Botox Warnings

Distant Spread of Toxin Effect: Postmarketing safety data from BOTOX and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms that are consistent with the mechanism of action of botulinum toxin have been reported hours to weeks after injection, and may include muscular weakness, ptosis, diplopia, blurred vision, facial weakness, swallowing and speech disorders, constipation, aspiration pneumonia, difficulty breathing and respiratory depression. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in patients who have underlying conditions and comorbidities that would predispose them to these symptoms including adults treated for spasticity and other conditions, and are treated with high doses. Swallowing and breathing difficulties can be life threatening and death has been reported, although a definitive causal association to BOTOX has not been established.
General Warning and Precautions: The term "unit" upon which dosing is based, is a specific measurement of toxin activity that is unique to Allergan's formulation of botulinum toxin type A. Therefore, the "unit" used to describe BOTOX activity are different from those used to describe that of other botulinum toxin preparations and the units representing BOTOX activity are not interchangeable with other products.
BOTOX should only be given by physicians with the appropriate qualifications and experience in the treatment of patients and the use of required equipment. The relevant anatomy, and any alterations to the anatomy due to prior surgical procedures, must be understood prior to administering BOTOX and injection into vulnerable anatomic structures must be avoided.