Evaluation of atypical antipsychotics associated rhabdomyolysis using the FDA adverse event reporting system database

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: March 26, 2025

Rhabdomyolysis is a potentially fatal adverse reaction mainly caused by certain medications. Few real-world studies have shown clear association between atypical antipsychotics and rhabdomyolysis. This study aimed to evaluate the rhabdomyolysis using FDA Adverse Event Report System (FAERS) database. The data were obtained from FAERS database January 1, 2004 December 31, 2023. To identify potential risk signals database, disproportionality analysis was conducted reporting odds ratio (ROR) corresponding 95% confidence intervals (CIs) with p-values adjusted via Bonferroni correction. time onset, hospitalization rate, mortality of associated also investigated. A total 2360 case reports considered. Quetiapine had greatest proportion (27.75%). Olanzapine highest positive signal values Statistically significant RORs (95% CI) for (in descending order): olanzapine 4.02 (3.72–4.35), quetiapine 3.81 (0.53–27.6), ziprasidone 2.76 (2.19–3.49), risperidone 2.12 (1.91–2.35), aripiprazole 2 (1.8–2.21), clozapine 1.47 (1.31–1.64). In onset analysis, all early failure type characteristics, occurrence would be gradually decreased over time. Our highlights importance vigilant patient monitoring following prescription reduce It necessary monitor serum creatinine kinase (CK) level early, especially during dose adjustment or initiation new antipsychotics. research may provide valuable information patients, clinicians, others concerned safety antipsychotics, optimize clinical practice.

Language: Английский

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Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part II

Journal of Clinical Psychopharmacology, Journal Year: 2025, Volume and Issue: unknown

Published: April 8, 2025

Abstract Purpose/Background This is the second part of a 2-part article that proposes improving United States (US) clozapine package insert. Part II focuses on fatal outcomes and 5 boxed warnings, 4 specifically for clozapine: severe neutropenia, seizure, orthostatic hypotension myocarditis, 1 all antipsychotics (elderly with dementia). Methods US reports to World Health Organization's global pharmacovigilance database were analyzed from clozapine's introduction January 15, 2023. Findings/Results The was top reporter worldwide 56,003 9587 associated outcomes. warnings 534 (218 131 seizures, 125 orthostasis, 36 24 cardiomyopathy, 0 mitral valve prolapse). With no pneumonia 674 increased white blood cell count (a sign infection) 596 After considering overlaps, increases in explained 900 fatalities, or 9.4% Food Drug Administration continues focus neutropenia which only 218 2.3% outcomes, whereas 97.7% reported clozapine-treated patients had another cause. Implications/Conclusions To help prevent future deaths patients, insert should during infections. offers detailed solutions regarding current lack warning other Supplementary Material includes letters support 124 non-US experts 44 countries/regions who Parts I II.

Language: Английский

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Global and regional estimates of vaccine-associated herpes zoster and their related vaccines from 1969 to 2023

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: April 17, 2025

Abstract Vaccine-induced immunosuppression can reactivate the varicella-zoster virus, potentially leading to development of herpes zoster. However, literature on this topic is inconsistent, resulting in limited clarity. Therefore, we aimed enhance our understanding vaccine-associated zoster and establish guidelines for future research, utilizing a global database improve public health. We investigated adverse events using reports (~ 13 million reports) from WHO international pharmacovigilance database. Data were analyzed number reports, reported odds ratios (ROR), information components (IC) determine potential association between 18 vaccines nearly 170 countries territories 1969 2023. Of 7,805,380 events, there 51,985 reports. Vaccine-associated showed highest strength with COVID-19 mRNA (ROR, 11.85 [95% CI, 11.70-12.01]; IC, 2.74 [IC 0.25 , 2.72]), followed by encephalitis 4.07 3.37–4.92]; 2.00 1.68]), influenza 3.44 3.28–3.62]; 1.77 1.69]), ad5-vectored 3.05 2.97–3.14]; 1.54 1.50]). The ROR IC males 7.94 7.80–8.08]; 2.47 2.45]) females 6.71 6.62–6.80]; 2.30 2.28]). increased advancing age. Our findings emphasize need consider immune status vaccine recipients implement appropriate compensation management manuals

Language: Английский

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Evaluating the adverse drug reactions to clozapine in populations of children and adolescents: insights from VigiBase data

European Child & Adolescent Psychiatry, Journal Year: 2024, Volume and Issue: unknown

Published: Dec. 2, 2024

Language: Английский

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