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(Excerpted from Associated Press, Thursday, March 29, 2007)

Potential anesthesia risk for children has government worried

Anesthesia can be harmful to the developing brain, studies on animals suggest, raising concerns about potential risks in putting young children under for surgery.

Food and Drug Administration scientists stressed Thursday they have no evidence that anesthesia and sedation drugs, which have been commonly administered for decades, can cause brain damage in children.

But numerous animal studies find that a majority of the drugs typically used to knock out children before surgery do kill brain cells in young rats, mice and preliminary results suggest rhesus monkeys. ...

The FDA published the study and convened a public meeting to alert other experts to its concerns, as well as to update them on research and outline tentative plans for future studies.

Some drugs appear to cause more harm to animals than others, the FDA and other experts said. Furthermore, in some drugs both dose size and duration may affect the brain differently. And some combinations of drugs like the triple "cocktail" of isoflurane, midazolam and nitrous oxide may be more toxic to the brain than any one used individually.

Still, panel members agreed unanimously that there isn't enough information to say any one drug or drug combination is safer than any other.

The animal studies suggest young animals are most susceptible to the drugs during the period of rapid growth of the brain. In humans, that period begins before birth, in the third trimester, and extends to about age 3. An estimated 600,000 children within that age range receive general anesthesia each year in the United States, including during operations to place ear tubes, repair hernias or stitch up serious wounds, said Dr. C. Dean Kurth, anesthesiologist-in-chief at Cincinnati Children's Hospital Medical Center.

Many of the operations performed on children are to save their lives or improve their quality of life. Since they're typically not elective, skipping or even delaying such surgeries would have its own risks, according to FDA officials.

"We're certainly not looking at saying anesthesia should not be used on children," Rappaport told The Associated Press, adding that it's generally considered one of medicine's greatest advances.

Nor are there any good alternatives to the current menu of anesthetic drugs, experts said. And surgery ethically cannot be performed without anesthesia.

"These findings have potentially important public health implications, and pose a therapeutic dilemma for physicians," said Dr. John Olney, of Washington University School of Medicine. ...




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•   Potential anesthesia risk for children has government worried

Associated Press, Thursday, March 29, 2007
Byline: Andrew Bridges, Associated Press Writer


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Revised:

Thursday, Aug. 2, 2007


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