Statin alternatives for the treatment of hypercholesterolemia - a safety evaluation
Statins are well established as the first-line treatment to reduce low-density-lipoprotein cholesterol (LDL-C) and cardiovascular (CV) events, but some patients are unable to tolerate effective doses or sometimes any dose of statins and alternative treatments may be required.
Mining and influencing factors analysis of sacituzumab govitecan adverse drug event based on FAERS database
Utilizing the FAERS database, this study aims to analyze the ADE signals of sacituzumab govitecan to provide references for clinical safety.
Cardiovascular outcomes of urate-lowering therapies in patients with gout or hyperuricemia: a network meta-analysis
To evaluate the comparative cardiovascular safety of urate-lowering therapies (ULTs) in patients with gout or hyperuricemia.
Adverse events associated with aromatase inhibitors: an analysis of real-world datasets and drug-gene interaction network
Aromatase inhibitors (AIs) are commonly used to treat postmenopausal hormone receptor positive breast cancer, but there is currently a lack of comprehensive safety reports on AIs in large-scale cohorts.
Pharmacovigilance insights into drug-induced cystitis: analysis of FDA data from 2004 to 2024
Drug-induced cystitis (DIC) significantly impacts patient quality of life and treatment outcomes. This study investigates the incidence and characteristics of DIC using data from the FDA Adverse Event Reporting System (FAERS).
Safety assessment of cabozantinib in patients with renal cell carcinoma: retrospective pharmacovigilance study based on FAERS database
This study was designed to conduct data mining through the Food and Drug Administration Adverse Event Reporting System (FAERS) to assess adverse events (AEs) associated with cabozantinib in the treatment of renal cell carcinoma.
Preserving residual kidney function in persons on peritoneal dialysis: the role of pharmacotherapy
Increased reporting of accidental overdose with glucagon-like peptide-1 receptor agonists: a population-based study
The use of online and/or compounding pharmacies to access glucagon-like peptide-1 receptor agonists (GLP-1 RAs) increases the risk for prescription error (e.g. accidental overdose) especially in racial, ethnic, and socioeconomic disadvantaged groups.
Examining the safety of belimumab, especially in children: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database
Belimumab was approved in the US in 2019 for children with Systemic lupus erythematosus (SLE), making it the only medicine that can treat SLE in both adults and children. The authors retrospectively investigated adverse events (AEs) by data-mining a self-reported database.
Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database
This investigation aims to identify and evaluate the most common and critical drugs associated with the risk of noninfectious myocarditis utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Is metformin safe in pregnancy: a focus on offspring outcomes
Metformin has been part of treatment algorithms for type 2 diabetes mellitus (T2DM) for decades. While it has formal approval in the U.S.A. for treatment of T2DM, it is used off-label in gestational diabetes mellitus (GDM), polycystic ovarian syndrome (PCOS), and ovarian hyperstimulation prevention. Its role as an insulin sensitizer has made it an attractive therapeutic to address the insulin resistance seen in these syndromes. In 2022, the European Union approved metformin as the only oral antidiabetic medication for diabetes in pregnancy. While its safety and benefits for the mother are well documented, it does cross the placenta with plasma concentrations comparable between mother and child at delivery.
Safety concerns of aztreonam: a real-world disproportionality analysis based on FDA adverse event reporting system
Aztreonam was approved by the FDA for treating Gram-negative infections, including metallo-β-lactamase producers. This study extensively evaluated aztreonam-related adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) database for a better understanding of toxicities.
Ocular adverse events associated with GLP-1 receptor agonists: a real-world study based on the FAERS database and network pharmacology
This study evaluates the risk of ocular adverse events (AEs) associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) using data from the FDA Adverse Event Reporting System (FAERS) and network pharmacology methods.
Real-world analysis of levetiracetam-associated rhabdomyolysis: insights from the FDA adverse event reporting system
Levetiracetam, a widely prescribed antiseizure medication, is recognized for its broad-spectrum efficacy, good tolerability, and minimal drug interactions. This study examines the association between levetiracetam and rhabdomyolysis, utilizing real-world data from the FDA Adverse Event Reporting System (FAERS) database to further elucidate its safety profile.
A real-world pharmacovigilance study of tafasitamab: data mining of the US food and drug administration adverse event reporting system
Tafasitamab is the first anti-CD19 monoclonal antibody approved for relapsed/refractory diffuse large B-cell lymphoma patients ineligible for autologous stem cell transplantation. The study was designed to evaluate tafasitamab-associated adverse events (AEs) by data mining the United States Food and Drug Administration Adverse Event Reporting System (FAERS).
Mining and analysis of adverse event signals of vandetanib based on the FAERS database
By analyzing the signal mining of vandetanib AEs, it provides a reference for the rational clinical use of the drug.
Mining and analysis of adverse event signals for alendronate based on the real-world data of FDA adverse event reporting system database
Our study aims to assess alendronate-related adverse events (AEs) from the US FDA adverse event reporting system database.
A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) for gemcitabine
Gemcitabine is widely used in the treatment of various cancers. This study aims to evaluate gemcitabine-associated adverse events (AEs) using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Adverse events associated with carbamazepine: a pharmacovigilance study using the FDA Adverse Event Reporting System
Carbamazepine (CBZ) is a commonly used antiseizures medications (ASM), but its adverse drug reactions (ADRs) can impact the successful management of epilepsy. There are currently limited systematic studies on ADRs related to CBZ, necessitating further investigation.
Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system
Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.
