Safety of botulinum toxin injections in children less than one year old: A retrospective chart review.
Nikhil Deshpande, Mark E Gormley, Supreet Deshpande
PMID 37574745WHAT IT FOUND
In 47 infants treated with botulinum toxin, only two reported adverse events.
One had transient fever and vomiting, and one had mild weakness. No significant systemic issues occurred at doses below 16 U/kg, suggesting the treatment may be safer than feared in this age group.
Key findings
01Forty-seven patients received 59 injections, with diagnoses including brachial plexus injury, cerebral palsy, clubfoot, sialorrhea, and torticollis.
02Only two patients reported adverse events: one had fever, vomiting, and diarrhea, and another had subjective biceps weakness that resolved by four months.
03The authors concluded that no significant adverse effects were caused by doses less than 16 U/kg with onabotulinumtoxinA, 9 U/kg with abobotulinumtoxinA, or 4 U/kg with incobotulinumtoxinA.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTsWhat it means for SLPs
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What it does not show
The study is a retrospective chart review, so adverse events may have been underreported or missed if parents did not report them. The sample size is very small (47 patients), and the patients had diverse diagnoses, muscles injected, and doses, making it difficult to draw strong conclusions. The follow-up period varied from two to 16 weeks, which may not capture delayed or long-term adverse effects. The authors state that some doses used were outside FDA-approved guidelines for older children, and the study does not recommend these doses.
Declared interests
The paper does not report any conflicts of interest or funding sources in the provided text.
The easy way to misread this
Do not interpret the low number of reported adverse events as proof that botulinum toxin is safe for all infants. This was a small retrospective review with variable follow-up and potential underreporting of side effects, and the doses used were sometimes outside approved guidelines for older children.