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 ...