FDA Checks Reports of Botox Risks

The FDA today announced that it's investigating rare reports of serious adverse events linked with Botox, Botox Cosmetic, and Myobloc.

The most serious cases, in which patients died or were hospitalized, occurred in children with cerebral palsy who got botulinum toxin for severe arm and leg muscle spasms associated with their cerebral palsy. That's an unapproved use of the drugs.

No adult deaths have been linked to the drugs, but some adults have been hospitalized, including at least one person who used Botox for cosmetic uses. It's not clear if that case was due to Botox use. Adults' reported symptoms include difficulty holding up their heads, weakness, difficulty swallowing, and droopy eyelids.

The FDA isn't halting the drugs, but it is reviewing the products' labels.

The FDA advises patients and caregivers to watch for possible side effects including weakness, difficulty breathing, difficulty swallowing, and change in voice. Those effects have been reported as early as one day and as late as several weeks after treatment.