General Anesthetic and Sedation Drugs FDA Approves Label Changes for Use in Young Children - American Society of Anesthesiologists (ASA)

FDA & Washington Alerts

General Anesthetic and Sedation Drugs: FDA Approves Label Changes for Use in Young Children

On Thursday, April 27, the United States Food and Drug Administration (FDA) released a Drug Safety Communication, approving the previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes were announced in a December 2016 communication.

In the December 2016 communication, FDA concluded “repeated or lengthy use of general anesthetic or sedation drugs during surgeries or procedures in children younger than three years of age or in pregnant women during the final trimester may affect development of children’s brains.”  The FDA defined lengthy as greater than three hours of exposure.

Information included in the new Drug Safety Communication states these label changes include:

•             A new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.
•             Addition of information to the sections of the labels about pregnancy and pediatric use to describe studies in young animals and pregnant animals that showed exposure to general anesthetic and sedation drugs for more than 3 hours can cause widespread loss of nerve cells in the developing brain; and studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.

The FDA has issued these warnings to raise awareness among practitioners and the public to ensure the information needed to make informed judgments about the risks and benefits of anesthesia and sedation in young children and pregnant women is widely available. ASA agrees that awareness and education on this topic is important for patients and clinicians. After the initial communication from FDA, ASA and several other medical societies issued a consensus statement.

In part, the statement emphasized:

The potential risk of negative cognitive or behavioral effects of anesthetic agents remains uncertain and must be placed in the context of the known risks and benefits of both the anesthetic and the related surgical or diagnostic procedure for which the anesthetic is required.  Clinicians and parents are cautioned against the possible risk of delaying needed surgical or diagnostic procedures. It is not yet known whether the anesthetic drug or some other factor is responsible for these findings.  Rigorous research to further characterize any possible associations is ongoing.  Until additional information is available from ongoing studies, parents and providers should carefully weigh the risk and benefit of each contemplated procedure before proceeding. 

Additional information may also be found at www.smarttots.org. SmartTots is a public private partnership between the FDA and the International Anesthesia Research Society.

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