Botox for... Babies?!

But maybe we shouldn't?

I recently came across this 2023 retrospective review article by Nathan Lu et al: "Use of Botox for sialorrhea and dysphagia in the neonate population"

It discusses cases where Botox injections were given to neonates (ie: medically compromised babies) for reduction of hypersalivation (known by the medical term "sialorrhea").

The goal is an admirable one, to hopefully reduce choking, oxygen desaturations, and risk of aspiration pneumonia in premature babies by reducing their saliva production.

Unfortunately, the method is a very dangerous one.

In fact, in two of the six cases they reviewed, after Botox injections, the babies went into respiratory distress and required tracheostomies. The article states, "No adverse events related to BoNT injections occurred. Although two of our patients (33%) did go on to require surgical airway interventions, this was due to their underlying neurological deficits and not a result of salivary BoNT injection."

I sent the author the following questions I have regarding this experimental use of Botox:

1. Do we know how researchers are assessing neonates for mild botulism symptoms after BoNT injections (including dizziness, nausea, headaches, blurry vision, dry mouth/eyes, etc.)? Because these are mostly subjective experiences, I worry about premature babies having no way to communicate if they are experiencing mild botulism symptoms.

   
   

2. How are researchers determining unit amount for neonates? The article states that babies were given 5-15 units of BoNT per session. A 1994 study on macaques done by Allergan showed that the NOEL was 4 units per kg under the conditions of their study. The mean weight of the babies in the study was 4 kilograms (range = 3.03-6.12 kg).

   
   

3. For the two cases you reviewed where the babies developed respiratory distress and need for trachs after injections, how was it determined that their distress was due to their underlying neurological deficits vs. potential BoNT toxin spread? (respiratory distress and aspiration pneumonia are two common complications of BoNT toxin spread.)

I have not heard back yet, but will update this blog post if and when I do.

I want to shout this from the rooftops:

Anytime anyone is injecting Botox into humans or animals that cannot reliably communicate, it is IMPOSSIBLE to rule out mild botulism symptoms.

Mild botulism is a set of subjective experiences due to autonomic nervous system disruption (blurry vision, dizziness, nausea, headaches, fatigue, dry mouth, dry eyes, difficulty swallowing/breathing that is not necessarily measurable on objective testing, etc.)

You will not be able to tell if a baby is experiencing mild botulism. They cannot fill out a quick 2-minute survey about their symptoms. Any mild botulism symptoms they might develop will not show up on testing. They might be incredibly fussy, but so are many babies in the NICU.

We know from Botox's own package insert that the population most at risk of developing botulism symptoms from toxin spread are medically compromised children.

I'm doing my best to view this research as objectively as possible, but given what I know about iatrogenic botulism and my primal desire to protect those who cannot speak for themselves, I cannot help but see this as an unethical experimental use of botulinum toxin.

I'm not a NICU SLP, so to be fair I have limited knowledge about this population and setting... but I wonder if it might be smarter to stick to oral suctioning when needed?

References:

“A One-Year Intramuscular Toxicity Study of Botox in the Cynomolgus Monkey.” https://nxstrib-com.go-vip.net/wp-content/uploads/sites/3/2013/05/study-no-91-3708.pdf