Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of MYOBLOC and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These 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 occurred at doses comparable to those used to treat cervical dystonia and at lower doses.
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NEWS HIGHLIGHTS
Published Studies Related to Myobloc (Rimabotulinumtoxinb)
RimabotulinumtoxinB effects on pain associated with cervical dystonia: results of
placebo and comparator-controlled studies. [2010]
Response rate (RR) and mean improvement (MI) in the pain subscale of the Toronto
Western Spasmodic Torticollis Rating Scale (TWSTRS-PS) from two
placebo-controlled studies and one comparator-controlled study were evaluated to
examine the effect of rimabotulinumtoxinB (BoNT-B) on cervical dystonia (CD)
pain...
Pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for
treatment of axillary hyperhidrosis. [2005]
(botulinum toxin type B) in the treatment of bilateral axillary hyperhidrosis... CONCLUSION: Myobloc (botulinum toxin type B) proved to be safe and efficacious
Double-blind, randomized, placebo-controlled pilot study of the safety and
efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar
hyperhidrosis. [2005]
placebo-controlled study to report on the safety and efficacy of Myobloc... CONCLUSION: Myobloc proved to be efficacious for the treatment of palmar
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