Real-world safety analysis of deutetrabenazine post-marketing: a disproportionality study leveraging the FDA Adverse Event Reporting System (FAERS) database DOI Creative Commons

Guangwei Qing,

S. Ye,

Bo Wei

et al.

BMC Pharmacology and Toxicology, Journal Year: 2025, Volume and Issue: 26(1)

Published: Feb. 21, 2025

Deutetrabenazine, a selective vesicular monoamine transporter type 2 (VMAT2) inhibitor, has been demonstrated efficacy in treating refractory neurologic disorders such as Tardive Dyskinesia (TD) and Huntington's disease but have potential adverse events (AEs) that require detailed pharmacovigilance. This study aimed to comprehensively assess the safety profile of deutetrabenazine real-world settings by analyzing AEs reported from FDA Adverse Event Reporting System (FAERS) database. We conducted retrospective pharmacovigilance using FAERS data Q3 2017 2024, focusing on deutetrabenazine-related AEs. applied four disproportionality analysis methods–Reporting Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) Multinomial Gamma Poisson Shrinkage (MGPS)--to identify signals. Furthermore, we utilized Weibull distribution model analyze temporal risk Among 10,571,578 reports obtained database, 4,337 AE were associated with deutetrabenazine. Using independent computational methods at preferred term (PT) level, identified 1,131 PTs indicated noteworthy reactions. The drug's label-listed reactions, including depression, somnolence, suicidal ideation, fatigue, showed remarkable detected reactions not specified label, drug ineffectiveness, dyskinesia, death, falls, insomnia. majority these within initial month treatment, median time onset 40.5 days. research yielded insights into practical use deutetrabenazine, validating established uncovering further possible risks. These findings present essential considerations for physicians when prescribing clinical treatment.

Language: Английский

Real-world safety analysis of deutetrabenazine post-marketing: a disproportionality study leveraging the FDA Adverse Event Reporting System (FAERS) database DOI Creative Commons

Guangwei Qing,

S. Ye,

Bo Wei

et al.

BMC Pharmacology and Toxicology, Journal Year: 2025, Volume and Issue: 26(1)

Published: Feb. 21, 2025

Deutetrabenazine, a selective vesicular monoamine transporter type 2 (VMAT2) inhibitor, has been demonstrated efficacy in treating refractory neurologic disorders such as Tardive Dyskinesia (TD) and Huntington's disease but have potential adverse events (AEs) that require detailed pharmacovigilance. This study aimed to comprehensively assess the safety profile of deutetrabenazine real-world settings by analyzing AEs reported from FDA Adverse Event Reporting System (FAERS) database. We conducted retrospective pharmacovigilance using FAERS data Q3 2017 2024, focusing on deutetrabenazine-related AEs. applied four disproportionality analysis methods–Reporting Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) Multinomial Gamma Poisson Shrinkage (MGPS)--to identify signals. Furthermore, we utilized Weibull distribution model analyze temporal risk Among 10,571,578 reports obtained database, 4,337 AE were associated with deutetrabenazine. Using independent computational methods at preferred term (PT) level, identified 1,131 PTs indicated noteworthy reactions. The drug's label-listed reactions, including depression, somnolence, suicidal ideation, fatigue, showed remarkable detected reactions not specified label, drug ineffectiveness, dyskinesia, death, falls, insomnia. majority these within initial month treatment, median time onset 40.5 days. research yielded insights into practical use deutetrabenazine, validating established uncovering further possible risks. These findings present essential considerations for physicians when prescribing clinical treatment.

Language: Английский

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