Repeated or prolonged use of general anesthesia and sedation drugs in infants, toddlers and pregnant women in the third trimester may damage children, the development of the brain, the U.S. Food and Drug Administration warned this month.
Angry that the warning for pregnant women based solely on animal testing, the American College of Obstetricians and Gynecologists, or ACOG, a shot back of her objection.
“ACOG is unaware of data on pregnant women that the FDA’s claims,” the group said in a practice advice to its members. “These warnings can lead to the patients and providers unlawful to deny the use of this medically indicated drugs.”
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Dr. Chris Zahn, vice-president of practice activities for ACOG, said that the nonprofit, which represents doctors who care for women, and the FDA has had a close cooperation, and in the past have discussed similar warnings before they were announced. But the warning for pregnant women and anesthesia was different.
“We were caught completely off guard, and we are concerned about the practical applicability of this warning and the potential negative impact on the health of women, especially pregnant women,” Zahn said in a telephone interview.
On 14 December, the FDA issued a safety announcement urging that health-care providers, parents and patients weigh the benefits against the risks, taking into account the timing of non-emergency surgery, in particular for pregnant women in the third trimester and in children less than 3 years old (http://bit.ly/2gJqhnH).
The FDA on the basis of the security advice – and a requirement that drug manufacturers add warning labels on the 11th of anesthetic and sedation drugs in both clinical and animal studies. But the human studies are only children, not pregnant women.
Studies have shown that more than three hours of general anesthesia and sedation drugs in pregnant and young animals caused widespread loss of nerve cells in the offspring of the brain, the FDA spokeswoman Sarah Peddicord said. Research shows adverse effects on the behaviour and development of the brain is done in multiple animal species, from flatworms to non-human primates.
The question is why the FDA included pregnant women without clinical evidence of a problem, Peddicord said, “This is something we can investigate, and on the basis of the information that we have, we thought it was important to present the information to the public.”
At the same time, the FDA announcement is trying to reassure a number of parents of children who are considering surgery. “In accordance with animal studies, recent studies suggest that a single relatively short exposure to general anesthesia and sedation drugs in infants and young children is unlikely to have negative effects on the behavior and learning,” it says.
The FDA and the ACOG both agree that more research is needed. To that end, in 2010, the FDA and the International Anesthesia Research Society founded SmartTots, a public-private partnership for the study of the gaps in the knowledge about the safe use of anesthetics and sedatives in children.
Approximately 2 million American children under anesthesia to undergo an annual, usually for a general, non-emergency procedures, such as hernia repairs, circumcisions and tonsillectomies.
Dr. Lena Sun, professor of anesthesiology and pediatrics at Columbia University Medical Center in New York City, is the study of the problem in children and said she believes the FDA has acted in an abundance of caution.
“We should not unnecessarily alarm the public, but we want the public to be aware of this potential risk,” she said in a telephone interview.
“While we are pretty sure and not have to worry that a single and short positions in healthy children, should not ask, we can’t offer the same reassurance for long-term and repeated exposure,” she said.
Sun, however, is not aware of any studies in humans indicating the exposure of pregnant women to anesthesia is harmful for the brain of theirnborn children.
Dr. Maurice Druzin, professor of obstetrics and gynecology at Stanford University School of Medicine in California, described the FDA the integration of the pregnant women in the advice-as “unfortunate” and “inappropriate scare tactics.”
“A patient will say, ‘wait a minute; I don’t want to have this surgery, because it’s going to destroy my baby’s brain cells,'” Druzin told Reuters Health.
Eventually, though, he said he expected the warning to have little influence on his obstetrics practice, because he rarely use of general anesthetics today.