Results 71 to 80 of about 6,029 (168)
Recurrent fexuprazan‐induced liver injury following unintentional re‐exposure
British Journal of Clinical Pharmacology, Volume 91, Issue 11, Page 3266-3271, November 2025.Fexuprazan, a potassium‐competitive acid blocker, is increasingly used for the treatment of gastroesophageal reflux disease in South Korea. While generally well tolerated, data regarding its hepatotoxic potential are scarce. We report a case of idiosyncratic drug‐induced liver injury in a 61‐year‐old woman following 2 months of fexuprazan therapy.
Sook Jin Seong +5 more
wiley +1 more source
Therapeutics and Clinical Risk Management, 2016 Abdel Naser Zaid,1 Masshour Ghanem,2 Dua’a Shweiki,1 Hala Shtewi,1 Raja’ Shaheen,1 Sondos Al Helaly,1 Zeina Khayyat,1 Rowa’a Al Ramahi,1 Sa’ed H Zyoud1 1Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah ...
Zaid AN +8 more
doaj
Revista Brasileira de Saúde Materno Infantil, 2004 O objetivo desta revisão foi explorar e comparar as informações derivadas de estudos prospectivos sobre a incidência de reações adversas a medicamentos (RAM) em pediatria, publicados de janeiro de 1966 a novembro de 2003 em revistas indexadas nas bases ...
Djanilson Barbosa dos Santos +1 more
doaj +1 more source
Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices [PDF]
, 2011 Objective: To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices. Design: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices.
Brennan, Troyen Anthony +4 more
core +1 more source
A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]
, 2007 This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
core +1 more source
PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE [PDF]
, 2012 Objectives:High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US ...
Abrishami, P. +12 more
core +1 more source
FDA‐Approved Biologics for CRSwNP: A Five‐Year Analysis of the FDA Adverse Event Reporting System
Laryngoscope Investigative Otolaryngology, Volume 10, Issue 5, October 2025.Biologics are increasingly utilized in the treatment of chronic rhinosinusitis with nasal polyps. In this study, we characterized the adverse events reported in the FDA adverse event reporting system associated with each biologic to better understand who is at greatest risk for a serious adverse event.
Radhika Duggal, Mohamad R. Chaaban
wiley +1 more source
The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]
, 2018 Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D +6 more
core +2 more sources
Vitae: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment.
Patrícia de Carvalho Mastroianni +3 more
doaj +1 more source
Pulmonary Hypertension and Other Potentially Fatal Pulmonary Complications in Systemic Juvenile Idiopathic Arthritis [PDF]
, 2012 Objective Systemic juvenile idiopathic arthritis (JIA) is characterized by fevers, rash, and arthritis, for which interleukin‐1 (IL‐1) and IL‐6 inhibitors appear to be effective treatments.
Carol A. Wallace +19 more
core +1 more source