The U.S. Food and Drug Administration (FDA) warned last month that repeated or lengthy use of general anesthetic and sedation drugs in pregnant women and children under 3 may harm brain development.

Based on comprehensive analysis of the latest scientific research, the agency issued a warning on Dec. 14 to inform health-care providers, parents, and pregnant women in their third trimester long or repeated exposure to the drugs could adversely affect children’s brains.

As part of the drug safety communication, the FDA announced it is requiring manufacturers of 11 general anesthetic and sedation drugs, including ketamine and propofol, to include warnings of potential risks on its labels.

“To better inform the public about this potential risk, we are requiring warnings to be added to the labels of general anesthetic and sedation drugs,” the FDA said in its announcement. “We will continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available.”

FDA Urges Discussion of Risks and Benefits

More than a million children under the age of 4 undergo anesthesia each year in the United States alone. Most of the cases involve non-emergency procedures like hernia repairs and circumcisions but some involve more serious medical conditions like surgery for congenital heart defects.

Despite the warning, the FDA emphasized that some procedures are medically necessary and that the risks need to be weighed against the benefits.

“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,” the FDA said. “In addition, untreated pain can be harmful to children and their developing nervous systems.”

According to the FDA, a single and relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.

Some doctors agreed.

“There is no evidence to suggest that short procedures should be postponed, but parents should always discuss with their child’s pediatrician and surgeon the risks and benefits of timing of procedures,” Dr. Constance Houck, chair of the American Academy of Pediatrics’ Surgical Advisory Panel, told Rita Rubin in Forbes.
But some critics are concerned that the warnings on the labels will discourage women from undergoing necessary procedures. The FDA is adamant that the warning should not prevent life-saving operations.

“We recognize that in many cases these exposures may be medically necessary and these new data regarding the potential harms must be carefully weighed against the risk of not performing a specific medical procedure,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement.

FDA Warning Comes Under Fire From Obstetricians

Although the FDA based its warning for potential risks in young children on both clinical human studies and animal studies, no human clinical studies were used to show a connection between anesthesia used during pregnancy and harm to fetal brain development.

The American College of Obstetricians and Gynecologists (ACOG) was not pleased with this overly cautious warning and issued a practice advisory to its members in response.

“ACOG is unaware of data on pregnant women that support the FDA’s claims,” the group said. “The FDA did not seek input from ACOG, obstetrician-gynecologists, and other obstetric providers; such input would have been valuable in the development of this published safety announcement.”

Based on current evidence, the ACOG said it will continue to recommend that women in any trimester of pregnancy should be counseled on the risks and benefits of procedures involving general anesthetic or sedation drugs and undergo the procedure is necessary.

“The risks associated with inappropriately withholding these medications include delaying the performance of medically indicated procedures, withholding a medically indicated procedure or substituting it with a less-appropriate procedure, and the potential for unnecessary discomfort or pain,” the nonprofit organization said. “In addition, this announcement is in direct contradiction to longstanding experience, clinical guidance, and the current standard of care.”

The FDA admits that more research needs to be done to provide additional information needed about the safety of the drugs in young children and pregnant women.