General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women
AUDIENCE: Consumer, Surgery, Anesthesiology
ISSUE: 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 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, FDA is requiring warnings to be added to the labels of general anesthetic and sedation drugs (see List of General Anesthetic and Sedation Drugs Affected by this Label Change). 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.
See the FDA Drug Safety Communication for a data summary and listing of general anesthetic and sedation drugs affected by this label change.
BACKGROUND: Anesthetic and sedation drugs are necessary for infants, children, and pregnant women who require surgery or other painful and stressful procedures, especially when they face life-threatening conditions requiring surgery that should not be delayed. In addition, untreated pain can be harmful to children and their developing nervous systems.
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.
RECOMMENDATION: 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.
Parents and caregivers should discuss with their child's health care professional the potential adverse effects of anesthesia on brain development, as well as the appropriate timing of procedures that can be delayed without jeopardizing their child's health. Pregnant women should have similar conversations with their health care professionals. Also talk with them about any questions or concerns.
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533195.htm
美國FDA發布藥品安全警訊，手術或療程中重複或延長使用全身麻醉及鎮靜藥物於小於三歲兒童或第三孕期之孕婦可能會影響幼童腦部發展。為了讓大眾知道麻醉鎮靜藥物之潛在風險，美國FDA要求在此類藥品仿單上增加此警訊，並持續監控兒童及孕婦使用麻醉與鎮靜藥物之情形。
兒童及孕婦在手術或執行一些疼痛處置時需要使用麻醉及鎮靜藥品，疼痛若不處理對於兒童的神經系統發展也會受影響。因此美國FDA建議醫療專業人員在兒童及孕婦身上使用麻醉鎮靜藥品時需謹慎評估，特別是手術或治療療程長達三小時以上或三歲以下幼童需多次使用此類藥物治療者。醫療專業人員於使用麻醉鎮靜藥品之手術和處置前須與家長、照顧者及孕婦說明麻醉鎮靜藥品對於孩童腦部發展的可能潛在風險和不會危害孩童健康之最適合手術的時機。美國FDA也提醒病人如有任何疑問或考量也須和醫療專業人員充分溝通。
相關訊息與連結請參考美國FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533195.htm
[Posted 12/14/2016]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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