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Safety Analysis of OnabotulinumtoxinA
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  • Update Date: 16 Oct 2024
  • chronic migraine
  • cervical dystonia
  • multiple therapeutic indications
  • onabotulinumtoxinA
  • overactive bladder
  • safety
  • spasticity
  • treatment-emergent adverse event
Video Introduction

This video is adapted from 10.3390/toxins16100420

OnabotulinumtoxinA (onabotA) is approved in the US for 12 therapeutic indications. However, real-world data on the multi-indication use of onabotA are limited, often leading to delayed or reduced treatment. This study provides real-world evidence on the safety of onabotA when treating multiple indications concomitantly. SYNCHRONIZE was a multicenter, retrospective chart-review study evaluating the safety of onabotA for adults treated for two or more therapeutic indications within a three-month period. The primary outcome was treatment-emergent adverse events (TEAEs) within six months post-treatment. A total of 279 patients were included, with the most common concomitant indications being cervical dystonia and chronic migraine (43.4%). The average three-month cumulative dose for multiple indications was 282.2 U. Most patients (62.4%) had a treatment interval for multiple indications of 24 hours or less. Overall, 28.7% of patients reported one or more TEAEs, with no apparent trends related to TEAEs and dose interval or cumulative dose. Reported TEAEs included urinary tract infections (5.7%), neck pain (5.0%), and headache (4.3%). No patient experienced a lack of effect according to clinical objective measurements. SYNCHRONIZE described the real-world safety of onabotA for patients treated concomitantly for two or more indications within a three-month period. TEAEs were generally consistent with the known safety profiles of individual indications, and no new safety signals were identified.

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Forde, G.; Brucker, B.M.; Ifantides, K.B.; Patel, A.T.; Mayadev, A.; Brown, T.; Ayyoub, Z.; Martinez, K.; Singh, R.; Nelson, M.; et al. Safety Analysis of OnabotulinumtoxinA. Encyclopedia. Available online: https://encyclopedia.pub/video/video_detail/1389 (accessed on 18 January 2026).
Forde G, Brucker BM, Ifantides KB, Patel AT, Mayadev A, Brown T, et al. Safety Analysis of OnabotulinumtoxinA. Encyclopedia. Available at: https://encyclopedia.pub/video/video_detail/1389. Accessed January 18, 2026.
Forde, Grace, Benjamin M. Brucker, Kimberly Becker Ifantides, Atul T. Patel, Angeli Mayadev, Theodore Brown, Ziyad Ayyoub, Kenneth Martinez, Ritu Singh, Mariana Nelson, et al. "Safety Analysis of OnabotulinumtoxinA" Encyclopedia, https://encyclopedia.pub/video/video_detail/1389 (accessed January 18, 2026).
Forde, G., Brucker, B.M., Ifantides, K.B., Patel, A.T., Mayadev, A., Brown, T., Ayyoub, Z., Martinez, K., Singh, R., Nelson, M., Battucci, S., Yushmanova, I., Ukah, A., & Rhyne, C. (2024, October 15). Safety Analysis of OnabotulinumtoxinA. In Encyclopedia. https://encyclopedia.pub/video/video_detail/1389
Forde, Grace, et al. "Safety Analysis of OnabotulinumtoxinA." Encyclopedia. Web. 15 October, 2024.
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