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A Risk-Based Approach for Safety Case Follow-up of Adverse Event Reports in Pharmacovigilance
This study presents an analysis of follow-up attempts for adverse event (AE) reports, shedding light on the characteristics of a risk-based approach...
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Analysis of Adverse Events of Cholinesterase Inhibitors and NMDA Receptor Antagonists on Arrhythmias Using the Japanese Adverse Drug Event Report Database
BackgroundThe association between anti-dementia drugs and arrhythmia is uncertain. In addition, the effects of certain drug combinations are not yet...
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A comparison between the adverse event profiles of patients receiving palbociclib and abemaciclib: analysis of two real-world databases
BackgroundPalbociclib and abemaciclib are cyclin-dependent kinase (CDK) 4/6 inhibitors currently used to treat breast cancer. Although their...
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Analysis of drug-induced interstitial lung disease caused by herbal medicine using the Japanese Adverse Drug Event Report database
BackgroundDrug-induced interstitial lung disease (DIILD) is a severe adverse event leading to morbidity and mortality. This study evaluated the...
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Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review
BackgroundPreventable harm in healthcare is a growing public health challenge. In addition to the economic costs of safety failures, adverse drug...
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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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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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Drug-Induced QT Prolongation and Torsade de Pointes in Spontaneous Adverse Event Reporting: A Retrospective Analysis Using the Japanese Adverse Drug Event Report Database (2004–2021)
BackgroundDrugs with new mechanisms of action are continually being developed, but it is difficult to capture whether a drug induces QT...
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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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Analysis of the association between Janus kinase inhibitors and malignant skin tumors using the Food and Drug Administration Adverse Event Reporting System
BackgroundMalignant skin tumors are adverse events of concern regarding Janus kinase (JAK) inhibitors.
AimThis study aimed to evaluate the...
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Venetoclax adverse event monitoring: a safety meta-analysis of randomized controlled trials and a retrospective evaluation of the FAERS
Concerns persist about venetoclax’s long-term safety in larger populations, with limited evidence of infrequent and delayed adverse events (AEs). The...
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Rhabdomyolysis or Severe Acute Hepatitis Associated with the Use of Red Yeast Rice Extracts: an Update from the Adverse Event Reporting Systems
Purpose of ReviewElevated plasma levels of low-density lipoprotein cholesterol (LDL-C) are a major risk factor for atherosclerotic cardiovascular...
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Association Between Antidiabetic Drugs and Delirium: A Study Based on the Adverse Drug Event Reporting Database in Japan
Background and ObjectiveSeveral associations between diabetes mellitus and delirium have been reported; however, they have been inconsistent, and...
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Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose
IntroductionCOVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A...
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Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS)
IntroductionBivalent mRNA coronavirus disease 2019 (COVID-19) vaccines may be simultaneously administered with other recommended vaccines, including...
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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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The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial
BackgroundIncorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and...
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Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics
IntroductionPostmarketing drug safety surveillance research has focused on the product-patient interaction as the primary source of variability in...
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Does financial hardship associate with abnormal quantitative myocardial perfusion and major adverse cardiovascular event?
BackgroundData on impact of financial hardship on coronary artery disease (CAD) remain incomplete.
MethodsConsecutive subjects referred for clinical...
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Newer Antiseizure Medications and Suicidality: Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) Database
BackgroundThe association between antiseizure medications (ASMs) and suicidality remains controversial. Analyses of additional datasets are needed to...
