Product News and Recalls

Recent FDA Warnings For 11 Anesthesia Drugs May Be “Disservice to the Population”

questions over fda advice on anesthetics in childrenSome doctors feel that new warnings now required by the FDA on 11 anesthetic and sedation drugs may cause parents and guardians to needlessly put off life-altering or even life-saving procedures for their children. The warnings detail how extended use of the drugs might lead to brain damage. They apply to children aged three and younger, as well as pregnant women in their third trimester. The FDA has encouraged doctors and parents to postpone such procedures when at all possible.

But regarding pregnant women, “these concerns are not new,” says Dr. Laura Riley, vice chair of obstetrics at Massachusetts General Hospital. Massachusetts General already avoids performing surgery on pregnant women unless there is clear indication it cannot wait until after childbirth. Such conditions include “a ruptured appendix or gallstones which can cause sudden pancreatitis, or inflammation of the pancreas, both of which can kill the mother and the fetus if not treated,” according to Forbes.

Certain other conditions may require infants to undergo longer exposure to anesthetics. Postponing surgery is often not an option for defects such as cleft palate and lip, or malformations in the urinary or gastrointestinal tract. Beyond those, many physicians “already try to minimize or postpone procedures requiring anesthesia or sedatives” because of the results of animal studies. They do so out of “an abundance of caution because the evidence that these drugs increase the risk of learning and behavior problems is far from conclusive.”

Concern has slowly grown over anesthetics being used on young children for extended periods of time since the late 90s. Results of studies initially conducted on rats revealed the possibility of long-term behavioral disorders. Studies in monkeys and young children have revealed similar possibilities, including weakened connection between brain cells. Thus far however, none have shown the brain damage to be irreversible.

Most animal studies to date do not account for the positive effects of surgery, and none have found a causal relationship between exposure to anesthetics and behavioral disorders in young children. Trying to find the same behavioral issues in humans as found in animals is particularly difficult because compared to other species, the human brain takes much longer to become fully developed.

Dr. Rita Agarwal, chair of the American Academy of Pediatrics’ Section on Anesthesiology and Pain medication, feels “the literature is so murky right now” and “that the FDA has done a disservice to the population by putting out these warnings.”

She may feel that way because every year more than one million children under the age of four undergo medical procedures that require anesthetics. For their part, the FDA says they “will update the public with additional information when it becomes available.”

But that could be years. As studies continue, parents and guardians must continue to make potentially life-altering decisions for their children with limited information.