Home E-Weekly May 2, 2017

Anesthesia Warning Labels for Children, Pregnant Women Approved

Published: May 1, 2017

BRAIN DRAIN? Exposure for more than 3 hours may lead to long-term negative effects, says the FDA.

Following up on a previous safety alert, the FDA has approved label changes regarding the use of general anesthesia and sedation in children younger than 3 years and in women in the third trimester of pregnancy.

The new warnings say that exposure for "lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years."

However, in an acknowledgement of concerns expressed by physician groups, the warning will emphasize that necessary surgeries requiring anesthesia shouldn't be delayed or avoided for either group.

Last December, the American College of Obstetricians and Gynecologists (ACOG) issued a practice advisory expressing concern that the wording of the FDA's alert could "inappropriately dissuade providers from providing medically indicated care during pregnancy," adding that it was "unaware of data on pregnant women that support the FDA's claims."

The FDA says studies in young animals and pregnant animals have shown that "exposure to general anesthetic and sedation drugs for more than 3 hours can cause widespread loss of nerve cells in the developing brain," resulting in "long-term negative effects on the animals' behavior or learning."

Jim Burger

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