Results 21 to 30 of about 588,781 (167)

Depression Events Associated with Proton-Pump Inhibitors in Postmarketing Drug Surveillance Data

Pharmacoepidemiology, 2023
Proton-pump inhibitors, PPIs, are widely prescribed and are available over the counter for prolonged reduction of stomach acid production and related disorders. PPIs irreversibly inhibit the hydrogen/potassium ATPase in gastric parietal cells.
Tigran Makunts, Haroutyun Joulfayan, Kenneth Ta, Ruben Abagyan   +3 more
doaj   +1 more source

SURVEILLANCE OF RARE EVENTS. ON EVALUATION OF THE SETS METHOD [PDF]

, 1995
Continual surveillance aiming to detect an increased frequency of some rare event is of interest in several different situations in quality control, medicine, economics and other fields.
Arnkelsdóttir, Hrafnhildur
core   +1 more source

Postmarketing surveillance on the clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF‐Japan): One‐year safety and effectiveness analyses

Journal of Arrhythmia, 2020
Background The safety and effectiveness of edoxaban in real‐world clinical settings have not yet been elucidated thoroughly among Japanese patients with nonvalvular atrial fibrillation (NVAF).
Takeshi Yamashita, Yukihiro Koretsune, Tomoko Nagao, Kazuhito Shiosakai   +3 more
doaj   +1 more source

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study [PDF]

Intestinal Research, 2021
Background/Aims Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’
Tadakazu Hisamatsu, Yasuo Suzuki, Mariko Kobayashi, Takashi Hagiwara, Takeshi Kawaberi, Haruhiko Ogata, Toshiyuki Matsui, Mamoru Watanabe, Toshifumi Hibi   +8 more
doaj   +1 more source

Postmarketing Surveillance Methodologies

, 1988
This article describes and discusses the strengths and limitations of the major pharmacoepidemiologic methodologies employed in postmarketing drug surveillance and describes the current status of the U.S. surveillance system.
Stanley A. Edlavitch
core   +1 more source

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study

Journal of Arrhythmia, 2019
Background Apixaban, a non‐vitamin K oral anticoagulant (NOAC), was approved in Japan in 2012 for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation (NVAF).
Hiroshi Inoue, Michiaki Umeyama, Takako Yamada, Hiroyuki Hashimoto, Akira Komoto, Masahiro Yasaka   +5 more
doaj   +1 more source

Post-marketing safety surveillance and re-evaluation of Xueshuantong injection

BMC Complementary and Alternative Medicine, 2018
Background Traditional Chinese medicine injections (TCMIs) have been widely used to treat severe and acute diseases due to their high bioavailability, accurate curative effect, and rapid effect.
Chunxiao Li, Tao Xu, Peng Zhou, Junhua Zhang, Ge Guan, Hui Zhang, Xiao Ling, Weixia Li, Fei Meng, Guanping Liu, Linyan Lv, Jun Yuan, Xuelin Li, Mingjun Zhu   +13 more
doaj   +1 more source

Incidence, Risk Factors and Management of Adverse Events in Contemporary Real‐World Care of Children with Juvenile Idiopathic Arthritis

Arthritis Care &Research, Accepted Article.
Objective We describe the frequency, risk factors, severity, and management of actionable and serious adverse events (AAE and SAE) in children with newly diagnosed Juvenile Idiopathic Arthritis (JIA) in Canada. Methods We enrolled patients within 3 months of JIA diagnosis in the Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) Registry,
Bashayer Alnuaimi, Roberta A. Berard, Jean‐Philippe Proulx‐Gauthier, Heinrike Schmeling, Michelle Batthish, Gilles Boire, Adam M. Huber, Dax G. Rumsey, Jaime Guzman, Gaëlle Chédeville, The CAPRI registry Investigators   +10 more
wiley   +1 more source

A Blockchain-Based Post-Marketing Surveillance System for Medical Devices [PDF]

مجله علوم پزشکی صدرا
Nowadays, medical devices are widely used around the world. In every country, the safety of these devices is inextricably related to public health and security.
Ali Tavakoli Golpaygani, Fereshteh-Azadi Parand, Mohammad Amin Keshavarz   +2 more
doaj   +1 more source

Current Standards of Monitoring Models in Healthcare Settings

Advanced Intelligent Discovery, EarlyView.
AI/ML‐enabled medical devices are entering clinical practice faster than monitoring standards mature. This review highlights gaps in postmarket surveillance, limited use of predetermined change‐control plans, and the need for ongoing performance tracking, drift detection, explainability, and workflow‐aware governance to support safer, more reliable ...
Alan Kay, Daljit Takher, Wenting Liu, Emily Wittrup, Gilbert S. Omenn, Kayvan Najarian   +5 more
wiley   +1 more source