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Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System
Background and objectiveEvidence highlights the allergenic potential of PEGylated drugs because of the production of anti-polyethylene glycol...
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Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems
Medical science has often used adult males as the standard to establish pathological conditions, their transitions, diagnostic methods, and treatment...
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Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France
IntroductionIn 2021, the massive Covid-19 vaccination campaign in France was accompanied by an intensified pharmacovigilance monitoring of their...
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Hospitalisations Related to Adverse Drug Reactions in Switzerland in 2012–2019: Characteristics, In-Hospital Mortality, and Spontaneous Reporting Rate
IntroductionAdverse drug reactions (ADRs) contribute to morbidity, and serious ADRs may cause hospitalisation and death. This study characterises and...
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Statistical methods for exploring spontaneous adverse event reporting databases for drug-host factor interactions
BackgroundDrug toxicity does not affect patients equally; the toxicity may only exert in patients who possess certain attributes of susceptibility to...
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An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance
IntroductionDuring the signal detection process, statistical methods are used to identify drug–event combinations (DECs) which are disproportionately...
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Spontaneous reporting of adverse drug reaction among health professionals in Ghana
BackgroundSpontaneous reporting of adverse drug reactions (ADR) is an effective means of ensuring postmarketing surveillance of drugs, and health...
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Analysis of adverse drug events in pulmonary Mycobacterium avium complex disease using spontaneous reporting system
BackgroundIn Japan, Mycobacterium avium complex lung disease (MAC-LD) is the most common in nontuberculous mycobacterial lung disease. Patients...
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Introducing AEM-RADS: A novel reporting and data system for abdominal emergencies
PurposeThe Reporting and Data System (RADS) has proven successful in various medical settings, but a standardized reporting system for abdominal...
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Relationship Between Clozapine and Non-Hematological Malignant Tumors: A Pharmacovigilance Analysis Using the FDA Adverse Event Reporting System Database
Background and ObjectivesClozapine shows higher efficacy against treatment-resistant schizophrenia than other antipsychotics. This study aimed to...
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Thai stakeholders’ awareness and perceptions of the patient adverse event reporting system for herbal medicines: a qualitative study
BackgroundIn Thailand, the consumption of herbal medicines has been increasing. Adverse events (AEs) of herbal medicines have been identified through...
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Postmarketing safety profile of brexanolone: a pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS)
ObjectiveBrexanolone (Zulresso®) that was approved for the USA in March 2019 is indicated for the treatment of postpartum depression (PPD), but...
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Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database
IntroductionEvidence is lacking on withdrawal syndrome related to individual antidepressants and relevant risk factors for severe reactions.
...
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Tumor Lysis Syndrome with CD20 Monoclonal Antibodies for Chronic Lymphocytic Leukemia: Signals from the FDA Adverse Event Reporting System
Background and ObjectiveAlthough tumor lysis syndrome was reported with obinutuzumab and rituximab, the association with CD20 monoclonal antibodies...
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Liver injury associated with endothelin receptor antagonists: a pharmacovigilance study based on FDA adverse event reporting system data
BackgroundEndothelin receptor antagonists are commonly used in clinical practice, with concerns about their hepatotoxicity.
AimThis study aimed to...
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Psychiatric Adverse Reactions to Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer: Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System
BackgroundThe development of anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) has improved the survival outcomes of patients with...
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Exploring the safety profile of tremelimumab: an analysis of the FDA adverse event reporting system
BackgroundDespite the approval of tremelimumab in 2022, there is a lack of pharmacovigilance studies investigating its safety profile in real-world...
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A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS)
SummaryAbaloparatide (ABL) is a US Food and Drug Administration-approved parathyroid hormone-related peptide analog for treatment of osteoporosis in...
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Pharmacovigilance Study of Infigratinib: A Safety Analysis of the FDA Adverse Event Reporting System
BackgroundInfigratinib is a fibroblast growth factor receptor (FGFR)-specifc tyrosine kinase inhibitor indicated for the treatment of patients with...
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Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case–Control Study with a Focus on Medicines Used in Primary Care
IntroductionPrimary care provides an opportunity to prevent community acquired, medicine or drug-induced acute kidney injury. One of the barriers to...