December 14, 2016

FDA: Repeated, Lengthy Use of Anaesthetics May Affect Brain Development in Children

ROCKVILLE, Md -- December 14, 2016 -- The US Food and Drug Administration (FDA) is warning that repeated or lengthy use of general anaesthetic and sedation drugs during surgeries or procedures in children aged 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 anaesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behaviour or learning. However, further research is needed to fully characterize how early life anaesthetic 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 anaesthetic and sedation drugs, including desflurane (Suprane); etomidate (Amidate); halothane; isoflurane (Forane); ketamine (Ketalar); lorazepam injection (Ativan); methohexital (Brevital); midazolam injection, syrup; pentobarbital (Nembutal); propofol (Diprivan); sevoflurane (Ultane, Sojourn).

The FDA has been investigating the potential adverse effects of general anaesthetic and sedation drugs on children’s brain development since the first animal study on this topic was published in 1999. The FDA held advisory committee meetings in 2007, 2011, and 2014. To coordinate and fund research in this area, the 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.

Information for healthcare providers:
• No specific anaesthetic 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 behaviour may occur in children, particularly after repeated or prolonged exposures to anaesthetic drugs early in life. These studies have limitations, and it is not clear if the effects reported are due to the anaesthetic/sedation drugs, or to other factors such as the surgery or underlying illness.
• Decisions regarding the timing of any elective procedures requiring anaesthesia 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 anaesthetic and sedation drugs. Also discuss with them the health risks of not treating certain conditions.

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.

The FDA urges patients and healthcare professionals to report side effects involving anaesthetic or sedation drugs to the FDA MedWatch program by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

SOURCE: US Food and Drug Administration

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