Results 41 to 50 of about 6,029 (168)

Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study [PDF]

Diabetes & Metabolism Journal
Background To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM). Methods This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015
Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park   +5 more
doaj   +1 more source

The Rising Misuse of Pharmacovigilance Reporting Systems: A Threat to Evidence‐Based Medicine

Clinical Pharmacology &Therapeutics, Volume 119, Issue 2, Page 318-321, February 2026.
In recent years, different national and international regulatory authorities, notably the FDA, have made their adverse event repositories publicly available, offering user‐friendly dashboards. This has led to a large increase in low‐quality, poorly reported research using adverse event reporting databases (e.g., FDA’s Adverse Event Reporting System ...
Charles Khouri, Alex Hlavaty, Michele Fusaroli, Nitin Joshi, Francesco Salvo, Andrew Bate, Antoine Pariente, Emanuel Raschi   +7 more
wiley   +1 more source

Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope for the treatment of adult patients with growth hormone deficiency

Therapeutic Advances in Endocrinology and Metabolism, 2012
Objective : To describe the rationale and design of PATRO Adults, a postmarketing surveillance study of the long-term efficacy and safety of somatropin (Omnitrope ® ) for the treatment of adult patients with growth hormone deficiency (GHD).
Paolo Beck-Peccoz, Francesco Minuto, Alfonso Leal-Cerro, Markus Zabransky, Günter Stalla   +4 more
doaj   +1 more source

Improving Drug Safety: The Importance of Postmarking Drug Surveillance [PDF]

, 2004
Improved postmarketing surveillance system may reduce the number of adverse reactions to prescription drugs that under the current system continue to rise as the number of prescriptions written in the U.S ...
James Nyberg, Robert N. Butler
core  

Current Trends in Duchenne Muscular Dystrophy Research and Therapy: 3D Cardiac Modelling

Journal of Cachexia, Sarcopenia and Muscle, Volume 17, Issue 1, February 2026.
ABSTRACT Duchenne muscular dystrophy (DMD), caused by dystrophin deficiency, presents a multifaceted challenge that affects both skeletal muscle function and cardiomyocyte homeostasis, causing progressive degeneration and life‐threatening cardiac complications by adolescence.
Marta Przymuszała, Marta Białobrzeska, Józef Dulak, Urszula Florczyk‐Soluch   +3 more
wiley   +1 more source

Multidimensional Assessment of Neurological Adverse Reactions Related to PD‐1 Inhibitors: A Real‐World Pharmacovigilance Study

CNS Neuroscience &Therapeutics, Volume 32, Issue 1, January 2026.
This pharmacovigilance study systematically analyzed PD‐1 inhibitor–associated neurological adverse events using FAERS data from 2014 to 2024. Central nervous system toxicities, including encephalitis and brainstem encephalitis, were most prominent. Older age, female sex, specific cancer types, and combination therapies increased the risk, with most ...
Xiaofeng Hu, Xiaoli Wang, Bufu Tang, Dehuan Zhang, Rongbing Cai, Hui Jiang, Yaling Lin, Yiheng Song, Yiou Wang, Hairuo Huang, Dandan Guo, Xubin Sun, Hongjie Fan   +12 more
wiley   +1 more source

Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System

International Journal of Dermatology, Volume 65, Issue 1, Page 108-118, January 2026.
ABSTRACT Background The United States Food and Drug Administration (FDA) approved oral finasteride for androgenetic alopecia. In 2022, approximately 2.6 million U.S. men used it for hair loss and prostate conditions. Post‐finasteride syndrome (PFS), proposed in 2012, involves persistent sexual and neuropsychiatric adverse events (AEs) after cessation ...
Aditya K. Gupta, Mesbah Talukder, Sharon A. Keene, Mary A. Bamimore   +3 more
wiley   +1 more source

MDDC: An R and Python package for adverse event identification in pharmacovigilance data

Scientific Reports
The safety of medical products continues to be a significant health concern worldwide. Spontaneous reporting systems (SRS) and pharmacovigilance databases are essential tools for postmarketing surveillance of medical products.
Anran Liu, Raktim Mukhopadhyay, Marianthi Markatou   +2 more
doaj   +1 more source

The US Food and Drug Administration’s expedited approval programs: addressing premarket flexibility with enhanced postmarket evidence generation [PDF]

, 2018
When the editors of Clinical Trials solicited our review on the U.S. Food and Drug Administration’s (FDA) expedited development and review programs, we anticipated there would be accompanying commentaries from other academics with differing opinions, or ...
Naci, Huseyin, Ross, Joseph S., Wallach, Joshua D.   +2 more
core   +1 more source

Understanding Cardiovascular Events With JAK Inhibitors: Similarities and Differences of the Vascular Effects Between Different JAK Inhibitors on Endothelial Cells Exposed to Inflammatory Cytokines

ACR Open Rheumatology, Volume 7, Issue 12, December 2025.
Objective A cardiovascular safety issue has been associated with JAK inhibitors (JAKi). This study compares the effects of distinct approved JAKi on endothelial cell (EC) dysfunction and apoptosis during inflammation. Methods Massive inflammation was induced in human vascular ECs by tumor necrosis factor (TNF) with interleukin‐17A (IL‐17A) treated or ...
Aliki Zavoriti, Pierre Miossec
wiley   +1 more source