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Adverse Clinical Effects of Botulinum Toxin Intramuscular Injections for Spasticity

  • Chetan P. Phadke (a1) (a2) (a3), Chitra K. Balasubramanian (a4), Alanna Holz (a1), Caitlin Davidson (a1), Farooq Ismail (a1) (a2) and Chris Boulias (a1) (a2)...

Objective: The adverse events (AEs) with botulinum toxin type-A (BoNTA), used for indications other than spasticity, are widely reported in the literature. However, the site, dose, and frequency of injections are different for spasticity when compared to the treatment for other conditions and hence the AEs may be different as well. The objective of this study was to summarize the AEs reported in Canada and systematically review the AEs with intramuscular botulinum toxin injections to treat focal spasticity. Methods : Data were gathered from Health Canada (2009-2013) and major electronic databases. Results : In a 4 year period, 285 AEs were reported. OnabotulinumtoxinA (n=272 events): 68% females, 53% serious, 18% hospitalization, and 8% fatalities. The type of AEs reported were – muscle weakness (19%), oropharyngeal (14%), respiratory (14%), eye related (8%), bowel/bladder related (8%), and infection (5%). IncobotulinumtoxinA (n=13): 38% females, 62% serious, and 54% hospitalization. The type of AEs reported were – muscle weakness (15%), oropharyngeal (15%), respiratory (38%), eye related (23%), bowel/bladder related (15%), and infection (15%). Commonly reported AEs in the literature were muscle weakness, pain, oropharyngeal, bowel/bladder, blood circulation, neurological, gait, and respiratory problems. Conclusion: While BoNTA is useful in managing spasticity, future studies need to investigate the factors that can minimize AEs. A better understanding of the underlying mechanisms of the AEs can also improve guidelines for BoNTA administration and enhance outcomes.

Réactions indésirables à des injections intramusculaires de toxine botulique utilisée pour traiter la spasticité. Objectif: Les réactions indésirables (RI) à la toxine botulique de type A (BoNTA) utilisée à des fins autres que le traitement de la spasticité ont été abondamment rapportées dans la littérature. Cependant, le point d’injection, la dose et la fréquence des injections sont différents quand elle est utilisée pour traiter la spasticité par rapport à son utilisation pour traiter d’autres affections et donc les RI peuvent également être différentes. Le but de cette étude était de présenter un sommaire des RI rapportées au Canada et de revoir systématiquement les RI rencontrées lors d’injections intramusculaires de toxine botulique pour traiter la spasticité focale. Méthode: Nous avons recueilli les données de Santé Canada de 2009 à 2013 et ainsi que celles des principales bases de données électroniques. Résultats: Au cours d’une période de 4 ans, 285 RI ont été rapportées, dont 272 RI avec l’onabotulinum toxine A. Soixante-huit pour cent sont survenues chez des femmes, 53% étaient des RI sérieuses, 18% ont nécessité une hospitalisation et 8% ont été fatales. Les RI rapportées étaient de la faiblesse musculaire (19%), des RI oropharyngées (14%), respiratoires (14%), oculaires (8%), en lien à l’intestin / la vessie (8%) et infectieuses (5%). Avec l’incobotulinum toxine A (n=13) les RI rapportées sont survenues chez des femmes dans 38% des cas, 62% étaient sérieuses et 54% ont nécessité une hospitalisation. Ces RI étaient de la faiblesse musculaire (15%), des troubles oropharyngés (15%), respiratoires (38%), en lien avec les yeux (23%), en lien avec l’intestin / la vessie (15%) et infectieuses (15%). Les RI fréquemment rapportées dans la littérature étaient la faiblesse musculaire, la douleur, des troubles oropharyngés, intestinaux / vésicaux, circulatoires, neurologiques, des troubles de la démarche et des troubles respiratoires. Conclusion: Bien que la BoNTA soit utile dans le traitement de la spasticité, des études méritent d’être entreprises pour identifier les facteurs qui pourraient minimiser les RI. Une meilleure compréhension des mécanismes sous-jacents est également susceptible d’améliorer les lignes directrices concernant l’administration de la BoNTA ainsi que les résultats de ce traitement.

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Corresponding author
Correspondence to: Chetan P. Phadke, Spasticity Research Program, West Park Healthcare Centre, Toronto, ON, Canada M6M 2J5. Email:
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