Pharmacovigilance - Science topic

This study explores the feasibility of leveraging consumer reviews for passive surveillance of foodborne illnesses, drawing parallels with pharmacovigilance systems. Utilizing a mixed-methods approach, including a literature review, qualitative interviews with key stakeholders, and quantitative analysis of 56,000 restaurant reviews using a bidirect...

A infecção hospitalar, também conhecida como infecção nosocomial, representa uma preocupação significativa para pacientes e profissionais de saúde. Este problema é agravado pela resistência bacteriana, resultante do uso inadequado de antimicrobianos. A negligência nos hospitais e a prescrição excessiva desses medicamentos contribuem para esse cenár...

A infecção hospitalar, também conhecida como infecção nosocomial, representa uma preocupação significativa para pacientes e profissionais de saúde. Este problema é agravado pela resistência bacteriana, resultante do uso inadequado de antimicrobianos. A negligência nos hospitais e a prescrição excessiva desses medicamentos contribuem para esse cenár...

The research article provides an in-depth analysis of the European Medicines Agency (EMA) and the Directorate General of Drug Administration (DGDA), focusing on their historical development, organizational structures, and functional roles in ensuring the quality and safety of pharmaceuticals. The study highlights the origins of drug regulation, tr...

The combination of immune checkpoint inhibitors (ICIs) and angiogenesis inhibitors (AGIs) is widely used in cancer treatment; however, drug–drug reactions (DDIs) remain unknown. We aimed to identify interaction signals for the concomitant use of ICIs and AGIs. Data were obtained from the US FDA Adverse Event Reporting System (FAERS) from January 1,...

Background Antibody–drug conjugates (ADCs) combine the targeted nature of monoclonal antibodies with the potent efficacy of small-molecule cytotoxic drugs. However, they also carry unique safety risks, including lung toxicity. Objective To conduct a systematic review and analysis of ADC-related interstitial lung disease (ILD) incidence, characteri...

Aims The use of (GLP‐1 RAs) among pregnant women is escalating, yet safety data remain insufficient. This study aims to comprehensively assess adverse drug reactions (ADRs) associated with GLP‐1 RAs in pregnant women using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods FAERS data from 2004 to 2023 were...

Background/Objectives: While breastfeeding is highly recommended, breastfed infants may be exposed to drugs by milk due to maternal pharmacotherapy, resulting in a risk of adverse drug events (ADE) or reactions (ADRs). The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is an online pharmacovigilance database, while t...

Ichthammol ointment is a sulfur-containing ointment which is used for the treatment of lower limb leg ulcerations and skin conditions such as atopic eczema and dermatitis. It has been in use for centuries as a topical ointment. The most common adverse drug reaction (ADR) associated with ichthammol use is skin irritation. This case was collected fro...

Cefoperazone and sulbactam are commonly used third-generation cephalosporins used widely for the treatment of various bacterial infections. They are one of the most commonly used antibiotics in both hospitalized patients and outpatients. They have been associated with an increasing prevalence of hypersensitivity reactions, mediated by a varied arra...

Background/Objectives: Clinical studies show that SARS-CoV-2 vaccination sometimes entails a severe and disabling chronic syndrome termed post-acute-COVID-19-vaccination syndrome (PACVS). PACVS shares similarities with long COVID. Today, PACVS is still not officially recognised as a disease. In contrast, long COVID was registered by health authorit...

Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, is a crucial element of public health. In India, pharmacovigilance systems are in the developmental stage and face numerous challenges in ensuring drug safety. The rapid expansion o...

We develop a Bayesian Power generalized Weibull shape parameter (PgWSP) test as statistical method for signal detection of possible drug-adverse event associations using electronic health records for pharmacovigilance. The Bayesian approach allows the incorporation of prior knowledge about the likely time of occurrence along time-to-event data. The...

Pharmacovigilance is an essential aspect of ensuring drug safety and promoting public health, focusing on detecting, evaluating, understanding, and preventing adverse drug reactions (ADRs). India, with its vast and diverse population, faces numerous challenges in establishing an effective pharmacovigilance system that ensures the safety of medicine...

Introduction The antimalarial medicines used in Seasonal Malaria Chemoprevention (SMC) campaigns are generally well-tolerated but adverse drug reactions (ADRs) can occur. Monitoring, reporting, and prompt management of ADRs is essential to build and maintain trust in SMC campaigns in the implementing communities. The caregiver's decision to report...

Cytochrome P450 3A4 (CYP3A4) is a crucial enzyme involved in the Phase I metabolism of numerous medications used in clinical practice. Its potential significance in pediatric pharmacotherapy is underscored by the unique metabolic profile of children, which differs markedly from adults, especially in neonates, infants, and young children due to deve...

Introduction Diabetes mellitus (DM) is increasingly recognized as a possible consequence of statin therapy. Secondary analysis of randomized clinical trials and limited observational cohort analyses have suggested that women may be more likely than men to experience statin-associated DM. No analyses of real-world drug safety data addressing this qu...

Adverse drug events (ADEs) in clinical trials present significant challenges, as delayed or inaccurate detection can compromise patient safety and trial outcomes. This research focuses on automating the detection of ADEs using machine learning models, leveraging the FDA Adverse Event Reporting System (FAERS) dataset. The goal is to improve the spee...

Improving adverse events following immunisation (AEFI) detection is vital for vaccine safety surveillance, as an early safety signal can help minimize risks. In February 2022, the World Health Organization reported a preliminary signal on sudden sensorineural hearing loss (SSNHL) following coronavirus disease 2019 (COVID-19) vaccination, 54 million...

Objective Cilostazol is indicated for alleviating intermittent claudication (IC) in stable-phase peripheral arterial disease (PAD) patients. Conducting data mining on adverse events (AEs) of cilostazol in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to explore its potential medication risks and advance...

Desde el inicio de la pandemia de COVID-19 en 2020, la farmacovigilancia ha cobrado una relevancia fundamental en la evaluación de la seguridad de las vacunas. La Organización Mundial de la Salud (OMS) y la Organización Panamericana de la Salud (OPS) han instado a establecer sistemas de vigilancia robustos y confiables, que permitan una detección t...

The FDA Adverse Event Reporting System (FAERS) is a large-scale repository of reports concerning adverse drug events (ADEs). The same published clinical study or report may be reviewed by multiple companies or healthcare professionals and reported separately to the FDA, leading to a significant presence of duplicate reports in FAERS. These duplicat...

Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse drug effects. The field aims to systematically monitor medicines and promote their safe, effective use. However, pharmacovigilance faces challenges such as fragmented systems and passive reporting. As the discipline advances, priorities now include centralizing d...

Background As routinely collected patient data have become increasingly accessible over the years, more attention has been directed at the ethics of using such data for research. Patient data is often available to researchers through patient registries that typically collect data of patients with a specific condition. While ethical guidelines for u...

Purpose Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been reported to exhibit antiarrhythmic effects. However, there is conflicting evidence regarding the association between SGLT2 inhibitors and ventricular arrhythmias or sudden cardiac death (SCD). We utilized the US FDA Adverse Event Reporting System (FAERS) database to investigate the...

Introduction: The safety of biologics, other than TNF-α in-hibitors, during pregnancy has not been sufficiently established. To assess the risk of pregnancy-related adverse outcomes of biologics used for psoriasis, compared to TNF-α inhibitors, we utilized the WHO global pharmacovigilance database (1968-2024). Methods: We utilized the World Health...

Indocyanine green (ICG) is a diagnostic dye commonly used in medical imaging and liver function monitoring. Given its widespread use, there is a need for detailed evaluations of its adverse drug reactions in real-world settings. As the comprehensive overview of its safety profile is very limited, this study aimed to analyze the adverse events (AEs)...

Objectives Limited information is available on the safety of a rechallenge with an immune checkpoint inhibitor (ICI) after occurrence of an immune-related adverse event (irAE). We aim to identify potential emergent safety signals. Design This is an update of our observational pharmacovigilance cohort study. Setting We exanimated individual case s...

Background Selpercatinib, a highly selective tyrosine kinase inhibitor, has emerged as an excellent treatment option for patients with rearranged during transfection-altered cancer. However, there is limited comprehensive safety information available for selpercatinib through large-scale post-marketing monitoring. Methods This study conducted a co...

Pharmacovigilance findings have marked clozapine use. Prescribers and package inserts worldwide focus on clozapine-induced neutropenia. The literature on clozapine adverse drug reactions (ADRs) for those under age 18 and their associated fatal outcomes is limited. Reports to the World Health Organization’s global pharmacovigilance database (VigiBas...

Previous studies have suggested an association between vaccines and autoimmune diseases, but they were limited by their narrow focus and timeframe. Therefore, this study conducted the first large-scale international analysis to investigate the impact of various vaccines on autoimmune liver diseases. Utilizing WHO’s VigiBase data from 1968 to 2024,...

Pharmacovigilance is meant to ensure patients’ safety from adverse drug reaction (ADR). This study aims to assess knowledge, attitude and practice of pharmacovigilance and ADR reporting among pharmacists in Benghazi- Libya. A cross-sectional questionnaire-based study involving knowledge, attitude and practice of pharmacovigilance and it targeted 93...

Background: ADRs pose significant risks to patient safety, making effective reporting essential for pharmacovigilance. This study aimed to assess the KAP of nurses regarding ADR reporting in Herat, Afghanistan. Methods: A cross-sectional study was conducted from January to March 2024, involving 385 nurses across various healthcare facilities, inclu...

Clarifying and differentiating the causes of diseases is an essential step in any clinical activity, but it takes on particular relevance and complexity in the case that arise following vaccinations. The WHO has proposed a protocol that uses a list of specific questions about vaccine-related adverse events and an algorithm for making a judgement. H...

Introdução A incorporação de uma nova tecnologia no sistema de saúde requer um grande planejamento, envolve ações para a sua implementação, monitoramento dos resultados de efetividade e da segurança na população em uso. A miltefosina é o primeiro e único tratamento disponível na forma oral para leishmaniose e foi distribuída no Sistema Único de Saú...

It’s well known that sex is a risk factor for the occurrence of adverse events (AEs), most of which have found sex differences. Real-world data studies on the sex differences of fall-risk-increasing drugs (FRIDs) are few and far between, with most small-scale retrospective studies based on FRID classes. To establish a list of FRIDs and describe the...

Several international pharmacovigilance agencies have issued warnings regarding the potential risk of myasthenia gravis (MG) following statin therapy. Our study investigated this association using population-based electronic health records in Hong Kong. We conducted a sequence of target trial emulation (TTE) for interpersonal comparison and a self-...

Introduction Enfortumab vedotin (EV) combined with pembrolizumab (EV+P) is a promising first-line therapy for metastatic urothelial carcinoma. While it has shown significant efficacy, severe cutaneous adverse events such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. We present this case as another exampl...

Purpose The etiology and pathophysiology of vaccine-associated chronic urticaria (CU) remain unclear, particularly during the coronavirus disease 2019 (COVID-19) pandemic. Thus, this study aimed to comprehensively investigate the global burden and long-term trends of vaccine-associated CU, with a focus on the associated vaccines and the distributio...

Disproportionality analyses are the most-commonly used study design used in the post-marketing phase to detect suspected adverse drug reactions in individual case safety reports. Recent years have witnessed an exponential increase in published articles on disproportionality analyses, thanks to publicly accessible databases. Unfortunately, this tren...

The Janus kinase (JAK) inhibitors are treatment options for autoimmune diseases. Numerous safety concerns have been raised. The European Medicines Agency updated the product information of tofacitinib to include the risk of fractures—but not for other JAK inhibitors. We conducted a global pharmacovigilance analysis of previously investigated JAK in...

Aim. To analyze the changes in the professional functions of pharmacists because of the growing social burden on pharmacies, as well as the prospects for this profession. Materials and methods. The objects of the study were regulatory legal acts on the regulation of pharmaceutical activities; modern approaches to the organization of pharmaceutical...

Patient safety is of utmost importance. Amgen’s Global Patient Safety (GPS) department serves patients by monitoring to ensure a favorable benefit-risk profile of Amgen products (medicines, devices, and combination products) through the practice of Pharmacovigilance. Pharmacovigilance is defined by the World Health Organization as "the science and...

Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used during pregnancy. Due to their fetotoxicity, NSAIDs are contraindicated during the third trimester. There is ongoing controversy about the extent to which NSAIDs may cause cardiovascular and renal impairment in the fetus earlier in the second trimester. P...

The β-Lactam antibiotics represent a widely used class of antibiotics, yet the latent and often overlooked risk of coagulation dysfunction associated with their use underscores the need for proactive assessment. Machine learning methodologies can offer valuable insights into evaluating the risk of coagulation dysfunction associated with β-lactam an...

Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the USA, brodalumab has a boxed warning regarding suicidal ideation a...

Introduction: Drugs in the family of nonsteroidal anti-inflammatory analgesics (NSAIDs) can cause adverse drug reactions (ADRs) and drug-drug interactions, hence the importance for the stomatologist to know how to prescribe and use each drug rationally. Currently, there is no information on the pharmacovigilance actions of analgesics that are the...

Background Triptans selectively agoniste 5-Hydroxytryptamine(5-HT) receptors and are widely used in the treatment of migraine. Nevertheless, there is a dearth of comprehensive real-world clinical research on the safety of triptans. In light of the growing prevalence of migraine, it is imperative to gain a deeper understanding of the true extent of...

Background Plecanatide is a selective gastrointestinal peptide used for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Given its widespread use, understanding the long-term safety of plecanatide in real-world settings is essential. Methods Data for this study were sourced from the Uni...

In recent years, the expanding volume of biological literature, clinical notes, and electronic health records (EHRs) has presented both a barrier and an opportunity for healthcare improvement. Biological text mining, which employs natural language processing (NLP) methods, is a viable alternative for extracting useful insights from unstructured bio...

Introduction Anxiety diagnoses have surged recently during and after the COVID-19 pandemic. Lorazepam is widely recognized for its efficacy in treatment of anxiety, as well as insomnia, etc. However, the long-term safety profile of lorazepam in extensive patient populations has not been thoroughly established. Methods This study aims to evaluate t...

Objective To investigate the association between glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and ophthalmic adverse drug reactions (OADRs) using data from the FDA Adverse Event Reporting System (FAERS). Methods This retrospective pharmacovigilance study analyzed post-marketing FAERS data from 2018 to 2023 to identify GLP-1 RA-related OAD...

Background: Type 2 Diabetes mellitus (T2DM) requires long-term OHAs, which is often associated with adverse drug reactions (ADRs) as well as poor compliance. Pharmacovigilance could be an effective tool for detection, assessment, understanding and prevention of these ADRs alongside medication adherence evaluation becomes vital in order to provide a...

Background With the advent of drugs designed to selectively target the KRAS-G12C mutant protein, sotorasib and adagrasib have exhibited remarkable efficacy in patients with KRAS G12C mutant lung cancers. Nevertheless, the safety profiles of these agents in a real-world context remain undisclosed. Methods Data was systematically extracted from the...

Many countries ban direct-to-consumer advertising (DTCA) of prescription drugs due to potential health and financial risks. However, the internet and social media now offer new ways for pharmaceutical companies to share information and promote products. Covert marketing—indirectly promoting products through news media—has emerged as an alternative....

Risk minimisation measures (RMMs) aim to ensure safe use of medicines, but their implementation in clinical practice is complicated by the diversity of stakeholders whose clinical decision making they seek to inform. Clinical practice guidelines (CPGs) are considered integral in clinical decision making. To determine the extent to which RMMs are in...

Background We systematically reviewed Mendelian randomization (MR) studies and summarized evidence on the potential effects of different antihypertensive drugs on health. Methods We searched PubMed and Embase for MR studies evaluating the effects of antihypertensive drug classes on health outcomes until 22 May 2024. We extracted data on study char...

Background A national Oral Cholera Vaccine (OCV) Euvichol-Plus® campaign was launched in Lebanon, in response to the first outbreak in three decades, recorded in October 2022. The OCV vaccination campaign was carried out between November 2022 and February 2023. This study aims to cover adverse events reports, received at the Lebanese National Pharm...

Introduction Veterinary antibiotics are essential for maintaining animal health and welfare, however, small-scale farmers in Malawi face challenges in accessing them due to limited availability, affordability, and long distances to rural drug retailers. Methods This study mapped the veterinary antibiotic distribution chain, examined the governance...

Reading has long been recognized as a fundamental method of acquiring and transferring knowledge and information. However, the emergence of Artificial Intelligence (AI) has prompted a reevaluation of traditional knowledge transfer methods and their potential for enhancement. An empirical study with 128 participants measured the time taken to proces...

Rhabdomyolysis (RML), characterized by the breakdown of skeletal muscle fibers and the release of muscle contents into the bloodstream, has emerged as a notable complication associated with Coronavirus disease 2019 (COVID-19) infection and vaccination. Studies have reported an increased incidence of RML in individuals with severe COVID-19 infection...

Objective Hypertension is a leading global risk factor for disability and death. Irbesartan, a potent angiotensin II receptor blocker, requires continuous safety monitoring. We conducted a disproportionality analysis of irbesartan-related adverse drug events (ADEs) using the FDA’s FAERS and Japan’s JADER databases. Methods We extracted irbesartan-...

The use of fixed dose combinations (FDCs) in healthcare has significant public health implications, both positive and negative. Positive aspects include simplifying treatment regimens, improving patient adherence, and cost-effectiveness, particularly in resource-constrained settings. However, negative implications arise when FDCs are used without c...

Tuberculose e hanseníase são doenças infectocontagiosas de curso crônico, consideradas como problemas de saúde pública no Brasil. Ambas são tratáveis e as drogas utilizadas são padronizadas e fazem parte do componente estratégico da assistência farmacêutica no SUS. Constituem desafios da assistência farmacêutica desses agravos, não somente a garant...

A digital point-of-care solution was implemented to test the feasibility of near-real-time bi-directional communication between pharmacovigilance experts (PVEs) and healthcare professionals (HCPs) for exchanging unique and informative adverse event (AE) information. The solution was implemented in a commercially available electronic health record (...