Dr. Dean B. Andropoulos authors article in NEJM about FDA drug safety warning

February 21, 2017

Anesthesiologist-in-Chief Dr. Dean B. Andropoulos recently authored an article in the New England Journal of Medicine (NEJM) about the December 14 U.S. Food and Drug Administration (FDA) drug safety communication about prolonged or repeated anesthetics in young children and pregnant women in their third trimester.

The FDA’s communication states:

  • A single, short exposure to anesthesia appears to be safe.
  • There is some evidence that longer (>3 hours) or repeated exposures could have negative effects on behavior or learning.
  • Much more research is needed.

As a result of the communication and after deliberating with leaders in his department as well as the Department of Surgery and risk management, Andropoulos said in the NEJM article that Texas Children’s Hospital has changed its anesthesia practice and will discuss the warning before surgery with the parents of all children 3 years of age and younger.

In addition, Andropoulos said in the article, Texas Children’s Hospital has adopted the warning’s recommendation that a discussion occur among parents, surgeons, other physicians and anesthesiologists about the duration of anesthesia, any plan for multiple general anesthetics for multiple procedures, and the possibility that the procedure could be delayed until after 3 years of age. Parent-education materials that cover these topics also will be made available to our patients and their families.

“Even though anesthesia is much safer today than ever before, every anesthesia exposure and surgery has an element of risk and we must remain vigilant about communicating such risks to our patients and their families,” Andropoulos said. “In addition, the benefits of anesthesia must always be weighed against the risks of anesthesia itself.”

For more information, please contact the Texas Children’s Hospital Department of Anesthesiology, Perioperative and Pain Medicine at ext. 4-5800. To read a blog by Andropoulos titled “Anesthesia and Your Child,” click here.