Low Prevalence of Botulinum Toxin-A Adverse Effects: Good Safety Profile or Underreporting?

O.Aimer*, N.Roche, H.Michelon, A.Schnitzler, K.Hamami, L.Fellous, F.Genet, M.Villart,

Introduction: The incidence of botulinum toxin type A (BoNT-A) injections related adverse effects (AE) is relatively high in literature. Many of injections are carried out yearly in our Physical and Rehabilitation Medicine (PRM) unit, however only 4 adverse effects have been reported since 2010. 

The aim of this single-center prospective observational study was to determine the reasons to explain the large difference in the prevalence of AE reported in the literature and in our PRM unit, and to take measures to improve AE reporting. 

Method: Patients suffering from limb spasticity were monitored between May and August 2015. Four to six weeks after intramuscular BoNT-A injection, patients were contacted by a pharmacist and questioned about any AE experienced. A survey was also performed to explore the reporting of adverse effects among the physicians injecting BoNT-A. 

Results: Twenty-seven patients were included in the study. Thirteen patients (44%) reported 23 AE that occurred between 4 and 6 weeks after injection. Two of them were major effects and all resolved spontaneously. Physicians reported having noted AE following BoNT-A injection in the medical files, without declaring them. 

Conclusion: The results of this study confirm that BoNT-A related AE are under-reported. Information and training are required to raise physician awareness and increase AE reporting. This will improve management of its tolerance and efficacy. 

Keywords:

Published on: Nov 10, 2017 Pages: 90-93

Full Text PDF Full Text HTML DOI: 10.17352/2455-5487.000055
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