The FDA announced yesterday that it will require new warnings for Botox and all other Botulinum Toxin products. Botulinum toxin is a neurotoxic protein produced by the bacterium Clostriduam botulinum. It is the most toxic protein known to scientists and one of the most lethal substances to occur in nature. Although not approved for such use, it is often prescribed to children with cerebral palsy, who are injected with the drug in an effort to control limb spasticity that is associated with the disorder. The drug works by paralyzing the muscles, which restricts unwanted movement. After injection, however, the toxin can migrate to other areas of the body, including those muscles used to breathe, causing potentially deadly paralysis. The FDA stated that this adverse affect has occurred most frequently in children with cerebral palsy and that several children with the birth injury have died as a result of the treatment.
The new label requirement includes a black box warning, a type of warning that is reserved for drugs with significant risks of serious or life-threatening adverse affects.
For more information on the FDA’s Botox warning, click here.