ACOG Response to FDA Communication on Anesthesia in Pregnancy

SUMMARY:

In 2016, the FDA released a warning stating that repeated or lengthy use of general anesthetic or sedation drugs in children less than 3 years of age or in pregnant women in their 3rd trimester may be harmful to children’s brain development. The FDA issued an update (2017) requiring warnings to be added to labels of these medications. The FDA does point out in the update that the concern relates to procedures >3 hours and that most surgeries in the 3rd trimester are generally well within that time frame. Therefore, the FDA safety communication states

We are 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

In response to the initial warning, ACOG released a practice advisory (2016) making the following important points

  • The data used to derive this warning were obtained from a pediatric study only – no pregnant women were included
  • There are potential negative clinical implications if healthcare professionals hesitate in providing appropriate care and management
  • The FDA did not seek input from ACOG and obsetetrician-gynecologists were not involved in the development of this warning

As a result of the above and based on current evidence

ACOG continues to recommend that women in any trimester of pregnancy should be counseled regarding evidence-based benefits and risks of any proposed interventions which may involve the use of general anesthetic or sedative agents, and no woman should be denied a medically indicated surgery or procedure which may involve the use of these agents

ACOG and the American Society for Anesthesiologists (2019) confirmed the above in their committee opinion and state that presently there is “no evidence that in utero human exposure to anesthetic or sedative drugs has any effect on the developing fetal brain.”

Learn More – Primary Sources:

ACOG / American Society of Anesthesiologists Committee Opinion 775: Nonobstetric Surgery During Pregnancy

FDA Drug Safety Communication: FDA approves label changes for use of general anesthetic and sedation drugs in young children

Does General Anesthesia Exposure in Infancy Impact Neurodevelopment?