«Off-label» use of botulinic toxin type A preparations in neurological practice

Abstract

The modern view on the application of botulinum toxin type A for the off-label use in neurology and foreign experience analysis are presented. The «off-label» category referred to any prescription of a medication in case of using it for unregistered indications, with product instruction violation or in the presence of contraindications including age restrictions. The sources of information about medicines were the leaflets of manufacturers of medicines and the State Register of Medicines. It is well known that Botulinum toxin type A is a good therapeutic option for treating children with cerebral palsy. Increased efficacy of regularly repeated cycles with Onabotulinumtoxin A in medication-overuse headache patients beyond the first year of treatment. Botulinum toxin type A is effective in the management of sialorrhea. Botulinum toxin type A is a safe and effective treatment for primary axillary hyperhidrosis and produces high levels of patient satisfaction. Facing depression with botulinum toxin: positive effects on mood have been observed in subjects who underwent treatment of glabellar frown lines with botulinum toxin and, in an open case series, depression remitted or improved after such a treatment. Botox injection significantly improved foot dystonia, pain and lower limb functional outcomes in patients with Parkinson’s disease with deep brain stimulation. The paper describes the problems associated with the lack of clinical data about the possibility of using botulinum toxin type A in different conditions, emphasizes the need to organize clinical trials and educational programs for neurologists as well as more active implementation of protocols for the treatment of patients.