Fibrosing colonopathy associated with cysteamine bitartrate delayed-release capsules in cystinosis patients.

Background: The objective of this report is to identify and characterize cases of fibrosing colonopathy, a rare and underrecognized adverse event, associated with cysteamine delayed-release (DR) in patients with nephropathic cystinosis.

Methods: We searched the U.S.

Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study.

Introduction: The Food and Drug Administration Adverse Event Reporting System (FAERS) is a vital source of new drug safety information, but whether adverse event (AE) information collected from these systems adequately captures experiences of the overall United States (US) population is unknown.

Objective: To examine determinants of consumer AE reporting in the USA.

Methods: Five-year AE reporting rate per 100,000 residents per US county were calculated, mapped, and quartiled for AE reports received directly from consumers between 2011 and 2015.

Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010-2020: A Cross-Sectional Study.

Introduction: The Food and Drug Administration Adverse Event Reporting System (FAERS) is a database of adverse event (AE) and medication error reports for drugs and therapeutic biologics. Examining trends of reported individual case safety reports (ICSRs) provides context for evaluating safety concerns.

Objective: Characterize pediatric FAERS ICSRs and compare trends (1) to adult reports; (2) within pediatric subgroups.

Leveraging Case Narratives to Enhance Patient Age Ascertainment from Adverse Event Reports.

Introduction: Missing age presents a significant challenge when evaluating individual case safety reports (ICSRs) in the FDA Adverse Event Reporting System (FAERS). When age is missing in an ICSR's structured field, it may be in the report's free-text narrative.

Objectives: This study aimed to evaluate the performance and assess the potential impact of a rule-based natural language processing (NLP) tool that utilizes a text string search to identify patients' numerical age from unstructured narratives.

Feature engineering and machine learning for causality assessment in pharmacovigilance: Lessons learned from application to the FDA Adverse Event Reporting System.

Background: Our objective was to support the automated classification of Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) reports for their usefulness in assessing the possibility of a causal relationship between a drug product and an adverse event.

Method: We used a data set of 326 redacted FAERS reports that was previously annotated using a modified version of the World Health Organization-Uppsala Monitoring Centre criteria for drug causality assessment by a group of SEs at the FDA and supported a similar study on the classification of reports using supervised machine learning and text engineering methods. We explored many potential features, including the incorporation of natural language processing on report text and information from external data sources, for supervised learning and developed models for predicting the classification status of reports.

Complementary Use of U.S. FDA's Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants-Associated Cutaneous Small Vessel Vasculitis.

Background: Cutaneous small vessel vasculitis (CSVV) has been reported after exposure to direct oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban, and edoxaban.

Objective: We used the U.S.

An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System.

Introduction: Adverse reactions with an outcome of death are inherently important for pharmacovigilance organizations to evaluate. Prior efforts to systematically evaluate individual case safety reports (ICSRs) with an outcome of death have been limited to high-level summaries.

Objective: The aim of this study was to characterize ICSRs with an outcome of death contained in the US FDA Adverse Event Reporting System (FAERS) database.

Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility.

Introduction: The rapidly expanding size of the Food and Drug Administration's (FDA) Adverse Event Reporting System database requires modernized pharmacovigilance practices. Techniques to systematically identify high utility individual case safety reports (ICSRs) will support safety signal management.

Objectives: The aim of this study was to develop and validate a model predictive of an ICSR's pharmacovigilance utility (PVU).

Impact of a New Consumer Form on the Quantity and Quality of Adverse Event Reports Submitted to the United States Food and Drug Administration.

Study Objective: Consumers and healthcare professionals can voluntarily report adverse experiences associated with drug products to the United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS). Consumers and healthcare professionals used the same general voluntary reporting form (GVR) until mid-2013, when a consumer voluntary reporting form (ConVR), written in plain language, was implemented. The objective of this study was to examine the effect of the ConVR on the quality and quantity of consumer reports submitted directly to FAERS.

Predicting medication-associated altered mental status in hospitalized patients: Development and validation of a risk model.

Purpose: This study presents a medication-associated altered mental status (AMS) risk model for real-time implementation in inpatient electronic health record (EHR) systems.

Methods: We utilized a retrospective cohort of patients admitted to 2 large hospitals between January 2012 and October 2013. The study population included admitted patients aged ≥18 years with exposure to an AMS risk-inducing medication within the first 5 hospitalization days.

Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance.

Introduction And Objective: Adverse event reports from industry-sponsored programs, such as patient support programs, have contributed to a rise in the number of individual case safety reports in the US Food and Drug Administration Adverse Event Reporting System database. This study aimed to characterize individual case safety reports from industry-sponsored program and non-industry-sponsored program sources and compare their usefulness in safety signal detection.

Methods: Individual case safety reports of six drug and biological products were identified in the Food and Drug Administration Adverse Event Reporting System database between the date of Food and Drug Administration product approval and the first quarter of 2017.

An Evaluation of "Drug Ineffective" Postmarketing Reports in Drug Safety Surveillance.

Introduction: The most commonly reported adverse event, based on frequency of Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs), in the US FDA Adverse Event Reporting System (FAERS) database is "drug ineffective" (DI). This study aimed to describe the DI reports and provide data to support recommendations on how to best evaluate these reports.

Methods: We characterized all FAERS reports coded with the MedDRA PT "drug ineffective" received between 1 September 2012 and 31 August 2016 using all other FAERS reports as a comparator.

Liver injury associated with dimethyl fumarate in multiple sclerosis patients.

Background: In pre-approval trials, there was an increased incidence of mild, transient elevations of liver aminotransferases in study subjects treated with dimethyl fumarate (DMF).

Objective/methods: To evaluate post-marketing cases of drug-induced liver injury associated with DMF.

Results: We identified 14 post-marketing cases of clinically significant liver injury.

Comparative effectiveness of fish oil versus fenofibrate, gemfibrozil, and atorvastatin on lowering triglyceride levels among HIV-infected patients in routine clinical care.

Objective: The goal of this study was to compare the effectiveness of fish oil, fenofibrate, gemfibrozil, and atorvastatin on reducing triglyceride (TG) levels among a large cohort of HIV-infected patients in clinical care.

Design: Retrospective observational cohort study.

Methods: The primary endpoint was absolute change in TG levels measured using the last TG value pretreatment and the first TG value posttreatment.

Pravastatin versus simvastatin for prevention of contrast-induced nephropathy.

Contrast-induced nephropathy (CIN) is associated with long-term morbidity, mortality, and increased health care costs. It has been suggested that statins have pleiotropic effects countering inflammatory and oxidative stress involved in CIN. Several studies support this theory; however, previously published studies have not evaluated the potential differences between statins in reducing the incidence of CIN.