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Botulinum Toxins (OnabotulinumtoxinA, AbobotulinumtoxinA, IncobotulinumtoxinA, RimabotulinumtoxinB)

Distant Spread of Toxin Effect

  • The effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.
  • These symptoms may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties.
  • These symptoms have been reported hours to weeks after injection.
  • Swallowing and breathing difficulties can be life threatening and there have been reports of death.
  • The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
  • In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

FDA and Industry Communications

Information for Healthcare Professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc) (Aug 2009)

 

Medication Guides

AbobotulinumtoxinA (Dysport)

IncobotulinumtoxinA (Xeomin)

OnabotulinumtoxinA (Botox, Botox Cosmetic)

RimabotulinumtoxinB (Myobloc)

Package Inserts

Botox

Botox Cosmetic

Dysport

Myobloc

Additional Information

Updated January 2018