed to provide additional information about the safe use of these drugs in young children and pregnant women.

Recommendations for Health Care Professionals:

  • 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 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 requiring anesthetic and sedation drugs.
  • No specific anesthetic or sedation drug has been shown to be safer than any other.
  • Based on comparisons across species, the window of vulnerability to these changes in the brain is believed to correlate with exposures in the third trimester of pregnancy through the first year of life, but may extend out to approximately 3 years in humans. The clinical significance of these nonclinical findings is not clear.
  • Some published studies suggest that similar deficits in cognition and behavior may occur in children, particularly after repeated or prolonged exposures to anesthetic drugs early in life. These studies have limitations, and it is not clear if the effects reported are due to the anesthetic/sedation drugs, or to other factors such as the surgery or underlying illness.
  • Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the risks.
  • Discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing and duration of surgery or procedures requiring anesthetic and sedation drugs. Also discuss with them the health risks of not treating certain conditions.
  • Report adverse events involving anesthetic or sedation drugs to the FDA MedWatch program

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