Results 41 to 50 of about 19,507 (228)

Real‐world trends in prenatal antirheumatic drug utilization in Ontario, Canada: A cross‐sectional time‐series analysis

Arthritis Care &Research, Accepted Article.
Objectives This study aimed to describe real‐world trends in preconception and prenatal use of antirheumatic drugs among pregnant individuals with rheumatic diseases in Ontario, Canada. Methods We conducted a time‐series analysis using repeated cross‐sectional data to examine annual patterns of disease‐modifying antirheumatic drug (DMARD) use among ...
Shenthuraan Tharmarajah, Swaleh Hussain, Sara J.T. Guilcher, Lisa M. McCarthy, Dharini Mahendira, Howard Berger, Mina Tadrous   +6 more
wiley   +1 more source

Statin use and the risk of tubulointerstitial nephritis: a real-world signal detection analysis using FDA Adverse Event Reporting System

Frontiers in Medicine
BackgroundStatins are widely prescribed for cardiovascular risk reduction but have been linked to a range of adverse effects. Tubulointerstitial nephritis (TIN), a potentially serious renal condition, has been sporadically reported with statin use.
Ayesha Yasmeen, Ayesha Yasmeen, Mamoon H. Syed, Mamoon H. Syed, Amani Khardali, Amani Khardali, Hadi A. Almansour, Hadi A. Almansour, Thamir M. Alshammari, Thamir M. Alshammari   +9 more
doaj   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Rituximab induced pulmonary edema managed with extracorporeal life support [PDF]

, 2018
Though rare, rituximab has been reported to induce severe pulmonary edema. We describe the first report of ECLS utilization for this indication. A 31-year-old female with severe thrombotic thrombocytopenic purpura developed florid pulmonary edema after ...
Aguilar, Patrick, Balsara, Keki R, Isakow, Warren, Itoh, Akinobu, Masood, Muhammad F, Miller, Jacob R, Sanfilippo, Kristen M   +6 more
core   +3 more sources

Practice, knowledge and attitude of physicians and pharmacists towards the spontaneous reporting system of adverse drug reactions in Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Introduction Introduction Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists.
Fiona A. Strobel, Thomas Stammschulte, Patrick E. Beeler   +2 more
wiley   +1 more source

Characteristics of Phase IV Clinical Trials in Oncology: An Analysis Using the ClinicalTrials.gov Registry Data

Current Oncology, 2023
The present study analyzed the characteristics of phase IV clinical trials in oncology using data from the ClinicalTrials.gov registry. The included trials were conducted between January 2013 and December 2022 and were examined for key characteristics ...
Brandon Michael Henry, Giuseppe Lippi, Ameen Nasser, Patryk Ostrowski   +3 more
doaj   +1 more source

Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?

Clinical Pharmacology &Therapeutics, EarlyView.
Pediatric drug development has achieved remarkable success in the last 20 years with over 1,000 products studied in pediatric patients. This success has been driven in part by an increased understanding of pediatric disease processes. The aspect that has been largely overlooked is the potential adverse effect of new drugs on pediatric developmental ...
Gilbert J. Burckart, Susan M. Abdel‐Rahman, Gelareh Abulwerdi, Sherbet Samuels, Rebecca Racz, Mohamed A. Mohamoud, Nicholas P. Tatonetti   +6 more
wiley   +1 more source

Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative

Clinical Pharmacology &Therapeutics, EarlyView.
The U.S. Food and Drug Administration (FDA) used an Active Postmarket Risk Identification and Analysis (ARIA) system to address a safety issue (serious infection) identified during clinical review of an application to market ustekinumab as a treatment for Crohn's disease (CD). FDA used an active‐comparator new‐user cohort design, data from six Sentinel
Joel L. Weissfeld, Geetha S. Iyer, Suna C. Seo, Andrew Giffin, Andrew L. Simon, Sheryl A. Kluberg, Emma R. Hoffman, Jamal T. Jones, Sarah K. Dutcher, Joyce A. Korvick   +9 more
wiley   +1 more source

Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer

Iranian Journal of Neurosurgery, 2019
Background and Aim: Cranfixer was approved in 2017 by the Food and Drug Administration of Iran as a skull flap fixation and also a burr hole cover.
Seyed Roholah Ghodsi, Hosein Esmaili Dezaki, Morteza Alizadeh, Zahra Namazi   +3 more
doaj  

Population scale data reveals the antidepressant effects of ketamine and other therapeutics approved for non-psychiatric indications. [PDF]

, 2017
Current therapeutic approaches to depression fail for millions of patients due to lag in clinical response and non-adherence. Here we provide new support for the antidepressant effect of an anesthetic drug, ketamine, by Inverse-Frequency Analysis of ...
Abagyan, Ruben, Atayee, Rabia, Cohen, Isaac V, Makunts, Tigran   +3 more
core   +2 more sources