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FDA, pregnancy, prematurity

As an OB/GYN and parent I find the FDA’s statement on anesthesia risks offensive. Here’s why.

imagesThe Food and Drug Administration (FDA) recently issued a warning regarding the potential dangers of anesthesia in pregnancy and for young children. Specifically that “repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.” The FDA did not involve the American Congress of OB/GYN (ACOG) with this statement. You can read the full FDA statement here and ACOG’s response here.

As a woman who had some of these drugs in my late second trimester, as a parent of a child who needed anesthesia three times before the age of three, and as an OB/GYN who has cared for pregnant women who needed prolonged anesthesia because of horrific circumstances I say to the FDA hey thanks for making a difficult situation worse.

The warning about 3 hours and repeat anesthetics is based solely on some animal studies that show the use of some specific agents for sedation and anesthesia have caused widespread loss of neurons in the brain and “long-term effects on the animal’s behavior or learning.” Making such a broad statement based on animal studies, some of the supporting research from nematodes no less, especially considering the reasons these anesthetics are needed is just not acceptable. Context is everything. For example, a nematode study is really of no consequence when you are triaging a pregnant woman at 26 weeks with a gun shot wound to her chest.

There are obviously major confounders with the human studies, meaning the serious illness that led the pregnant woman or the child to need repeat anesthesia or a 3 hour anesthetic. These situations arise because of medical nightmares, a serious illness, or an accident. Obviously, these situations might also be associated with cerebral blood flow changes, infection, medications, stress and numerous other interventions and medical events that could affect a developing brain. This part is pretty much glossed over in the statement.

I needed some of the drugs listed twice at 22 weeks and 4 days. Twice in one day probably counts as repeated and yes is suboptimal on paper but there was no other option. Then one of my sons had an anesthetic when he was 1200 g. Born at 26 weeks his critical pulmonary stenosis needed repair when he was about 6 weeks old. At 1200 g he was big enough for the smallest equipment and at this point the balance of risks seemed to favor his benefit from the procedure versus doing nothing. It was a kind of a double whammy risk for anesthesia, he was both an infant and had a third trimester brain. It was not a short anesthetic as getting a catheter into a tiny femoral artery and snaking it up through one tiny heart valve and then another abnormally smaller heart valve (both moving targets) is technically challenging. His anesthesia exposure didn’t stop there. He also had a hole in his heart repaired at two years of age and an ICU stay for pneumonia at two and a half years that both required sedatives on the list.

Before his first heart procedure I was warned about the potential risks of the anesthesia. I was told this was about the worst time to get one, but it was done in a very kind way and the pediatric cardiologist and neonatologist and anesthesiologist had thought long and hard about his condition and consulted with some other experts and there didn’t appear to be any other option. Doing poorly in the here and now versus potential, and definitely far from certain, brain risk. That was the choice.

This last part, that some surgery is NEEDED, isn’t really addressed by the FDA until the “additional information” part. In fact, why a pregnant woman or young child needs a 3 hour anesthesia isn’t the additional part, it’s the main thing.  As an OB/GYN I can say that repeat or prolonged anesthetics in the third trimester only happen in dire situations. Something like a fractured femur from a car accident. A ruptured spleen. A gun shot wound. A brain tumor. A pregnant woman with triplets whose first baby delivered at 22 weeks and 4 days and was in too much distress and pain to have the cord cut short from her first delivery and then a few hours later get a cerclage to try to salvage her remaining two without sedation. Some situations simply can’t wait for the pregnancy to be delivered or are needed to prevent the delivery. Some children need surgery for birth defects, trauma, or cancer.

Anesthesiologists, OB/GYNS, and surgeons all know the shortest anesthesia is the best one. This doesn’t just apply in pregnancy or to children, by the way. I think it’s great that the FDA has partnered with the International Anesthesia Research Society (IARS) to work on strategies to reduce potential neurotoxicity from anesthesia, but it would have been nice if they had also partnered with ACOG or at least given them a heads up. And what of the warning labels? Even if these anesthetics do cause these risks if there are no other options what are you as a surgeon or as a parent or as a pregnant woman supposed to do in the here and now if the surgery is organ, limb, or life saving?

I could understand if pregnant women and children were showing up in droves for long cosmetic procedures or pleasure surgeries, but honestly the only pregnant person or child who gets a three hour anesthesia is one who needs one. Blood loss, sepsis from a perforated bowel, an unset femoral fracture, sky high bilirubin levels, pulmonary valve stenosis causing low oxygen levels and right ventricular hypertrophy. These are not exactly acceptable alternatives.

It’s possible my anesthesia and son’s anesthetics were bad for his brain, but the health issues caused by my delivery at 22 weeks and his heart conditions were definitely bad for his life. Some of us are in the sad situation of simply picking the lesser evil and these tone-deaf non reality based statements really irk me. The FDA statement and warning labels offer no practical solutions and have the added bonus of tightening the Gordian knot for those of use who have to deal with these difficult situations, either personally or professionally.

As a doctor I see the statement as tone deaf outreach given they have provided no data that unnecessary and prolonged anesthesia for pregnant women and young children is a rampant issue and offered no proof of causality between anesthesia exposure and neurological consequences. The cynic in me wonders why this statement now as there is no new, pivotal research? As a parent I find the added worry offensive given the lack of alternatives, especially as the part about these surgeries being generally necessary is not in the lede.

The money that went into this statement and the money that will be spent changing labels would be far better spent on researching safer alternative anesthesia and on research and education on practical ways to shorten surgical times.

 

Discussion

5 thoughts on “As an OB/GYN and parent I find the FDA’s statement on anesthesia risks offensive. Here’s why.

  1. Oh god. More calls from the ER. “Can we give anesthesia to the woman bleeding to death?” “Yes, Dead women make bad mothers.”

    Posted by WomanWhoWeaves | January 2, 2017, 12:12 pm
  2. Perhaps your son would have died had you waited until he was over 3 to have his birth defects surgically repaired, but that is not true of every baby and toddler who has surgery. Some surgeries could be postponed safely or altogether avoided. There is some evidence from human studies that the cognitive impairment seen experimentally in mammals including primates – not just nematodes – occurs in humans. This is not surprising, as we are after all animals. Parents have the right to know the potential harms as well as the benefits, and doctors have the responsibility to know them. A doctor who has not learned about these harms, because she believes that it is unacceptable to count nonlethal harms when life may be at stake, will more easily coerce parents in less critical situations into believing that surgery is the only possible or tolerable choice.

    Posted by jane | January 3, 2017, 8:34 am
    • i suppose my 1 year old didn’t *need* general anesthesia to have his spica cast placed when his femur was broken but it would have been cruel to do anything else

      Posted by Demodocus | January 4, 2017, 7:48 am

Trackbacks/Pingbacks

  1. Pingback: Anesthesia in Pregnant Women And Young Children: The FDA Versus ACOG | Kennerly Loutey - January 2, 2017

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