Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance [PDF]
Diabetes & Metabolism Journal, 2023 Background To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.
Jun Sung Moon +12 more
doaj +1 more source
A Real-World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database. [PDF]
Cancer MedABSTRACT Background Fruquintinib is a highly selective small‐molecule inhibitor that targets vascular endothelial growth factor receptors and is approved for the treatment of metastatic colorectal cancer. Given its increasing clinical adoption, a comprehensive pharmacovigilance evaluation of the adverse events (AEs) is warranted.
Xu Y, Wang D, Xu Y.
europepmc +2 more sources
Real-World Use of Generic Meropenem: Results of an Observational Study
Antibiotics, 2021 Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
Santiago Garnica-Velandia +2 more
doaj +1 more source
Stepwise approach of development of dermo‐cosmetic products in healthy and atopic dermatitis paediatric population: safety evaluation, clinical development and postmarket surveillance [PDF]
Journal of the European Academy of Dermatology and Venereology, 2019 AbstractBackground/objectivesPaediatric skin, considered sensitive, and infant skin, more susceptible to percutaneous toxicity, require specially formulated cosmetic products. As recently shown, early use of emollients in infants “at risk” of developing atopic dermatitis has shown controversial results in reducing the incidence of atopic dermatitis ...
V. Ribet +5 more
openaire +2 more sources
Journal of Arrhythmia, 2021 Background Direct oral anticoagulants (DOACs) are the recommended first‐line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF).
Takeshi Yamashita +3 more
doaj +1 more source
Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
, 2014 A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]
, 2010 Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y. +3 more
core +1 more source
Neonatal Safety Information Reported to the FDA During Drug Development Studies. [PDF]
, 2018 BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates
Ariagno, Ron +8 more
core +3 more sources
Therapeutic Advances in Drug Safety, 2019 Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj +5 more
doaj +1 more source