Concerns that labeling changes on anesthesia might discourage pregnant women from getting medical procedures are unwarranted.
Flash advice from the FDA! Avoid putting your infant under sedation for 3 hours or more. But if medically necessary, go right ahead.
Question: Who is going to put a child younger than 3 years old under a lengthy surgical procedure without medical necessity?
Answer: Doctors everyone should avoid.
The FDA is alerting parents and doctors that more than 3 hours of anesthesia can “cause widespread loss of nerve cells in the developing brain; and studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.” (Note: Animal studies are often, but not always, predictive of human responses.)
Sometimes even small children need surgery. A heart problem can’t be put off or a cleft lip has to be addressed very early in life so that the infant can feed properly. In those cases, the new guidelines might help prepare parents for future cognitive and behavioral challenges. The FDA’s warnings about nerve cell damage won’t likely be a deciding factor when the stakes are life or death. It may encourage parents of children who need surgery for non-life threatening deformities to wait as long as possible.
Labels Dissuading Pregnant Women?
The same animal studies raised identical concerns about long exposure to anesthesia in the last trimester of pregnancy, which is when most of the fetus’ brain growth occurs. The label mentions pregnant women, but the warning is specific to infants up to 3 years old.
The medical news site, STAT, noted that, “Some experts had raised concerns that the labels would dissuade pregnant women from undergoing necessary medical procedures, and FDA officials said the revisions came from ongoing discussions with experts.”
The suggestion that information should be withheld from women for fear that women won’t make a medical decision that the doctor doesn’t agree with is something I find deeply disturbing. Hopefully, it’s not true. If so, my message to the FDA and to doctors is please allow pregnant women the same courtesy and respect you should to all patients. Informed consent is cornerstone of good patient care and women are perfectly capable of making the right decision for herself and her fetus.
