A study on adverse events of botulinum toxin type A in real-world applications: A FAERS database analysis.

[AIMS] 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. BoNT-A-related AEs 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-Barré 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.