Pulmonary Embolism in a Patient With ADPKD Treated With Tolvaptan: From the Clinical Experience to the Analysis of the Food and Drug Administration Adverse Event Reporting System Registry

Aiello, Valeria; Fusaroli, Michele; Raschi, Emanuel; Palazzini, Massimiliano; Hu, Lilio; Barbuto, Simona; Poluzzi, Elisabetta; Capelli, Irene

doi:10.1016/j.ekir.2021.06.028

Cited by 3 publications

(2 citation statements)

References 11 publications

(9 reference statements)

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“…Traditional disproportionality analyses focus on at most a handful of drugs and/or adverse events 43,44 . Thus, they can provide a fine-grained analysis of potential confounders, including a nuanced analysis of how sociodemographic variables might affect drug prescription and adverse reactions 45 .…”

Section: Large-scale Analysesmentioning

confidence: 99%

Identifying Medications Underlying Communication Atypicalities in Psychotic and Affective Disorders: A Pharmacovigilance Study Within the FDA Adverse Event Reporting System

Fusaroli,

Simonsen,

Borrie

et al. 2023

J Speech Lang Hear Res

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Purpose: Communication atypicalities are considered promising markers of a broad range of clinical conditions. However, little is known about the mechanisms and confounders underlying them. Medications might have a crucial, relatively unknown role both as potential confounders and offering an insight on the mechanisms at work. The integration of regulatory documents with disproportionality analyses provides a more comprehensive picture to account for in future investigations of communication-related markers. The aim of this study was to identify a list of drugs potentially associated with communicative atypicalities within psychotic and affective disorders. Method: We developed a query using the Medical Dictionary for Regulatory Activities to search for communicative atypicalities within the FDA Adverse Event Reporting System (updated June 2021). A Bonferroni-corrected disproportionality analysis (reporting odds ratio) was separately performed on spontaneous reports involving psychotic, affective, and non-neuropsychiatric disorders, to account for the confounding role of different underlying conditions. Drug–adverse event associations not already reported in the Side Effect Resource database of labeled adverse drug reactions (unexpected) were subjected to further robustness analyses to account for expected biases. Results: A list of 291 expected and 91 unexpected potential confounding medications was identified, including drugs that may irritate (inhalants) or desiccate (anticholinergics) the larynx, impair speech motor control (antipsychotics), or induce nodules (acitretin) or necrosis (vascular endothelial growth factor receptor inhibitors) on vocal cords; sedatives and stimulants; neurotoxic agents (anti-infectives); and agents acting on neurotransmitter pathways (dopamine agonists). Conclusions: We provide a list of medications to account for in future studies of communication-related markers in affective and psychotic disorders. The current test case illustrates rigorous procedures for digital phenotyping, and the methodological tools implemented for large-scale disproportionality analyses can be considered a road map for investigations of communication-related markers in other clinical populations. Supplemental Material: https://doi.org/10.23641/asha.23721345

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Section: Large-scale Analysesmentioning

confidence: 99%

Identifying Medications Underlying Communication Atypicalities in Psychotic and Affective Disorders: A Pharmacovigilance Study Within the FDA Adverse Event Reporting System

Fusaroli,

Simonsen,

Borrie

et al. 2023

J Speech Lang Hear Res

Self Cite

View full text Add to dashboard Cite

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“…Traditional pharmacosurveillance studies focus on at most a handful of drugs and/or adverse events 43,44 . Thus, they can provide a fine-grained analysis of potential confounders, including a nuanced analysis of how sociodemographic variables might affect drug prescription and adverse reactions 45 .…”

Section: Large-scale Analysesmentioning

confidence: 99%

Identifying medications underlying communication atypicalities in psychotic and affective disorders: A pharmacovigilance study within the FDA Adverse Event Reporting System

Fusaroli

Simonsen

Borrie

et al. 2022

Preprint

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Background: Disruptions in language and speech are considered promising markers of affective and psychotic disorders. However, little is known about the mechanisms and confounders underlying such communicative atypicalities. Medications might have a crucial, relatively unknown role both as potential confounders and relatedly offering an insight about the mechanisms at work. The integration of regulatory documents with pharmacovigilance techniques could provide a more comprehensive picture to account for in future investigations of communication-related biomarkers. Objectives: Our aim was to identify a list of drugs potentially associated with speech and language atypicalities within psychotic and affective disorders. Methods: To structure a search for potential drug-induced communicative atypicalities on the FDA Adverse Event Reporting System (FAERS, updated June 2021), we developed a query using the Medical Dictionary for Regulatory Activities (MedDRA). We performed a Bonferroni corrected disproportionality analysis (Reporting Odds Ratio) on three separate populations: psychotic, affective, and non-neuropsychiatric disorders, to account for the confounding role of different underlying conditions. Unexpected drug adverse event associations, which were not already reported in the SIDER database of labeled adverse drug reactions, were subjected to further robustness analyzes to account for expected biases. Results: We identified a list of 291 expected and 91 unexpected potential confounding medications. We corroborated known/suspected associations: e.g., corticosteroids-related dysphonia and immunosuppressant-related stuttering. We also identified novel signals: e.g., domperidone-associated aphasia or VEGFR inhibitors-related dysphonia. Conclusions: We provide a list of medications to account for in future studies of communication-related biomarkers in affective and psychotic disorders. The methodological tools here implemented for large scale pharmacosurveillance investigations will facilitate future investigations of communication-related biomarkers in other conditions and provide a case study in more rigorous procedures for digital phenotyping in general. Objectives: Our aim was to identify a list of drugs potentially associated with speech and language atypicalities within psychotic and affective disorders, to account for in future investigations of communicative markers and to provide tools for similar future endeavors. Methods: We identified terms from the Medical Dictionary for Regulatory Activities (MedDRA) related to speech and language adverse drug reactions and clustered them by partial semantic overlap to structure a search on the FDA Adverse Event Reporting System (FAERS, updated June 2021). A Bonferroni corrected disproportionality analysis was applied to three separate populations in the FAERS: psychotic, affective, and non-neuropsychiatric disorders, to account for the confounding role of different underlying conditions. Unexpected drug adverse event associations, which were not already reported in the SIDER database of labeled adverse drug reactions, were subjected to further robustness analyzes to account for expected biases. Results: We identified a list of 291 expected and 91 unexpected potential confounding medications. We also developed methodological tools for large-scale pharmacosurveillance investigations: a MedDRA query proposal for speech and language impairments, formalization of possible biases, and related analyzes to account for them. Conclusions: We provide a list of medications to account for in future studies of communicative behavioral biomarkers in affective and psychotic disorders. The developed methodological tools will facilitate future investigations of communicative biomarkers in other conditions and provide a case study in more rigorous procedures for digital phenotyping in general.

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Liver Injury with Nintedanib: A Pharmacovigilance–Pharmacokinetic Appraisal

et al. 2022

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Drug-induced liver injury (DILI) with nintedanib has emerged as an adverse event of special interest in premarketing clinical trials. We characterized DILI with nintedanib in the real world and explored the underlying pharmacological basis. First, we assessed serious hepatic events reported to the Food and Drug Administration’s Adverse Event Reporting System by combining the disproportionality approach [reporting odds ratio (ROR) with 95% confidence interval (CI)] with individual case assessment. Demographic and clinical features were inspected (seriousness, onset, discontinuation, dechallenge/rechallenge, concomitant drugs) to implement an ad hoc causality assessment scoring system. Second, we appraised physiochemical and pharmacokinetic parameters possibly predictive of DILI occurrence. Significant disproportionality was found for nintedanib as compared to pirfenidone (N = 91; ROR = 4.77; 95% CI = 3.15–7.39). Asian population, low body weight (59 kg), and rapid DILI onset (13.5 days) emerged as clinical features. Hospitalization and discontinuation were found in a significant proportion of cases (32% and 36%, respectively). In 24% of the cases, at least two potentially hepatotoxic drugs (statins, proton pump inhibitors, antibiotics) were recorded. Causality was at least possible in 92.3% of the cases. High lipophilicity and predicted in silico inhibition of liver transporters emerged as potential pharmacokinetic features supporting the biological plausibility. Although causality cannot be demonstrated, clinicians should consider early monitoring and medication review on a case-by-case basis.

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Pulmonary Embolism in a Patient With ADPKD Treated With Tolvaptan: From the Clinical Experience to the Analysis of the Food and Drug Administration Adverse Event Reporting System Registry

Cited by 3 publications

References 11 publications

Identifying Medications Underlying Communication Atypicalities in Psychotic and Affective Disorders: A Pharmacovigilance Study Within the FDA Adverse Event Reporting System

Identifying Medications Underlying Communication Atypicalities in Psychotic and Affective Disorders: A Pharmacovigilance Study Within the FDA Adverse Event Reporting System

Identifying medications underlying communication atypicalities in psychotic and affective disorders: A pharmacovigilance study within the FDA Adverse Event Reporting System

Liver Injury with Nintedanib: A Pharmacovigilance–Pharmacokinetic Appraisal

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