FDA Warns Anesthetic Drugs May Cause Brain Damage in Young Children

The FDA yesterday issued a drug safety communication regarding the use of general anesthetics and sedation drugs in young children and women who are pregnant.

The agency warns that repeated or prolonged exposure to general anesthetics and sedation drugs during surgical procedures may affect brain development in children younger than 3-years-old and women who are in their third trimester of pregnancy, according to an FDA press release.

Recent findings suggest that a single, short exposure to these drugs in infants and toddlers is not likely to have a negative impact on behavior or learning, which is consistent with the findings in animal studies, according to the FDA.

However, the FDA said additional studies are needed to better understand how exposure to these drugs during early life may affect brain development, and when it would be considered safe to administer these drugs to young children.

The new warnings about potential adverse events will be added to the labels of anesthetic and sedation drugs. The FDA will continue to monitor use of the drugs in these populations, and will provide necessary updates when additional information becomes available, according to the release.

Certain infants, young children, and pregnant women may require anesthetic and sedation drugs due to medically necessary surgeries or procedures, especially when a life-threatening condition is present.

The FDA advises healthcare professionals to weigh the risks and benefits of anesthesia use in children and pregnant women, especially if the procedure lasts longer than 3 hours, or if the patient will undergo multiple procedures.

Parents and caregivers of young children should discuss the use of anesthetic drugs with their child’s healthcare professional to ensure that brain development risks are fully understood. Optimal timing of procedures should also be discussed to determine whether they can be delayed without putting the child at risk.

Pregnant women should also discuss these risks with their healthcare professionals, according to the FDA.

Findings from published studies exploring the use of these drugs in pregnant and young animal models suggest that exposure for longer than 3 hours results in a loss of nerve cells in the brain. Young animal studies showed long-term effects on behavior and learning, which were supported by the findings of studies in children, especially after repeated or extended periods of time.

All studies involving children have had limitations, and it is unknown whether the negative cognitive effects were a result of the drug or underlying medical conditions that led to the surgery, the FDA said.

The agency has been investigating the adverse events of these drugs in children since the first animal study was published in 1999, according to the press release. As a result, advisory committee meetings were held in 2007, 2011, and 2014.

More research is needed to determine the proper, safe use of these drugs in young children and pregnant women, and individuals are encouraged to report any side effects to the FDA MedWatch program, the FDA concluded.