What are the risks of BOTOX® injections for pain management?

Updated: Jun 19, 2018
  • Author: Anthony H Wheeler, MD; Chief Editor: Meda Raghavendra (Raghu), MD  more...
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Important safety information is included in a black box warning by Allergan regarding the distant spread of toxin effects. Postmarketing reports indicate that the effects of BOTOX® and all BTX products may spread from the area of injection and produce symptoms consistent with BTX effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Weakness of swallowing and breathing activities can be life threatening, and death has been reported.

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 who have underlying conditions that predispose them to these symptoms. In unapproved uses, including spasticity in children, and in some approved uses, cases of the distant spread of effect have been reported primarily at doses comparable to those used to treat cervical dystonia but also at lower doses of BOTOX®.

BOTOX® is contraindicated in the presence of infection at any proposed injection site and in individuals with a known hypersensitivity to any BTX preparation or to any of the components of the formulation. Warnings and precautions are important due to the lack interchangeability between BTX products. The potency units of BOTOX® are specific to the preparation and the the specific assay methods used. They are not interchangeable with other preparations of BTX products; therefore, units of biological activity of BOTOX® cannot be accurately compared with or converted into units of any other BTX product.

Physicians must be aware of the risk of a preexisting a neuromuscular disorder. Individuals with peripheral neuropathic motor disease, amyotrophic lateral sclerosis, or neuromuscular junction disorder (eg, myasthenia gravis, Lambert-Eaton syndrome) should be monitored particularly closely when given BTX. Patients with neuromuscular disorders may be at increased risk of clinically significant local or distant effects, including severe dysphagia and respiratory compromise from typical doses of BOTOX®.

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