FDA Approvals and Consensus Guidelines for Botulinum Toxins in the Treatment of Dystonia

Toxins (Basel). 2020 May 17;12(5):332. doi: 10.3390/toxins12050332.

Abstract

In 2016, the American Academy of Neurology (AAN) published practice guidelines for botulinum toxin (BoNT) in the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. This article, focusing on dystonia, provides context for these guidelines through literature review. Studies that led to Food and Drug Administration (FDA) approval of each toxin for dystonia indications are reviewed, in addition to several studies highlighted by the AAN guidelines. The AAN guidelines for the use of BoNT in dystonia are compared with those of the European Federation of the Neurological Societies (EFNS), and common off-label uses for BoNT in dystonia are discussed. Toxins not currently FDA-approved for the treatment of dystonia are additionally reviewed. In the future, additional toxins may become FDA-approved for the treatment of dystonia given expanding research in this area.

Keywords: FDA; blepharospasm; botulinum toxin; cervical dystonia; dystonia.

Publication types

  • Review

MeSH terms

  • Acetylcholine Release Inhibitors / adverse effects
  • Acetylcholine Release Inhibitors / therapeutic use*
  • Botulinum Toxins / adverse effects
  • Botulinum Toxins / therapeutic use*
  • Consensus
  • Drug Approval*
  • Drug Compounding
  • Dystonia / drug therapy*
  • Humans
  • Off-Label Use
  • Practice Guidelines as Topic / standards*
  • United States
  • United States Food and Drug Administration / standards*

Substances

  • Acetylcholine Release Inhibitors
  • Botulinum Toxins