FDA Issues Warning for Anesthetic Drug Use in Young Children

The FDA has issued a drug safety communication for young children and pregnant women regarding the use of general anesthetic and sedation drugs during surgeries or procedures.¹ The new warning indicates that these drugs may cause damage to the development of children’s brains with repeated or lengthy use.

Label warnings will now be required by the FDA to inform the public about the potential risk to children’s brain development. The use of general anesthetic and sedation drugs will continue to be monitored by the FDA for further information about adverse events. The FDA encourages health care professionals to assess appropriate use of these drugs and balance the benefits against potential risks with each patient, especially for procedures taking longer than 3 hours or in multiple procedures required for children younger than 3 years old.

Recent human studies indicate that a single, relatively short exposure to general anesthetic and sedation drugs does not have negative effects on behavior or learning, which is consistent with findings from animal studies, according to the FDA. However, more research is needed to determine exactly how this exposure adversely affects children’s brain development.

Anesthetic and sedation drugs are sometimes needed for use in infants, children, and pregnant women who must undergo surgery or other painful procedures, and it is often necessary in life-threatening conditions.

Pregnant women should discuss any questions or concerns with health care professionals, and parents and caregivers should discuss their child’s health and any potential adverse effects as well. The FDA encourages health care professionals and patients to report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Reference

• General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women. FDA website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533195.htm. Accessed Dec. 15, 2016.