Our Smallest Victims: The Dangerous Off-Label Use of Botulinum Toxin in Children
Jackson Wells was three years old. He was learning to talk, starting to walk, and could feed himself. Hours after receiving six therapeutic injections of Botox in his legs for muscle spasms, he was on a ventilator, fighting for his life with a diagnosis of botulism.
Jackson’s horrific experience pulls back the curtain on one of the most disturbing uses of botulinum toxin: its "off-label" application in children. "Off-label" means the drug is being used for a purpose or in a population that the FDA has not formally approved. While legal, it means the safety and efficacy have not been established, placing a heavy burden of risk on vulnerable patients and their families.
A Modern Case Study: Treating Newborns with a Neurotoxin
This isn't just a historical problem. A 2023 study from UPMC Children's Hospital of Pittsburgh provides a stunning, modern-day example of this practice in the most fragile patients imaginable: six newborn infants in the NICU.
The Patients: The average age at the first injection was just 1.5 months old, and their average weight was only 4 kg (about 8.8 pounds). All were medically fragile and required feeding tubes.
The Paradox: Incredibly, the study's stated purpose was to review the use of Botox for dysphagia (difficulty swallowing)—using a neurotoxin to treat the very symptom it is most famously warned to cause.
The Results: The study's own data revealed a critical failure: "there was no noted clinical improvement in oral skills post injection.". Worse, one-third of these tiny infants still required major surgical airway intervention, like a tracheostomy, after the Botox treatment.
Despite the treatment failing to improve swallowing and patients still needing life-altering surgery, the authors concluded that the procedure is a "safe, non-invasive alternative.".
The Buried Evidence of Harm
This conclusion, which ignores the study's own damning results, is deeply troubling. It's even more so when viewed in the context of the historical, buried evidence of harm.
A Confidential Allergan Report: A 2008 internal analysis from Allergan, the maker of Botox, documented 13 pediatric deaths in the U.S. over the previous 18 years following treatment with their product.
FDA Regulatory Data: An analysis of the FDA's own data on adverse events found 16 reported deaths linked to the toxin's spread. Four of those deaths were in children under the age of 18.
The Monkey Studies: Internal Allergan studies on laboratory monkeys revealed that when given a dose similar to or even less than what Jackson Wells received, half of the animals died. This suggests the company had preclinical data indicating a lethal risk at doses being used in children.
The Motive: A $50 Million Market and a Criminal Conviction
Why would such a high-risk practice continue? According to Allergan's own 2011 strategic sales plan, pediatric Botox was a $50-million-a-year market in the U.S.
The pursuit of this market led to one of the most damning moments in the product's history. In 2010, Allergan pleaded guilty to criminal charges of illegally marketing Botox for unapproved uses, including for children with cerebral palsy. They were forced to pay a $600 million fine for their actions.
This is not an allegation from a lawsuit; it is a criminal conviction. The company that makes Botox admitted in federal court to illegally promoting its neurotoxin for use in children.
A Betrayal of Trust
The use of this potent toxin in children is not a benign, risk-free therapy. It is a practice that is linked to child deaths and resulted in a criminal conviction for its manufacturer. Yet, as the 2023 neonatal study shows, it continues today.
Parents and caregivers must be empowered to question these treatments. They deserve to know the full history—the internal reports of pediatric deaths, the animal studies, and the manufacturer's criminal record. We must demand a higher standard of safety and full, transparent informed consent to protect our smallest and most vulnerable victims.
Sources
INVESTIGATION: What many don’t know about popular wrinkle drug. (KFOR News, 2013)
Use of botox for sialorrhea and dysphagia in the neonatal population. (Lu et al., American Journal of Otolaryngology, 2023)
BOTOX® (onabotulinumtoxinA) Prescribing Information. (Allergan, Inc.)
Serious and Long-Term Adverse Events Associated with the Therapeutic and Cosmetic Use of Botulinum Toxin. (Yiannakopoulou E., Pharmacology, 2015)
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