Dysport

The FDA has announced that it will require a “Black Box” warning on Botox and its competitors due to serious adverse side-effects.  Many of the side-effects have been reported when Botox has been used as an off-label treatment for children with cerebral palsy.  Side-effects in children have included difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression.  Serious case reports described hospitalizations involving ventilatory support and reports of death.  The majority of the adult postmarketing case reports occurred following use of botulinum toxin for the treatment of spasticity (an unapproved use) or cervical dystonia.  Some cases resulted in hospitalization, including several cases that required placement of a gastric tube or mechanical ventilation.

Tagged as: Black Box warning, Botox, drug, drug side-effects, Dysport, FDA, Myobloc

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