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Others, like the markers for La Matanza in Cameron County and the Slocum massacre in Anderson County, showed that historical markers can provide opportunities for communities to publicly condemn racial violence at the hands of vigilantes and law enforcement officers. The horrific details of the tragedy were well documented, but the history had long been suppressed.2 At 2 a.m. on January 28, 1918, Company B of the Texas Rangers, soldiers from the Eighth US Cavalry Regiment, and four local ranchmen surrounded the residents of Porvenir, a rural ranching community on the Texas-Mexico border. [...]testimonies from the survivors, letters from US soldiers, investigations by US attorneys and Mexican diplomats, and confessions by Rangers and Anglo civilians ultimately forced the state to dismiss five Texas Rangers, disband Company B, and force Captain James M. Fox to resign. [...]the culture of impunity enjoyed by federal, state, and local law enforcement in the past is pervasive today.

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. Food and Drug Administration Adverse Event Reporting System (FAERS) and the medical literature for postmarketing reports of fibrosing colonopathy associated with cysteamine through August 2, 2023. Results We identified four cases of fibrosing colonopathy reported with the use of cysteamine DR. The time to onset ranged from 12 to 31 months. In one case, the patient required surgery to have a resection of a section of the strictured colon and a diverting ileostomy. Fibrosing colonopathy was diagnosed by histopathology in two of the cases. Conclusions Our case series identified the risk of fibrosing colonopathy in patients taking cysteamine DR and prompted regulatory action by the FDA. As outlined in changes to the U.S. prescribing information for cysteamine DR, healthcare professionals should be aware of the potential risk of fibrosing colonopathy with cysteamine DR, especially as symptoms can be non-specific leading to misdiagnosis or delayed diagnosis. If the diagnosis of fibrosing colonopathy is confirmed, consideration should be given to permanently discontinuing cysteamine DR and switching to cysteamine immediate-release treatment. Graphical abstract A higher resolution version of the Graphical abstract is available as Supplementary information

This article discusses new digital research projects by historians, sociologists, and legal scholars that recover previously unrecorded cases of racist violence in the twentieth century and bring them into public view for the first time. New cases are expanding current understandings of the past by documenting lynchings, racially motivated homicides, police killings, church bombings, and nonlethal types of violence that have targeted multiple racial and ethnic groups. Early findings from these projects show that we only have a glimpse into widespread practices of racial terror in the United States. I argue for collecting broader sets of data about victims, surviving relatives, aggressors, and events in the aftermath of violence, because doing so will create new possibilities for studying widespread historical trauma, institutional traces of racist violence, and public understanding of increasingly urgent historical lessons. To keep the humanity of victims central to recovery efforts, I suggest that researchers can learn from community preservation and memorialization practices.

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. Methods This cross-sectional study examined FAERS ICSRs received between January 1, 2010, through December 31, 2020. Stratified age bands were neonates, infants, younger children, older children, adolescents, and adults. We characterized groups by patient demographic information, suspect products, AEs, and reporter type. Results From 2010 to 2020, there were 11,258,995 FAERS ICSRs; 3.1% described pediatric patients. Compared to adults, pediatric ICSRs had higher proportions of all serious outcomes except death. Within pediatric subgroups, neonates had the highest proportions of serious outcomes (96.2%) compared to infants, younger children, older children, and adolescents (79.8%, 67.9%, 59.5%, and 52.7%, respectively). Younger pediatric age groups were more likely to have weight information than older age groups but were less likely to include gender information. The most frequently reported AE was off label use for pediatrics and drug ineffective for adults. Products and AEs reported also differed among pediatric subgroups. Neonates, infants, and adolescents had entirely distinct sets of top five product-event combinations. Conclusion Pediatric ICSRs represent a minority of FAERS reports but have distinctly different attributes relative to adult ICSRs. Reporting trends also vary within pediatric subgroups, which highlights the need for unique considerations for pediatric safety surveillance.

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. Associations between county-level sociodemographic factors obtained from County Health Rankings and AE reporting rates were evaluated using negative binomial regression. Results Reporting rates were variable across US counties with > 17.6 reports versus ≤ 5.5 reports/100,000 residents in the highest and lowest reporting quartile, respectively. Controlling for drug utilization, counties with higher reporting rates had higher proportions of individuals age ≥ 65 years (e.g., 2.4% reporting increase per 1% increase in individuals age > 65, incidence rate ratio (IRR): 1.024, 95% confidence interval (CI): 1.017–1.030), higher proportions of females (IRR: 1.027, 95% CI 1.012–1.043), uninsured (IRR: 1.009, 95% CI 1.005–1.013), higher median log household incomes (IRR: 1.897, 95% CI 1.644–2.189) and more mental health providers per 100,000 residents (IRR: 1.003, 95% CI 1.001–1.004). Lower reporting was observed in counties with higher proportions of individuals age ≤ 18 years (IRR: 0.966, 95% CI 0.959–0.974), American Indian or Alaska Native individuals (IRR: 0.991, 95% CI 0.986–0.996), individuals not proficient in English (IRR: 0.978, 95% CI 0.965–0.991), and individuals residing in rural areas within a county (IRR: 0.998, 95% CI 0.997–0.998). Conclusions Observed variations in consumer AE reporting may be related to sociodemographic factors and healthcare access. Because these factors may also correspond to AE susceptibility, voluntary AE reporting systems may be suboptimal for capturing emerging drug safety concerns among more vulnerable populations.

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. Methods All ICSRs received through 31 December 2017 reporting an outcome of death were characterized by patient demographics, suspect product(s), adverse events, and reporter type. Using the ICSR’s narrative and reporter information, we classified ICSRs by source to include those from industry-sponsored programs, poison control centers, specialty pharmacies, and litigation. Additionally, a random sample of ICSRs was evaluated for completeness of structured data fields and manually reviewed for the availability of key information in the narrative (i.e. cause of death, medical history, and causality assessment). Results Overall, 1,053,716 ICSRs with a death outcome were received in the study period. Ten medications treating conditions for malignancies, pain, and kidney disease accounted for nearly 20% of all fatal ICSRs. ICSRs originating from industry-sponsored programs, poison control centers, litigation, and specialty pharmacies accounted for 14%, 6.5%, 5.0%, and 3.3% of all fatal ICSRs, respectively. ICSRs in which the only adverse event coded was ‘death’ were more likely to be missing structured data and less likely to include key information in the narrative. Conclusion Understanding the origins and characteristics of ICSRs with an outcome of death supports meaningful evaluations and interpretations of FAERS data. A wide variability in ICSR quality exists, even in those reports with the most serious outcome.

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). Methods PVU was operationalized as an ICSR’s inclusion in an FDA-authored pharmacovigilance review’s case series supporting a recommendation to modify product labeling. Multivariable logistic regression models were used to examine the association between PVU and ICSR features. The best performing model was selected for bootstrapping validation. As a sensitivity analysis, we evaluated the model’s performance across subgroups of safety issues. Results We identified 10,381 ICSRs evaluated in 69 pharmacovigilance reviews, of which 2115 ICSRs were included in a case series. The strongest predictors of ICSR inclusion were reporting of a designated medical event (odds ratio (OR) 1.93, 95% CI 1.54–2.43) and positive dechallenge (OR 1.67, 95% CI 1.50–1.87). The strongest predictors of ICSR exclusion were death reported as the only outcome (OR 2.72, 95% CI 1.76–4.35), more than three suspect products (OR 2.69, 95% CI 2.23–3.24), and > 15 preferred terms reported (OR 2.69, 95% CI 1.90–3.82). The validated model showed modest discriminative ability ( C -statistic of 0.71). Our sensitivity analysis demonstrated heterogeneity in model performance by safety issue ( C -statistic range 0.58–0.74). Conclusions Our model demonstrated the feasibility of developing a tool predictive of ICSR utility. The model’s modest discriminative ability highlights opportunities for further enhancement and suggests algorithms tailored to safety issues may be beneficial.

Published online: 16 May 2019 © This is a U.S. government work and its text is not subject to copyright protection in the United States; however, its text may be subject to foreign copyright protection 2019 Dear Editor, Prescription drug litigation can result in concentrated influxes of reports submitted to the US FDA Adverse Event Reporting System (FAERS). SDRs for TD for atypical antipsychotics were also evaluated for comparison. Since 1998, the annual proportion of reports received classified as LARs has exceeded 1%, with the highest percentage occurring in 2005 (11%) following the withdrawal of rofecoxib. Effect of lawyer-submitted reports on signals of disproportional reporting in the food and drug administration's adverse event reporting system.

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. A random subset of industry-sponsored program and non-industry-sponsored program individual case safety reports were then compared to identify differences in reporters, outcomes, data completeness, and usefulness. The ‘usefulness’ of individual case safety reports was assessed by manually reviewing the availability of key information in the narrative (e.g., temporality, comorbidities). Results Compared with non-industry-sponsored program reports, more industry-sponsored program reports were associated with a serious outcome (51.4% vs. 58.8%, p  = 0.02) and were reported by consumers (35.5% vs. 50.4%, p  < 0.01). Industry-sponsored program reports tended to contain more data elements than non-industry-sponsored program reports (i.e., age, sex, indication for use), but completeness was variable across products. No significant difference in usefulness was identified between non-industry-sponsored program and industry-sponsored program individual case safety reports (30.6% vs. 28.5%, p  = 0.42). Useful reports that contained at least one serious, unlabeled adverse event represented only 4% and 6.2% of the non-industry-sponsored program and industry-sponsored program report cohorts, respectively. Conclusions Our study suggests that reports obtained from industry-sponsored programs in the Food and Drug Administration Adverse Event Reporting System database contain more data elements but are similar to non-industry-sponsored program reports with regard to ‘usefulness’ in signal detection.

To do this requires new methods of storytelling. Since 2014 I have been the primary investigator for a digital research project, Mapping Violence. [...]we needed a section where students could leave notes about contradictions in the archive, unanswered questions, and archival leads for future team members. [...]they redesigned a database entry form that could hold the additional metadata for each event and, simultaneously, hold the ambiguities of histories of racial violence. [...]each student wire framed a digital tour.