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  1. Article ; Online: Interpretation of Pharmacovigilance Disproportionality Analyses.

    Khouri, Charles / Fusaroli, Michele / Salvo, Francesco / Raschi, Emanuel

    Clinical pharmacology and therapeutics

    2023  Volume 114, Issue 4, Page(s) 745–746

    MeSH term(s) Humans ; Pharmacovigilance ; Adverse Drug Reaction Reporting Systems ; Databases, Factual
    Language English
    Publishing date 2023-05-30
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.2951
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach.

    Giunchi, Valentina / Fusaroli, Michele / Hauben, Manfred / Raschi, Emanuel / Poluzzi, Elisabetta

    Drug safety

    2023  Volume 46, Issue 10, Page(s) 921–926

    MeSH term(s) Humans ; United States ; Adverse Drug Reaction Reporting Systems ; United States Food and Drug Administration
    Language English
    Publishing date 2023-08-31
    Publishing country New Zealand
    Document type Editorial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-023-01345-w
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  3. Article ; Online: Transparency and robustness of safety signals.

    Khouri, Charles / Fusaroli, Michele / Salvo, Francesco / Raschi, Emanuel

    BMJ (Clinical research ed.)

    2022  Volume 379, Page(s) o2588

    MeSH term(s) Humans ; Data Collection
    Language English
    Publishing date 2022-11-03
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 1362901-3
    ISSN 1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    ISSN (online) 1756-1833
    ISSN 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
    DOI 10.1136/bmj.o2588
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Behavioral excess and disruptive conduct: A historical and taxonomic approach to the origin of the 'impulse control disorders' diagnostic construct.

    Fusaroli, Michele / Pellegrini, Luca / Fusaroli, Riccardo / Raschi, Emanuel / Menchetti, Marco / Poluzzi, Elisabetta

    Addiction (Abingdon, England)

    2022  Volume 118, Issue 4, Page(s) 763–770

    Abstract: Aims: Impulse control disorders (ICDs) are iatrogenic and idiopathic conditions with psychosocial and economic consequences for the affected individuals and their families (e.g. bankruptcy and divorce). However, the definition of ICDs has changed over ... ...

    Abstract Aims: Impulse control disorders (ICDs) are iatrogenic and idiopathic conditions with psychosocial and economic consequences for the affected individuals and their families (e.g. bankruptcy and divorce). However, the definition of ICDs has changed over time, and ICDs are not consistently included within existing taxonomies. We discuss the origins of the ICD diagnostic construct and its unsolved tensions.
    Methods: To contextualize the ICD diagnostic construct, we provided an overview of its origins in past centuries and followed its development across multiple editions of the Diagnostic and Statistical Manual and the International Classification of Diseases, as well as its definition within emerging ontologies.
    Results: Two independent roots of the ICD construct emerged: (a) the interest in behavioral excess as expressed in encyclopedic compilations (18th century) and (b) the juridical debate on disruptive conduct and responsibility (19th-20th centuries). These roots underlie the repeated taxonomic remodeling observed throughout the 20th and 21st centuries and three critical issues persisting in both clinical practice and research. First, the number of ICDs keeps increasing across the spectrum of human behaviors, disregarding common pathogenetic and phenomenological grounds. Secondly, ICDs substantially overlap with other mental conditions. Impulsivity is often neglected as a minor inconvenience or side effect when co-occurring with major diagnoses (e.g. depression) and therefore inadequately managed. Finally, ICDs' definitions display an unsolved tension between being conceived as hobby, moral fault or pathological drive, which may be responsible for stigma and delayed intervention.
    Conclusion: The reasons that made impulse control disorders (ICDs) difficult to define from their first conceptualization are the same reasons that now complicate taxonomic efforts and diagnosis. Tracing back ICDs' roots and criticalities can help to define a common and less ambiguous theoretical framework, which may also result in the demise of the ICD construct and a move towards more clearly defined and more useful ontologies.
    MeSH term(s) Humans ; Comorbidity ; Disruptive, Impulse Control, and Conduct Disorders/diagnosis ; Impulsive Behavior ; International Classification of Diseases ; Diagnostic and Statistical Manual of Mental Disorders
    Language English
    Publishing date 2022-12-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 1141051-6
    ISSN 1360-0443 ; 0965-2140
    ISSN (online) 1360-0443
    ISSN 0965-2140
    DOI 10.1111/add.16086
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  5. Article ; Online: Identifying Medications Underlying Communication Atypicalities in Psychotic and Affective Disorders: A Pharmacovigilance Study Within the FDA Adverse Event Reporting System.

    Fusaroli, Michele / Simonsen, Arndis / Borrie, Stephanie A / Low, Daniel M / Parola, Alberto / Raschi, Emanuel / Poluzzi, Elisabetta / Fusaroli, Riccardo

    Journal of speech, language, and hearing research : JSLHR

    2023  Volume 66, Issue 9, Page(s) 3242–3259

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) United States ; Humans ; Pharmacovigilance ; Adverse Drug Reaction Reporting Systems ; Vascular Endothelial Growth Factor A ; United States Food and Drug Administration ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Databases, Factual ; Mood Disorders ; Communication
    Chemical Substances Vascular Endothelial Growth Factor A
    Language English
    Publishing date 2023-07-31
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1364086-0
    ISSN 1558-9102 ; 1092-4388
    ISSN (online) 1558-9102
    ISSN 1092-4388
    DOI 10.1044/2023_JSLHR-22-00739
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    Zs.A 606: Show issues Location:
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  6. Article ; Online: Authors' Reply to Robert P. Giugliano and Colleagues' Comment on: "Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance".

    Raschi, Emanuel / Fusaroli, Michele / Diemberger, Igor / Poluzzi, Elisabetta

    Drug safety

    2021  Volume 44, Issue 4, Page(s) 505–506

    MeSH term(s) Anticoagulants/adverse effects ; Humans ; Lung Diseases, Interstitial/chemically induced ; Pharmacovigilance
    Chemical Substances Anticoagulants
    Language English
    Publishing date 2021-02-24
    Publishing country New Zealand
    Document type Letter ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-021-01054-2
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  7. Article ; Online: Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS.

    Fusaroli, Michele / Giunchi, Valentina / Battini, Vera / Puligheddu, Stefano / Khouri, Charles / Carnovale, Carla / Raschi, Emanuel / Poluzzi, Elisabetta

    Drug safety

    2024  Volume 47, Issue 3, Page(s) 271–284

    Abstract: Introduction: In refining drug safety signals, defining the object of study is crucial. While research has explored the effect of different event definitions, drug definition is often overlooked. The US FDA Adverse Event Reporting System (FAERS) records ...

    Abstract Introduction: In refining drug safety signals, defining the object of study is crucial. While research has explored the effect of different event definitions, drug definition is often overlooked. The US FDA Adverse Event Reporting System (FAERS) records drug names as free text, necessitating mapping to active ingredients. Although pre-mapped databases exist, the subjectivity and lack of transparency of the mapping process lead to a loss of control over the object of study.
    Objective: We implemented the DiAna dictionary, systematically mapping individual free-text instances to their corresponding active ingredients and linking them to the World Health Organization Anatomical Therapeutic Chemical (WHO-ATC) classification.
    Methods: We retrieved all drug names reported to the FAERS (2004-December 2022). Using existing vocabularies and string editing, we automatically mapped free text to ingredients. We manually revised the mapping and linked it to the ATC classification.
    Results: We retrieved 18,151,842 reports, with 74,143,411 drug entries. We manually checked the first 14,832 terms, up to terms occurring over 200 times (96.88% of total drug entries), to 6282 unique active ingredients. Automatic unchecked translations extend the standardization to 346,854 terms (98.94%). The DiAna dictionary showed a higher sensitivity compared with RxNorm alone, particularly for specific drugs (e.g., rimegepant, adapalene, drospirenone, umeclidinium). The most prominent drug classes in the FAERS were immunomodulating (37.40%) and neurologic drugs (29.19%).
    Conclusion: The DiAna dictionary, as a dynamic open-source tool, provides transparency and flexibility, enabling researchers to actively shape drug definitions during the mapping phase. This empowerment enhances accuracy, reproducibility, and interpretability of results.
    MeSH term(s) United States ; Humans ; Adverse Drug Reaction Reporting Systems ; Drug-Related Side Effects and Adverse Reactions ; Reproducibility of Results ; Software ; United States Food and Drug Administration
    Language English
    Publishing date 2024-01-04
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-023-01391-4
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  8. Article ; Online: Authors' Reply to Cappello et al. Comment on: "Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System".

    Fusaroli, Michele / Pelletti, Guido / Giunchi, Valentina / Raschi, Emanuel / De Ponti, Fabrizio / Pelotti, Susi / Poluzzi, Elisabetta

    Drug safety

    2023  Volume 46, Issue 9, Page(s) 919–920

    MeSH term(s) United States ; Humans ; Suicidal Ideation ; United States Food and Drug Administration ; Suicide, Attempted
    Language English
    Publishing date 2023-08-12
    Publishing country New Zealand
    Document type Letter ; Comment
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-023-01331-2
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  9. Article ; Online: Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance.

    Raschi, Emanuel / Fusaroli, Michele / Diemberger, Igor / Poluzzi, Elisabetta

    Drug safety

    2020  Volume 43, Issue 11, Page(s) 1191–1194

    MeSH term(s) Administration, Oral ; Adverse Drug Reaction Reporting Systems ; Aged ; Anticoagulants/administration & dosage ; Anticoagulants/adverse effects ; Anticoagulants/therapeutic use ; Female ; Global Health ; Humans ; Lung Diseases, Interstitial/chemically induced ; Lung Diseases, Interstitial/mortality ; Lung Diseases, Interstitial/pathology ; Male ; Pharmacovigilance ; United States ; United States Food and Drug Administration
    Chemical Substances Anticoagulants
    Keywords covid19
    Language English
    Publishing date 2020-09-15
    Publishing country New Zealand
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-020-00990-9
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  10. Article: Urgent ERCP performed with single-use duodenoscope (SUD) in patients with moderate-to-severe cholangitis: Single-center prospective study.

    Masciangelo, Graziella / Cecinato, Paolo / Bacchilega, Igor / Masetti, Michele / Ferrari, Rodolfo / Zagari, Rocco Maurizio / Napoleon, Bertrand / Sassatelli, Romano / Fusaroli, Pietro / Lisotti, Andrea

    Endoscopy international open

    2024  Volume 12, Issue 1, Page(s) E116–E122

    Abstract: Background and study ... ...

    Abstract Background and study aims
    Language English
    Publishing date 2024-01-19
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 2761052-4
    ISSN 2196-9736 ; 2364-3722
    ISSN (online) 2196-9736
    ISSN 2364-3722
    DOI 10.1055/a-2219-0826
    Database MEDical Literature Analysis and Retrieval System OnLINE

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