A Study on Adverse Events of Botulinum toxin type A in Real-World Applications: A FAERS Database Analysis

BACKGROUND: Botulinum toxin type A (BoNT-A) is widely used for its efficacy in treating a variety of neuromuscular disorders. However, data on its safety and adverse events (AEs) in real-world settings remain limited. The Food and Drug Administration Adverse Event Reporting System (FAERS) database provides an invaluable resource for evaluating the safety of BoNT-A. METHODS: We used four methods to evaluate the disproportionality of AEs associated with BoNT-A: the Reporting Odds Ratio (ROR), the Proportional Reporting Ratio (PRR), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-item Gamma Poisson Shrinker (MGPS). RESULTS: Among the 17,307,196 case reports in the FAERS database, there were 69,644 reports where BoNT-A was listed as the ”Primary Suspect” for AEs. AEs caused by BoNT-A affected 27 system organ classes (SOCs). Based on the four algorithms, 290 significant disproportionalities at the Preferred Term (PT) level were retained. Unexpected AEs such as skin wrinkles, hyperacusis, Guillain-Barre syndrome, mediastinitis, and infective aneurysm were identified, which are not mentioned in the product insert. CONCLUSION: This study provides an overview of AEs in the real-world use of BoNT-A, revealing its broad safety profile. Although the majority of AEs were mild to moderate, there is a need to remain vigilant for serious AEs and to monitor them in clinical practice.