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Public Citizen urged the FDA to investigate certain rare cases where the botulinum toxin may have spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, which could be potentially fatal. After investigating these cases, the FDA found that these adverse events occurred primarily in pediatric populations after high dose injections to treat muscle spasticity due to cerebral palsy, and in adult populations being treated for spasticity or cervical dystonia. It is important to realize that none of these events occurred as a result of the much lower doses of botulinum toxin injected for cosmetic reasons, or the slightly higher doses injected into the underarms for excessive sweating.

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