ACOG and AAP Respond to FDA Warnings Against Sedation - Pregnancy - Delivery | Reiter & Walsh, PC

New FDA Guidelines Regarding Anesthesia and Sedation Drugs Prompt Debate

FDA Issues Warning on Anesthesia/Sedation Drugs in Pregnant Women and Young Children

In December 2016, the FDA issued a warning regarding general anesthesia and sedation in pregnant women who are in their third trimester. An FDA review of research found that the use of general anesthetics and sedation drugs may negatively affect brain development in the developing baby in-utero. They further extended this warning to children younger than 3 years.

New FDA Guidelines Regarding Anesthesia and Sedation Drugs Prompt DebateThe FDA’s Center for Drug Evaluation and Research released a Drug Safety Communication stating that repeated exposure or exposure more than three hours can adversely affect children’s developing brains by causing the widespread loss of nerve cells in the brain. Animal studies suggest that this can have long-term effects on behavior or learning.
The statement reiterated that medical professionals must carefully weigh the pros and cons of a given medical procedure, as many procedures that require anesthesia are medically necessary. The FDA now requires that sedation and anesthesia drugs be labeled with warnings regarding potential exposure risks.

The FDA’s recommendations are as follows:

  • Medical professionals should weigh the benefits and the risks of anesthesia in young children and pregnant women, especially for procedures that last 3+ hours or that require multiple exposures. Discuss benefits, risks and timing with parents, caregivers, and pregnant women.
  • Parents, caregivers and pregnant women should discuss potential adverse effects of anesthesia on brain development, and the timing of procedures that can be delayed without jeopardizing their child’s health.

ACOG Rebuts the FDA’s Warning, Says Fetal Harm Unlikely

Soon after the FDA released their warnings on sedation and anesthesia, the American Congress of Obstetricians and Gynecologists (ACOG) responded to the FDA warning. ACOG countered that they had ‘significant concerns’ about the FDA’s announcement, stating that the “clinical significance of these findings are unknown and could inappropriately dissuade clinicians from providing women with necessary care during pregnancy.” ACOG argues that the risks of exposure to dangerous conditions is low, and that animal studies may not map precisely onto drug effects in humans. Going forward, we see a division between the FDA’s warning-label recommendations and ACOG’s unchanged Committee Opinion 474.

Evidence Regarding Anesthesia Suggests Caution

It is an established fact, however, that sedation and anesthesia carry with them the risk of hypotension (low blood pressure). In pregnant women, low blood pressure can compromise blood and oxygen flow to the fetus, resulting in brain injury and cell loss. For example, it is know that hypotension occurs in almost ⅓ of mothers who opt for epidurals, with serious hypotension occurring a significant percentage of the time, and that slow heart rate (bradycardia) is another potential risk factor. During a hypotensive episode, the mother’s arteries dilate, making it difficult for the heart to pump blood to the baby, which can decrease the amount of oxygen-rich blood the baby receives. Because mothers also lie flat on their back during surgical procedures, this can further exacerbate low blood pressure issues, because this position compresses the aorta and vena cava. This can cause fetal distress due to oxygen deprivation, and must be managed appropriately to avoid hypoxic-ischemic encephalopathy (HIE) / neonatal encephalopathy(NE) (also known as birth asphyxia).

The Takeaway

It is very important that medical professionals fully inform mothers of the potential risks and benefits of anesthesia, especially since anesthetics can cross the placenta into the baby’s circulation, and may have an impact on the central nervous system, peripheral vascular tone and cardiac function. It is the medical professional’s responsibility to clearly delineate both benefits and risks of anesthesia and any other procedures mothers and children undergo to ensure that they can make fully informed decisions regarding their healthcare.

For more information on how anesthesia may impact children under the age of 4, please see our post on an article published in the New England Journal of Medicine.

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