Key result
Guanfacine exposure was associated with 158 significant adverse event terms, including unexpected signals such as homicidal ideation, self-injurious ideation, and growth failure.
Why the study?
The study aimed to evaluate real-world Guanfacine-associated adverse events using FAERS data mining to provide a safety profile and guidance for therapeutic practice.
What are the real-world adverse events associated with Guanfacine reported in the FAERS database?
Observational (n=2,709)
What are the real-world adverse events associated with Guanfacine reported in the FAERS database?
Answers are grounded in this paper and cite their sources.
Real-world pharmacovigilance data mining identified novel and unexpected adverse event signals for Guanfacine, including homicidal ideation and growth failure, which may guide safer therapeutic practices.
OBJECTIVE: This study aims to evaluate the Guanfacine-associated adverse events (AEs) in real-world using data mining in FAERS database, seeking to provide safety profile and guidance for the potential therapeutic practices. METHODS: We retrospectively extracted Guanfacine-associated AEs reports in the FAERS database from the first quarter of 2004 (Q1) to the fourth quarter of 2023 (Q4). All data were strictly collected and comprehensively analyzed. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM). RESULTS: Out of 16,985,532 reports collected from the FAERS database, 2,709 reports of Guanfacine as the 'primary suspected (PS)' and 8,464 AEs induced by Guanfacine were identified. Most AEs reports (67.45%) occurred within the first 30 days of treatment (excluding unreported or unknown onset time reports). A total of 158 significant PTs that meet all four algorithms were detected. Known neuropsychiatric events and cardiovascular events documented in the drug's leaflet were found. Besides, unexpected significant AEs such as homicidal ideation, self-injurious ideation, growth failure, excessive eye blinking were also found. CONCLUSION: Our study has unveiled novel Guanfacine-associated AEs signals and might provide guidance for its rational use.
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Chen et al. (2024) conducted an observational in Guanfacine-associated adverse events (n=2,709). Guanfacine was evaluated on Significant adverse event signals (Preferred Terms). Guanfacine exposure was associated with 158 significant adverse event terms, including unexpected signals such as homicidal ideation, self-injurious ideation, and growth failure.
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