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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Clozapine Use and Risk of Infections in Patients with Schizophrenia: A Population-Based Cohort Study

Published: Jan. 1, 2025

Language: Английский

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Neuropsychiatric Burden of SARS-CoV-2: A Review of Its Physiopathology, Underlying Mechanisms, and Management Strategies

Viruses, Journal Year: 2024, Volume and Issue: 16(12), P. 1811 - 1811

Published: Nov. 21, 2024

The COVID-19 outbreak, caused by the SARS-CoV-2 virus, was linked to significant neurological and psychiatric manifestations. This review examines physiopathological mechanisms underlying these neuropsychiatric outcomes discusses current management strategies. Primarily a respiratory disease, frequently leads issues, including cephalalgia migraines, loss of sensory perception, cerebrovascular accidents, impairment such as encephalopathy. Lasting neuropsychological effects have also been recorded in individuals following infection. These include anxiety, depression, cognitive dysfunction, suggesting lasting impact on mental health. neuroinvasive potential inflammatory responses, role angiotensin-converting enzyme 2 (ACE2) neuroinflammation are critical factors In addition, highlights importance monitoring biomarkers assess Central Nervous System (CNS) involvement. Management strategies for conditions supportive therapy, antiepileptic drugs, antithrombotic psychotropic emphasizing need multidisciplinary approach. Understanding long-term implications is essential developing effective treatment protocols improving patient outcomes.

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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Antipsychotics and severity of infections: correlation or causation?

The Lancet Psychiatry, Journal Year: 2024, Volume and Issue: 11(10), P. 776 - 777

Published: Sept. 3, 2024

Language: Английский

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