José de León
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Establishing a Cardiac Implantable Electronic Device Lead Extraction Program in a Resource‐Limited Setting Open
Background The rising number of cardiac implantable electronic device (CIED) implantations in Asia is expected to increase CIED‐related infections and lead malfunctions. Establishing a lead extraction program is therefore essential. We des…
Potential Protective Role of Fiber Supplementation Against Depression: Insights from the National Health and Nutrition Examination Survey (NHANES) 2017–2018 Open
Depression is a multifaceted mental health disorder affecting 280 million people globally. The pursuit of effective interventions has triggered investigations into the role of fiber intake in modulating depression, which remains a controve…
Evaluation of physical activity among patients with cardiac implantable electronic devices in a philippine tertiary government hospital Open
Background Cardiac Implantable Electronic Devices (CIED), a treatment option for arrhythmia and heart failure, present physical challenges for patients after implantation. Assessing physical activity is crucial to determine appropriate rec…
The Relevance of Pharmacokinetic Biomarkers in Response to Methadone Treatment: A Systematic Review Open
Background/Objectives: Methadone maintenance treatment (MMT) is widely used in opioid use disorder (OUD). Its efficacy is influenced by its metabolism, primarily mediated by Cytochrome P450 (CYP450) enzymes in the liver. Genetic polymorphi…
View article: Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part II
Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part II Open
Purpose/Background This is the second part of a 2-part article that proposes improving the United States (US) clozapine package insert. Part II focuses on fatal outcomes and the 5 boxed warnings, 4 specifically for clozapine: severe neutro…
View article: Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I
Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I Open
Purpose/Background Clozapine was approved in the United States (US) using 1989 regulations and knowledge. After 30 years, many sections of the US package insert (PI) are outdated. Methods We comprehensively reviewed the literature to propo…
Reflections on the Potential and Risks of AI for Scientific Article Writing after the AI Endorsement by Some Scientific Publishers: Focusing on Scopus AI Open
The introduction of ChatGPT3 in 2023 disrupted the field of artificial intelligence (AI). ChatGPT uses large language models (LLMs) but has no access to copyrighted material including scientific articles and books. This review is limited b…
Severe necrotic colitis in an adolescent with polypharmacy and high clozapine doses according to his ancestry. Open
The antipsychotic drug Clozapine (CLZ) is approved for treat-ment-resistant schizophrenia and reduction in the risk of recurrent suicidal behavior in schizophrenia or schizoaffective disorder. However, it is increasingly used in psychiatry…
Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety Open
The spectrum of respiratory aspiration - aspiration pneumonia - pneumonia and other infections are significant causes of fatal outcomes in clozapine-treated patients. Clozapine had anti-suicidal effects versus other antipsychotics across a…
Clozapine may consistently protect from suicidal behaviors while other antipsychotics may lack a specific protective effect: a comprehensive VigiBase study interpreted in the context of the prior literature Open
This pharmacovigilance study, with all its inherent limitations, provides independent proof, not overlapping with prior literature, that clozapine may have specific strong anti-suicidal effects that do not appear to be present in other ant…
Proposing a novel approach for the long-term use of monthly paliperidone palmitate: adjusting injection dose versus adjusting injection interval Open
Keywords: antipsychotic agentsbipolar disorderdrug monitoringpaliperidone palmitatepharmacokineticspsychopharmacologyschizophrenia
A Systematic Review of Clozapine Concentration–Dose Ratio from Therapeutic Drug Monitoring Studies in Children and Adolescents Treated with Clozapine for Mental Disorders Open
Background: Therapeutic drug monitoring of clozapine in children and adolescents has received insufficient attention. Calculation of concentration-to-dose (C/D) ratios from trough steady-state concentrations estimate drug clearance. Method…
An expert review of clozapine in Latin American countries: Use, monitoring, and pharmacovigilance Open
There is growing interest in clozapine clinical use, monitoring, and research, particularly adverse drug reactions (ADRs) other than agranulocytosis. In this study we focused on clozapine pharmacovigilance. Hence, we contacted clinicians a…
Clozapine research standards in former USSR states: A systematic review of quality issues with recommendations for future harmonization with modern research standards Open
Clozapine papers in Russian language suffered from severe methodological drawbacks limiting generalizability. Changes regarding standardization, transparency, ethics, and good scientific practice are urgently required. Using reporting chec…
Adverse drug reactions and their fatal outcomes in clozapine patients in VigiBase: Comparing the top four reporting countries (US, UK, Canada and Australia) Open
The four countries appeared to report clozapine ADRs in different ways, making comparisons difficult. We estimated higher fatal outcomes in the UK and Canada after controlling for cross-sectional estimations of population and published clo…
Reflections on the Lack of Consideration of Ethnic Ancestry to Stratify Clozapine Dosing Open
This review article argues against trusting standard clozapine references, including the US package insert, because they do not include advances in the sciences of pharmacokinetics and pharmacovigilance and ignore the effects of ethnic anc…
Positive and Negative Syndrome Scale (PANSS) predictors of hospitalization during home treatment on 1045 patients with schizophrenia in acute crisis Open
Introduction Several factors related to the risk of requiring psychiatric hospitalization have been described in patients diagnosed with schizophrenia treated with methods other than home treatment. With regard to the symptoms, high global…
Respiratory aspiration during treatment with clozapine and other antipsychotics: a literature search and a pharmacovigilance study in vigibase Open
Antipsychotics (APs), during treatment or overdose, may be associated with respiratory aspiration. A PubMed search on 30 September 2022, provided 3 cases of respiratory aspiration during clozapine therapy and 1 case during an AP overdose. …
Japanese patients need slower, personalized clozapine titrations: A comment on the case described by Kikuchi et al. Open
Kikuchi et al. published an extremely illustrative clozapine case.1 A 43-year-old nonsmoking male Japanese patient was started on 12.5 mg/day of clozapine and up-titrated to 150 mg/day on day 15. A fever on day 17 led to suspicion of pneum…
New international guideline for clozapine titration based on ethnic origin, CRP value and clozapine serum concentration Open
AMA Wilkowska A, Jerzy Cubała W, de Leon J. New international guideline for clozapine titration based on ethnic origin, CRP value and clozapine serum concentration. Psychiatria Spersonalizowana. 2023;2(2):41-45. doi:10.5114/psychs.2023.127…
Clozapine-induced myocarditis in children and adolescents: a pharmacovigilance study using VigiBase and a systematic literature review Open
Clozapine-induced myocarditis in children (age ≤18 yo) was studied from a PubMed search (18 July 2022) (9 cases) and from the World Health Organization’s pharmacovigilance database, called Vigibase, of adverse drug reaction (ADR) reports (…
REFLECTIONS ON THE COMPLEX HISTORY OF THE CONCEPT OF CLOZAPINE-INDUCED INFLAMMATION DURING TITRATION Open
Clozapine was synthesized in 1958. The Food and Drug Administration approved it in 1989 when comprehensive pharmacokinetic studies were not required and it was not known that clozapine was metabolized by the cytochrome P450 1A2 (CYP1A2). C…
According to the WHO clozapine pharmacovigilance database, the United Kingdom accounts for 968 fatal outcomes versus 892 in the rest of the world Open
National drug agencies send reports of adverse drug reactions (ADRs) to the World Health Organization's (WHO) pharmacovigilance database, used by Montastruc et al.1 for an extremely important contribution regarding fatal outcomes of clozap…