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U.S. FDA warns on anesthesia use on infants, pregnant women

Xinhua, December 15, 2016 Adjust font size:

Lengthy use -- longer than three hours -- of general anesthetic or sedation drugs during surgeries may harm the brains of six-month-old fetuses and children younger than three years old, the U.S. Food and Drug Administration (FDA) warned Wednesday.

However, a single, relatively short exposure to general anesthetic or sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning, the agency said.

The FDA said the warning was based on a comprehensive analysis of the latest published scientific studies.

"To better inform the public of the risks, we are requiring warnings to be added to the labels of these drugs," Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said in a statement.

"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," Woodcock said.

According to the FDA, animal studies have shown the use of general anesthetic and sedation drugs for more than three hours caused widespread loss of nerve cells in the brain, which have been linked to long-term effects on the animals' behavior or learning.

Studies have also been conducted in children, some of which supported findings from the animal studies, particularly after repeated or prolonged exposure to these drugs early in life, it said.

The FDA noted that all the studies in children had limitations. It's unclear whether any negative effects seen in children's learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery.

The U.S. agency said it has been investigating the potential adverse effects of general anesthetic and sedation drugs on children's brain development since the first animal study on this topic was published in 1999.

It has also formed a partnership with the International Anesthesia Research Society to fund research in this area. Endit