Dr. Janet Woodcock, U.S. Food and Drug Administration (FDA) director at the Center for Drug Evaluation and Research, recently issued a statement on behalf of the FDA regarding new safety information on the use of anesthesia in young children and pregnant women.
“The health of our nation’s children is a responsibility that the FDA takes very seriously,” Woodcock said. “Parents and caregivers are often concerned when their young child requires a medical procedure for which anesthesia or sedation drugs are necessary. Understandably, there are many questions, including whether the drugs are safe for their child. Pregnant women who must undergo medical procedures that require anesthesia or sedation drugs have similar concerns.”
Woodcock went on to say that the FDA would be releasing a Drug Safety Communication to inform health care providers, parents and caregivers of children under the age of three -- as well as pregnant women in their third trimester -- that the use of anesthesia and other drugs used for sedation could lead to adverse effects on children’s brains.
The Drug Safety Communication will be based on comprehensive analysis of recent scientific studies conducted by the FDA.
