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FDA Issues New Warning About Anesthesia for Children and Pregnant Women

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A new warning from the U.S. Food and Drug Administration may have some parents rethinking optional medical procedures that require their toddlers and babies to be sedated.

The FDA is cautioning that long and repeated stretches of anesthesia can adversely affect developing brains, despite an earlier study in the peer-reviewed Journal of the American Medical Association, which found limited exposure to anesthetics or sedatives for babies and toddlers is relatively benign.

Pregnant women in their third trimester are also included in the warning.

Anesthesia and sedatives are a medical necessity for anyone requiring certain types of surgery and other medical procedures. The FDA cautions that "untreated pain can be harmful to children and their developing nerve systems." However, doctors are being asked to use caution when balancing the need to sedate young children and pregnant women in their last trimester for procedures in excess of three hours due to the risk of "widespread loss of nerve cells in the brain."

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Their statement is based on studies done on young animals that showed changes in long-term behavior and learning. While research conducted on children revealed similar results, it's still unclear whether it is the drugs that are negatively impacting children's behavior and learning, or if the medical condition for which they're being sedated for treatment is, in fact, the culprit of the long-term affects.

The FDA said more research is necessary moving forward. Still, they are urging families not to rule out exposure to anesthetics without weighing the alternatives.

“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,” Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation Research, said.

An increased risk of attention deficit hyperactivity disorder, and learning and behavioral problems are among the issues that are cited as the possible outcomes of repeated long-term exposure to sedatives in young children.

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Families of small children who face more routine procedures, such as cavity fillings, tonsillectomies and appendectomies, should consult their doctors for any concerns, although those procedures generally range only from 15 to 90 minutes.

The FDA is requiring 11 drugs to add warnings to their labels.

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