Continued sedation a brain risk for children

WASHINGTON: Repeated or lengthy use of general anaesthesia or sedation drugs for children younger than 3 or pregnant women in their third trimester may affect youngsters’ developing brains, according to the US Food and Drug Administration (FDA).

The agency, which said its warning is based on a comprehensive analysis of the latest research, issued a “drug-safety communication” to inform health-care providers, parents and pregnant women about the risks of using the drugs repeatedly or for more than three hours at a time. It also ordered manufacturers to add warnings to their products’ labels.

“We recognise that in many cases these exposures may be medically necessary,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement. The new data on potential harms, she said, “must be carefully weighed against the risk of not performing a specific medical procedure.”

The agency said that laboratory studies show that using the drugs in pregnant or young animals for more than three hours at a time causes widespread loss of nerve cells, which correlated with longterm effects on learning and behaviour.

Some studies have also been conducted in children, with some supporting the findings from the animal research, particularly after repeated or prolonged exposure to the drugs early in life. But all the studies in children had limitations, and the FDA said that “it is unclear whether any negative effects seen in children’s learning or behaviour were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.”

A single, short exposure to the drugs is unlikely to have a negative impact, the agency added.

More than 1 million children under age 4 require anaesthesia for surgery in the US each year, for conditions such as congenital heart defects or pyloric stenosis, which is a narrowing of the opening from the stomach into the small intestine. – The Washington Post