Reporting System Data Research Articles

A descriptive study of fatal drownings among children and adolescents in the United States, with a focus on retention pond deaths, 2004-2020.

The objective of this study was to characterize fatal drownings among children and adolescents, with a focus on retention pond drownings, and identify risk factors for these fatalities using child death review data. We acquired 2004-2020 National Fatality Review-Case Reporting System data for drowning deaths among youth 0-19 years. Retention pond drownings were identified through case narratives. We analyzed demographics, primary caregiver, supervisor, death investigation, and drowning-related variables across age groups (<1, 1-4, 5-9, 10-14, and 15-19 years) using either the Chi-square test or Fisher's Exact test, as appropriate, with a p-value of <0.05 indicating statistical significance. Of 7,539 drowning deaths reported during the study duration, 265 deaths occurred in retention ponds. Children 1-4 years comprised a greater proportion of retention pond drowning deaths (59.3%) compared to overall drowning deaths (50.9%) in this age group. In 51.3% of retention pond drowning deaths among children <5 years, supervision was needed but not provided. Most (80.4%) retention pond-related deaths among children <5 years and 50.7% of deaths among children 5-19 years were attributed to child neglect, poor or absent supervision, or exposure to hazards. Among all decedents who drowned in retention ponds, 19.1% were found to have a disability or chronic illness. Most retention ponds lacked local ordinances regulating water access (83.5%) and did not have barriers or protection (66.1%) or warning signs (82.0%). Younger children with poor or absent supervision who cannot swim are at high risk of drowning. Retention pond drownings are not infrequent, and most locations lack ordinances regulating water access or requiring barriers, such as fences. Greater efforts are needed to address this common hazard and environmental and policy strategies should be implemented to prevent future deaths.

Unveiling the safety profile of lecanemab: A comprehensive analysis of adverse events using FDA adverse event reporting system data.

Lecanemab, a novel monoclonal antibody targeting amyloid-β, has shown promise in treating Alzheimer's disease. Comprehensive post-marketing safety data analysis is crucial to understand its real-world risk profile. This study aimed to evaluate the safety profile of lecanemab using data from the FDA Adverse Event Reporting System (FAERS), with a focus on nervous system disorders and amyloid-related imaging abnormalities. We conducted a disproportionality analysis using the FAERS database to evaluate the safety signals associated with lecanemab. Reporting odds ratio (ROR), proportional reporting ratio, empirical Bayesian geometric mean, and information component were calculated at both system organ class (SOC) and preferred term (PT) levels. Additionally, we performed a time-to-onset analysis using Weibull shape parameter estimation. Analysis at the SOC level revealed significant signals for nervous system disorders (ROR: 7.32, 95% CI: 6.69-8.00). At the PT level, strong signals were observed for amyloid-related imaging abnormalities, particularly those associated with microhemorrhages and oedema (ROR: 4122.81 and 3922.78, respectively). Headache was the most frequently reported adverse event (200 cases), followed by chills (107 cases) and fatigue (97 cases). Time-to-onset analysis showed a median time of 33 days (range: 1-1283) for all adverse events, with neurological events occurring slightly later (median: 42 days, range: 1-1260). Our findings highlight a distinct safety profile for lecanemab, with a predominant impact on the nervous system and a notable association with imaging abnormalities. These results underscore the importance of vigilant monitoring and further research to optimize the risk-benefit profile of lecanemab in clinical practice.

Real-world individual and comparative analysis of adverse event reporting for adalimumab and etanercept using public FDA adverse event reporting system data

Real-world individual and comparative analysis of adverse event reporting for adalimumab and etanercept using public FDA adverse event reporting system data

Safety evaluation of medroxyprogesterone acetate: a pharmacovigilance analysis using FDA adverse event reporting system data

BackgroundMedroxyprogesterone acetate (MPA), a synthetic progestogen, is extensively used for the treatment of various conditions, including contraception, irregular menstruation, functional uterine bleeding, and endometriosis. However, like all pharmaceutical agents, MPA is associated with adverse drug reactions. This study aimed to evaluate the adverse events (AEs) associated with MPA in by analyzing real-world data from the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS). By providing a comprehensive assessment of the safety profile of MPA, this study seeks to support informed clinical decision-making.MethodsData covering the period from the first quarter of 2004 to the first quarter of 2024 were collected from the FAERS database. Disproportionality analyses were conducted using several statistical methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayesian geometric mean (EBGM). Additionally, time-to-onset (TTO) analysis was employed to quantify the signals of the MPA-associated AEs.ResultsA comprehensive dataset comprising 21,035,995 AE reports was compiled. Among these, 3,939 women reported using MPA as a contraceptive method. The reports covered 27 system organ classes (SOCs) and 25 high-frequency AE signals. Notably, significant AEs were identified, some of which were not previously detailed in the medication’s prescribing information. Unforeseen significant AEs such as unintended pregnancy (n = 623; ROR, 6.65; ROR025, 6.1; χ2, 2,482.38; PRR, 6.41; EBGM, 5.69; EBGM05, 5.29), bone pain (n = 35; ROR, 13.78; ROR025, 9.4; χ2, 311.2; PRR, 13.75; EBGM, 10.59; EBGM05, 7.69), gait disturbance (n = 34; ROR, 2.82; ROR025, 1.99; χ2, 37.31; PRR, 2.88; EBGM, 2.7; EBGM05, 2.02), dental caries (n = 15; ROR, 23.16; ROR025, 12.32; χ2, 204.26; PRR, 23.14; EBGM, 15.23; EBGM05, 8.98), decrease in blood pressure (n = 15; ROR, 3.88; ROR025, 2.29; χ2, 29.35; PRR, 3.88; EBGM, 3.63; EBGM05, 2.33), and osteonecrosis (n = 9; ROR, 23.44; ROR025, 10.36; χ2, 123.67; PRR, 23.43; EBGM, 15.35; EBGM05, 7.75) were identified as AEs that were not previously outlined in the prescribing information of the medication.ConclusionOur findings align with clinical observations, highlighting the emergence of previously unreported AE signals associated with MPA and their demographic and TTO characteristics. Further pharmaco-epidemiological studies are required to substantiate these observations.

Detection of Illegally Manufactured Fentanyls and Carfentanil in Drug Overdose Deaths - United States, 2021-2024.

During 2023, approximately 72,000, or nearly seven in 10, drug overdose deaths in the United States were estimated to involve illegally manufactured fentanyls (IMFs). Carfentanil, a fentanyl analog 100 times more potent than fentanyl, has reemerged in the U.S. drug supply. Using CDC's State Unintentional Drug Overdose Reporting System data, this report describes trends in overdose deaths during January 2021-June 2024, overall and with IMFs detected, by U.S. Census Bureau region, and in deaths with carfentanil detected, in 45 states and the District of Columbia (DC). Numbers of deaths with carfentanil detected by state during January 2023-June 2024 in 49 states and DC are also reported. The number of overdose deaths with IMFs detected declined from 2022 to 2023 in the Northeast (3.2% decline), Midwest (7.8%), and South (2.8%) regions; deaths in the West increased 33.9%. The percentage of deaths with IMFs detected was steady at approximately 70%-80% in the Northeast, Midwest, and South. In contrast, the percentage of deaths with IMFs detected in the West increased from 48.5% during January-March 2021 to 66.5% during April-June 2024. Overdose deaths with carfentanil detected increased approximately sevenfold, from 29 during January-June 2023 to 238 during January-June 2024; during January 2023-June 2024, overdose deaths with carfentanil detected were reported in 37 states. Overdose prevention efforts that address the widespread presence of IMFs, including carfentanil, and can rapidly adapt to other potent opioids in the drug supply might result in lasting reductions in overdose deaths across the entire United States.

Race adjustment hides and perpetuates systemic racism: Real world example using life tables.

Extant research shows that race adjustment in epidemiologic analyses could lead to masking of systemic racism. In this study, we compare race-adjusted and -unadjusted years of life lost (YLL), a measure of societal burden, to understand the impact of race adjustment in YLL estimation. We used North Carolina (NC) Violent Death Reporting System data from 2006-2019 linked to 2006-2019 race-adjusted and -unadjusted life tables from the Centers for Disease Control and Prevention by calendar year and age at death. We calculated total YLL and YLL per death from suicide and homicide deaths for non-Hispanic black and non-Hispanic white NC residents using both the race-adjusted and -unadjusted life tables. We found that YLL and YLL/death from suicide and homicide deaths for non-Hispanic white individuals were almost identical regardless of race adjustment. However, race-adjusted life tables vastly underestimated total YLL and YLL per death for non-Hispanic black NC residents. Overall, race adjustment resulted in an underestimation of 14,907 YLL from homicide deaths (3.1 fewer YLL/death) and 4,414 YLL from suicide deaths (2.8 YLL/death) for black NC residents. Our study shows that the baked-in underestimation of YLL for non-Hispanic Black Americans when using race-adjusted life tables hides racialized health disparity and perpetuates inequity.

Diagnostic performance of adult-based thyroid imaging reporting and data systems in pediatric thyroid carcinoma: a retrospective study

BackgroundThyroid nodules diagnosed in children pose a greater risk of malignancy compared to those in adults. However, there is no ultrasound thyroid nodule evaluation system aimed at children. The objective of this research is to assess the diagnostic performance of the adult-based American College of Radiology Thyroid Imaging Reporting and Data System (ACR-TIRADS) and Chinese Thyroid Imaging Reporting and Data System (C-TIRADS) in pediatric thyroid carcinoma.MethodsThe preoperative ultrasound images of 177 thyroid lesions in 136 pediatric patients aged 18 or younger who underwent thyroid surgery or fine needle aspiration (FNA) at our center from July 2017 to July 2022 were reviewed. The sonographic characteristics of pediatric thyroid carcinoma were compared and analyzed in contrast to benign nodules. All the nodules were evaluated by the ACR-TIRADS and the C-TIRADS respectively.ResultsUltrasound features such as solid composition (94.8%), hypoechogenicity or marked hypoechogenicity (94.8-95.7%) and microcalcification (78.3-84.3%) were more common in pediatric malignant nodules (P-values < 0.05). The areas under receiver operating characteristic curves (AUC) of the ACR-TIRADS and the C-TIRADS in diagnosing pediatric thyroid carcinoma were 0.903–0.906, 0.907–0.909 (P-value > 0.05). The interobserver agreement of both the ACR-TIRADS and the C-TIRADS was strong (weighted Kappa > 0.90).ConclusionsBoth the C-TIRADS and the ACR-TIRADS owned great diagnostic performance and strong interobserver agreement in diagnosing pediatric thyroid carcinoma. However, a more complete and specific ultrasound evaluation system for pediatric thyroid nodules is still needed.

A Descriptive Analysis of Siblicide: Examining Ten Years of Incidents Reported in the National Incident-Based Reporting System (NIBRS), 2013–2022

ABSTRACT Siblicide, the killing of one sibling at the hands of another, is an extreme act along the arc of sibling violence, situated within the family violence paradigm. Purpose: Siblicide in the human population remains poorly understood and under-examined in need of contemporary baseline descriptive profiles examining victim, offender, and incident-level characteristics to develop a new base of knowledge, without age or sex limitations, to facilitate future research and practice opportunities including intervention, prevention, and policy. Methods: The study draws on 10 years of officially reported siblicide in National Incident-Based Reporting System (NIBRS) data, 2013–2022, (N = 862). Results: Analyses suggest siblicide is more frequent among adult siblings than youth siblings. Fratricides are more prevalent than sororicides and more likely to include a firearm and result from an argument. Sororicides are more likely to include multiple offenders and/or victims. Conclusion: Assessing large-scale data to better understand the scope and scale of the problem, including the nexus of victims, offenders, and incident criteria, is an important step toward a framework of knowledge to facilitate micro-level study within the family dynamic leading to early intervention and prevention of siblicide.

Off-Label Use of Monoclonal Antibodies for Eosinophilic Esophagitis in Humans: A Scoping Review.

Background: Eosinophilic esophagitis (EoE) is a rare, chronic immune-mediated disorder with limited treatment options. Despite the U.S. Food and Drug Administration (FDA) approval of dupilumab for EoE, other monoclonal antibodies remain unapproved and are used off-label with limited evidence on their efficacy and safety. This systematic review rigorously and comprehensively evaluates the evidence for monoclonal antibody therapies used off-label to treat EoE. Methods: We conducted a systematic review across PubMed, EMBASE, Cochrane Central, and ClinicalTrials.gov, assessing the efficacy and safety of off-label monoclonal antibodies in EoE through clinical outcomes and the FDA Adverse Event Reporting System (FAERS) data. Results: Among ten monoclonal antibodies reviewed, mepolizumab that targets IL-5 showed the most promise with a moderate recommendation based on Level 2 evidence. Others like omalizumab (anti-IgE), dectrekumab (anti-IL-13), and reslizumab (anti-IL-5) showed limited utility. Safety evaluations via the FAERS database revealed significant adverse drug reactions, including serious events like asthmatic crises, pneumonia, and adrenal insufficiency for mepolizumab and reslizumab, as well as chronic obstructive pulmonary disease and gastroenteritis for omalizumab. Dectrekumab's safety profile remains unclear due to a lack of data. Conclusions: While mepolizumab demonstrates potential as an off-label treatment, none of the antibodies reviewed have FDA approval for EoE. Clinicians should consider the balance between local and systemic effects and exercise caution, closely monitoring for adverse effects, particularly in patients with respiratory comorbidities. Continued research is crucial to establish a more robust evidence base for these therapies.

The Effect of Race and Sex on Contact Sex Crime Arrest Odds

ABSTRACTThis article investigates how the intersection of race and sex affects contact sex crime arrest odds. Logistic regression analyses of 2012–2016 U.S. National Incident‐Based Reporting System data for 391,352 people reported to law enforcement for contact sex crimes reveals that Black people reported for contact sex crimes have higher odds of arrest than those reported who are not Black, and the relationship between race and arrest odds varies by sex—the effect is stronger for those labeled “female” or “other” and weaker for those labeled “male.” I posit that sex strengthens the effect of race on contact sex crime arrest odds for those who are not male because race helps construct non‐male bodies as masculine, and in a U.S. cultural context that has viewed sex as a legitimate way of asserting male dominance, sexual violence is masculine. However, race is not necessary to construct most male bodies as masculine, making the strength of race's effect on contact sex crime arrest odds less significant for males.

Characteristics of Fatalities Among Sexual- and Gender-Diverse Youth in the United States: 2015-2020.

Sexual- and gender-diverse youth face unique stressors that negatively impact their health. The objective of this study was to use National Fatality Review-Case Reporting System data to epidemiologically describe fatalities among identified sexual- and gender-diverse youth to inform future prevention efforts. We used 2015 to 2020 data from the National Fatality Review-Case Reporting System to identify deaths among sexual- and gender-diverse youth and compare their characteristics to a matched sample of youth from these same data who were not known to be sexual- and gender-diverse. Demographic, injury, death, history, and life stressor characteristics were analyzed using descriptive statistics. During the study period, 176 fatalities were identified among sexual- and gender-diverse youth. Decedents' mean age was 15.3 years. A greater proportion of deaths was attributed to suicide among sexual- and gender-diverse youth (81%) compared with nonsexual- and gender-diverse youth (54%). Receiving prior (69%) and/or current (49%) mental health services was more common among sexual- and gender-diverse youth, compared with nonsexual- and gender-diverse youth (50% and 31%, respectively). Sexual- and gender-diverse youth were significantly more likely to experience problems in school or be victims of bullying, compared with nonsexual- and gender-diverse youth (63% versus 47% and 28% versus 15%, respectively). Suicide was the most common manner of death for sexual- and gender-diverse youth, despite many decedents receiving current or prior mental health services. These findings indicate the need to improve and diversify interventions to prevent these deaths.

A Pharmacovigilance Study of the Association between Antineoplastic Agents and Neutropenia Adverse Events Based on Food and Drug Administration Adverse Event Reporting System Data

Neutropenia is one of the most common adverse events associated with antineoplastic agents. However, comprehensive real-world studies on the relationship between antineoplastic agents and neutropenia are relatively scarce.

Characterising fire or burn-related fatalities in the USA using the National Violent Death Reporting System, 2003–2020

ObjectivesIntentional fire or burn-related deaths are rare in the USA compared with some countries, but do occur, and our knowledge of their epidemiology is limited. The objective of this study...

Cardiovascular adverse events associated with norepinephrine-dopamine reuptake inhibitors: a pharmacovigilance study of the FDA Adverse Event Reporting System.

Norepinephrine-dopamine reputake inhibitors (NDRIs), including bupropion, methylphenidate, atomoxetine, and reboxetine, are commonly prescribed for psychiatric disorders such as narcolepsy, attention-deficit/hyperactivity disorder, and depression. Cardiovascular adverse events have been reported to the FDA despite their effectiveness. This pharmacovigilance study analyzed cardiovascular adverse events associated with NDRIs using the FDA Adverse Event Reporting System data from January 2004 to December 2021. A retrospective analysis of adverse event reports was conducted, employing time-trend analysis and disproportionality evaluation to assess cardiovascular risks. Bupropion had the greatest reported odds ratios (RORs) for tachycardia (ROR=4.2, 95% CI: 4.0-4.4) and hypertension (ROR=3.5, 95% CI: 3.3-3.7), while methylphenidate showed greater ROR for arrhythmias (ROR=2.8, 95% CI: 2.6-3.0) and palpitations (ROR=3.1, 95% CI: 2.9-3.3). Reboxetine had signals for palpitations (ROR=3.0, 95% CI: 2.8-3.2) and myocardial infarction (ROR=2.7, 95% CI: 2.5-2.9), whereas atomoxetine revealed signals for hypertension (ROR=2.9, 95% CI: 2.7-3.1) and syncope (ROR=2.5, 95% CI: 2.3-2.7). Time-trend analysis revealed temporal variability in the cardiovascular risks connected with NDRIs. Our research elucidates cardiovascular safety profiles for NDRIs, highlighting the necessity for continuous pharmacovigilance. The observed variations in adverse events emphasize the need for ongoing surveillance to mitigate potential cardiovascular risks and enhance patient safety and treatment outcomes.

A natural language processing approach to detect inconsistencies in death investigation notes attributing suicide circumstances

BackgroundData accuracy is essential for scientific research and policy development. The National Violent Death Reporting System (NVDRS) data is widely used for discovering the patterns and causing factors of death. Recent studies suggested the annotation inconsistencies within the NVDRS and the potential impact on erroneous suicide-circumstance attributions.MethodsWe present an empirical Natural Language Processing (NLP) approach to detect annotation inconsistencies and adopt a cross-validation-like paradigm to identify possible label errors. We analyzed 267,804 suicide death incidents between 2003 and 2020 from the NVDRS. We measured annotation inconsistency by the degree of changes in the F-1 score.ResultsOur results show that incorporating the target state’s data into training the suicide-circumstance classifier brings an increase of 5.4% to the F-1 score on the target state’s test set and a decrease of 1.1% on other states’ test set.ConclusionsTo conclude, we present an NLP framework to detect the annotation inconsistencies, show the effectiveness of identifying and rectifying possible label errors, and eventually propose an improvement solution to improve the coding consistency of human annotators.

Co-occurrence of Intimate Partner Violence and Suicide Mortality Among Adolescents and Young Adults in the United States

PurposeSuicide is the second leading cause of death among people ages 10–24 in the United States (US). Intimate partner violence (IPV) is also prevalent, and studies suggest that IPV is associated with youth suicide risk. However, limited research has investigated such associations. We conducted an in-depth analysis of youth suicides that were preceded by or coincided with IPV (i.e., IPV-related) to characterize how decedents were involved in IPV, IPV types experienced, and prior legal systems involvement. MethodsUsing US National Violent Death Reporting System (2014–2018) data for suicide decedents aged 7–24 (n = 15,430 deaths), we manually reviewed case narratives for IPV-related suicides (n = 882) and coded details concerning IPV circumstances. We conducted bivariate analyses to compare IPV-related suicides to other (non-IPV) youth suicides and examined differences in antecedent circumstances between IPV perpetrators (n = 651) and victims (n = 81) using multivariable logistic regression. ResultsAmong IPV-related suicides, most decedents were male and were described as IPV perpetrators. Physical IPV was most frequently reported. Compared to decedents with a history of IPV perpetration, decedents with a history of IPV victimization were more often female and younger. Narratives of IPV victim decedents had higher odds of reporting physical IPV; narratives of IPV perpetrator decedents had higher odds of reporting psychological IPV. DiscussionFuture research should explore the relationship between IPV perpetration and suicide and potential impacts on surviving partners. Research and practice should seek to develop effective assessments and interventions for young people that address IPV and suicide risk simultaneously.

Role of the Built Environment, Roadway Characteristics, and Socioeconomic Factors in Keeping Teen Drivers Safe: An Investigation of the Factors Most Related to Teen Driver Fatalities

The role of engineering, through infrastructure design, is known to influence safe driving behavior generally, yet the areas of possible intervention that could improve safe outcomes for teens are less understood. It is critical to identify interventions specific to teens, as they have different driving risk factors than more seasoned drivers, and motor vehicle crashes are the second leading cause of death among teens in the United States. We examined 5,210 fatal crashes from 2015 to 2019 in Ohio using Fatality Analysis Reporting System data. We employed multinomial logistic regression to associate the likelihood of fatal crashes involving younger teens (16 to 17 years old) or older teens (18 to 19 years old) relative to adults (20 years and older) with built environment, socioeconomic, and roadway characteristics at crash locations. Separating crashes into the two groups of teens allowed us to distinguish the possible impact of training, as younger teens are mandated to undergo driving education and behind-the-wheel training under Ohio’s graduated driver licensing laws. We found that compared with neighborhood socioeconomics, built environment factors were more significant predictors of the likelihood of fatal crashes involving younger teens compared with adults. Specifically, fatal crashes at locations with lower road density and more diverse land use were more likely to involve younger teens. Although these results could be related to a mix of younger teen driver behavior and exposure factors, the finding highlights that improving the safety of local roads in urban and rural settings could help stem teen driving fatalities.

ORENITRAM’s decadal journey: unveiling safety profiles and adverse event through a real-world pharmacovigilance study of FAERS events

ABSTRACT Background ORENITRAM, an oral treprostinil formulation, was approved in 2013 for pulmonary arterial hypertension (PAH) treatment, necessitating ongoing safety monitoring. Research design and methods This retrospective analysis used FDA Adverse Event Reporting System data from Q4 2013 to Q4 2023, employing disproportionality analysis and the reporting odds ratio (ROR) to identify adverse events (AEs) linked with ORENITRAM. Results Out of 15,660,695 reports, ORENITRAM was the primary suspect in 10,125 cases. We identified 174 significant adverse events across 27 organ systems, with notable issues like pulmonary edema, ascites, and ventricular fibrillation. Females reported more AEs (75.6%) than males (24.0%), suggesting potential metabolic differences. AEs were most common within 30 days of starting treatment or after one year. Conclusions The study indicates significant safety issues with ORENITRAM, including serious unexpected events such as pulmonary edema, ascites, and ventricular fibrillation. These findings highlight the necessity for careful clinical monitoring and effective risk management, particularly with observed gender differences in AE profiles. The study’s retrospective nature and reliance on spontaneous reports may affect result generalizability.

GI-RADS versus O-RADS in the differential diagnosis of adnexal masses: a systematic review and head-to-head meta-analysis.

The aim of this study was to compare the diagnostic performance of the Gynecology Imaging Reporting and Data System (GI-RADS) and Ovarian-Adnexal Reporting and Data System (O-RADS) ultrasound (US) classification systems and assess their capacity to stratify the risk of malignancy in adnexal masses (AMs). A comprehensive search of MEDLINE (PubMed), Scopus, Web of Science, and Google Scholar was conducted to identify articles published between January 2020 and August 2023. The quality of the studies, the risk of bias, and concerns regarding applicability were assessed using QUADAS-2. The search yielded 132 citations. Five articles, which included a total of 2,448 AMs, were ultimately selected for inclusion. The risk of bias was high in all articles regarding patient selection, low in four studies for the index test, and unclear in three papers for the reference test. For GI-RADS, the pooled sensitivity and specificity were 90.8% (95% confidence interval [CI], 86.0% to 94.0%) and 91.5% (95% CI, 89.0% to 93.0%), respectively. For O-RADS, the pooled sensitivity and specificity were 95.1% (95% CI, 93.0% to 97.0%) and 88.8% (95% CI, 85.0% to 92.0%), respectively. O-RADS demonstrated greater sensitivity for malignancy than GI-RADS (P<0.05). Heterogeneity was moderate for both sensitivity and specificity with respect to GIRADS; for O-RADS, heterogeneity was moderate for sensitivity and high for specificity. Both GI-RADS and O-RADS US demonstrate good diagnostic performance in the preoperative assessment of AMs. However, the O-RADS classification provides superior sensitivity.

Pregnancy related adverse events and congenital disorders associated with fluoroquinolones: A real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS)

BackgroundFluoroquinolones, including ciprofloxacin, levofloxacin, and moxifloxacin, are extensively employed as broad-spectrum antibacterial agents. However, their use is discouraged during pregnancy due to potential adverse events (AEs). The aim of this study is to systematically investigate the association between fluoroquinolones (specifically ciprofloxacin, levofloxacin, and moxifloxacin) and AEs related to pregnancy, as well as their potential impact on congenital disorders. MethodsA disproportionality analysis was conducted utilizing FDA Adverse Event Reporting System (FAERS) data spanning from the first quarter of 2004 to September 2023. The objective was to identify potential AEs signatures associated with fluoroquinolones through conducting reporting odds ratios (RORs) and Bayesian confidence propagation neural networks (BCPNN). Assessing the potential risk of pregnancy-associated AEs involved comparing each fluoroquinolone with all other medications. Additionally, in-depth comparative analyses were carried out between various fluoroquinolones and a reference drug (azithromycin). ResultsA total of 1159 cases were identified, involving AEs related to pregnancy and congenital disorders. Obvious disproportionate association of abortion spontaneous and other nine AEs was identified for fluoroquinolone during gestation. Upon comparison with all the other drugs, ciprofloxacin exhibited an elevated risk of spontaneous abortion, non-site specific bone disorders congenital and 10 other significant signals. Levofloxacin demonstrated an increased risk of congenital tongue disorders and three other significant signals. Moxifloxacin displayed a noteworthy signal indicating multiple congenital cardiac abnormalities. ConclusionsWe present compelling evidence regarding pregnancy-related AEs and congenital disorders linked to fluoroquinolones. Considering perinatal and genotoxicity aspects, we explore whether levofloxacin or moxifloxacin might be preferable when fluoroquinolones are deemed necessary to balance the benefits of pregnant women and fetuses.