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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children
AUDIENCE: Consumer, Surgery, Anesthesiology
ISSUE: FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These 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.
General anesthetic and sedation drugs are necessary for patients, including young children and pregnant women, who require surgery or other painful and stressful procedures. In the U.S., surgeries during the third trimester of pregnancy requiring general anesthesia are performed only when medically necessary and rarely last longer than 3 hours. FDA is advising that in these situations, pregnant women should not delay or avoid surgeries or procedures during pregnancy, as doing so can negatively affect themselves and their infants.
Similarly, surgeries or procedures in children younger than 3 years should not be delayed or avoided when medically necessary. Consideration should be given to delaying potentially elective surgery in young children where medically appropriate.
BACKGROUND: This is an update to the MedWatch alert "General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women" issued on December 14, 2016.
RECOMMENDATION: Health care professionals should continue to follow their usual practices of patient counseling including discussing the benefits and risks of surgeries or procedures that require general anesthesia and sedation drugs. FDA will continue to monitor the use of these drugs in children and will update the public if additional information becomes available.
Parents, caregivers, and pregnant women should talk to their health care professionals if they have any questions or concerns about general anesthesia and sedation drugs.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links the to new and previous drug safety communications, at:
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