Pharmacovigilance ≈ PharmacovigilancePharmacovigilance
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Fatal Toxic Effects Associated With Immune Checkpoint Inhibitors Open
In the largest evaluation of fatal ICI-associated toxic effects published to date to our knowledge, we observed early onset of death with varied causes and frequencies depending on therapeutic regimen. Clinicians across disciplines should …
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History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology Open
Background: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered bi…
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The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE) Open
In pharmacoepidemiology, routinely collected data from electronic health records (including primary care databases, registries, and administrative healthcare claims) are a resource for research evaluating the real world effectiveness and s…
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Immune Checkpoint Inhibitor Rechallenge After Immune-Related Adverse Events in Patients With Cancer Open
This cohort study found a 28.8% recurrence rate of the same irAE associated with the discontinuation of ICI therapy after a rechallenge with the same ICI. Resuming ICI therapy could be considered for select patients, with appropriate monit…
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Pharmacovigilance and adverse drug reaction reporting: a perspective of community pharmacists and pharmacy technicians in Sana’a, Yemen Open
Pharmacists have a significantly better knowledge than pharmacy technicians with regard to pharmacovigilance. More than half of pharmacy technicians showed a negative attitude toward ADR reporting. Therefore, educational interventions and …
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Neurologic toxicity associated with immune checkpoint inhibitors: a pharmacovigilance study Open
ICIs produce a spectrum of distinct classes of neurologic AEs that can cause significant morbidity and mortality and tend to occur early and with class-specific associations.
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KNOWLEDGE, ATTITUDE AND PRACTICE OF YEMENI PHYSICIANS TOWARD PHARMACOVIGILANCE: A MIXED METHOD STUDY Open
Objective: The objective of the current study was to investigate the physician’s knowledge, attitude and practice towards pharmacovigilance.Methods: A mixed qualitative and quantitative method was conducted in this study using a face to fa…
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Bidirectional RNN for Medical Event Detection in Electronic Health Records Open
Sequence labeling for extraction of medical events and their attributes from unstructured text in Electronic Health Record (EHR) notes is a key step towards semantic understanding of EHRs. It has important applications in health informatic…
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Neurologic Serious Adverse Events Associated with Nivolumab Plus Ipilimumab or Nivolumab Alone in Advanced Melanoma, Including a Case Series of Encephalitis Open
Background Despite unprecedented efficacy across multiple tumor types, immune checkpoint inhibitor therapy is associated with a unique and wide spectrum of immune-related adverse events (irAEs), including neurologic events ranging from mil…
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The value of patient reporting to the pharmacovigilance system: a systematic review Open
Aims Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unk…
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Mendelian randomization: a novel approach for the prediction of adverse drug events and drug repurposing opportunities Open
Identification of unintended drug effects, specifically drug repurposing opportunities and adverse drug events, maximizes the benefit of a drug and protects the health of patients. However, current observational research methods are subjec…
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OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications Open
Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situati…
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Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future Open
Background: To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and pr…
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Eculizumab in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome: 10‐year pharmacovigilance analysis Open
Summary Eculizumab is the first and only medication approved for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) treatment. However, eculizumab safety based on long‐term pharmacovigilance is unkno…
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Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis Open
To facitinib and baricitinib are two of the currently available Janus kinase (JAK) inhibitors for the treatment of patients with RA. Randomized controlled trials have shown that these JAK inhibitors are as efficacious as biological DMARDs.…
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Deep learning for pharmacovigilance: recurrent neural network architectures for labeling adverse drug reactions in Twitter posts Open
Objective Social media is an important pharmacovigilance data source for adverse drug reaction (ADR) identification. Human review of social media data is infeasible due to data quantity, thus natural language processing techniques are nece…
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Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial Open
ClinicalTrials.gov NCT00712374.
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The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration Open
In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplet…
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Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study Open
Background: Adverse drug reactions (ADRs) are an important public health problem, representing a major cause of morbidity and mortality. However, several countries have no recent studies available. Since 2014, a prospective active pharmaco…
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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report Open
The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events. The aim of this prospective study was to evaluate t…
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Hematologic Complications of Immune Checkpoint Inhibitors Open
Immune checkpoint inhibitors have improved outcomes for patients with numerous hematological and solid cancers. Hematologic toxicities have been described, but the spectrum, timing, and clinical presentation of these complications are not …
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Ongoing Initiatives to Improve the Quality and Efficiency of Medicine Use within the Public Healthcare System in South Africa; A Preliminary Study Open
Introduction: South Africa has an appreciable burden of both communicable and non-communicable diseases as well as high maternal, neonatal, and child morbidity. In recent years there have been significant strides with improving the public …
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Neurologic complications of immune checkpoint inhibitors Open
Introduction: Immune checkpoint inhibitors (ICI) are associated with a wide spectrum of neurologic immune-related adverse events (irAEs) including meningo-encephalitis, myasthenia gravis and various neuropathies. Although relatively rare, …
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Cardiotoxicity associated with immune checkpoint inhibitor therapy: a meta‐analysis Open
Aims This study aimed to estimate the incidence of cardiac immune‐related adverse events (irAEs) in patients treated with immune checkpoint inhibitors (ICIs). Methods and results First, we performed an ICI pharmacovigilance analysis, findi…
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Immune Checkpoint Inhibitor-Related Cytokine Release Syndrome: Analysis of WHO Global Pharmacovigilance Database Open
Immune checkpoint inhibitors (ICIs) have proven effective in the treatment of numerous cancers; however, they have been associated with immune-related adverse events (irAEs), among which cytokine release syndrome (CRS) has been reported in…
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Disproportionality Analysis for Pharmacovigilance Signal Detection in Small Databases or Subsets: Recommendations for Limiting False-Positive Associations Open
To mitigate the risk of highlighting spurious associations with disproportionality analysis, a minimum size of 500 reports is recommended for national databases. For databases or subsets that are not country-specific, our recommendation is…
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Detection of drug–drug interactions through data mining studies using clinical sources, scientific literature and social media Open
Drug-drug interactions (DDIs) constitute an important concern in drug development and postmarketing pharmacovigilance. They are considered the cause of many adverse drug effects exposing patients to higher risks and increasing public healt…
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AI-based language models powering drug discovery and development Open
The discovery and development of new medicines is expensive, time-consuming, and often inefficient, with many failures along the way. Powered by artificial intelligence (AI), language models (LMs) have changed the landscape of natural lang…
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An historical overview over Pharmacovigilance Open
Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/b…
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The drugs that mostly frequently induce acute kidney injury: a case − noncase study of a pharmacovigilance database Open
Aims Acute kidney injury (AKI) is associated with a high hospitalization rate, accelerated long‐term decline in kidney function and a high mortality rate. Adverse drug reactions (ADRs) constitute one of the most important modifiable factor…