Adverse drug events associated with linezolid administration: a real-world pharmacovigilance study from 2004 to 2023 using the FAERS database
Ontology highlight
ABSTRACT:
SUBMITTER: Zou F
PROVIDER: S-EPMC10904462 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundCapecitabine, a prodrug of 5-fluorouracil, is extensively utilized for the treatment of metastatic breast cancer, colorectal cancer, and gastric cancer. Nevertheless, there exist limitations in comprehending adverse reactions (AEs) in clinical practice. In this study, we investigated the distribution of AEs associated with capecitabine and explored potential rare adverse reactions by mining the Food and Drug Administration Adverse Event Reporting System (FAERS).ObjectivesOur research aimed to explore the spectrum of AEs associated with capecitabine, including both documented and potential events, to provide a comprehensive understanding of the drug's safety profile and guide clinical practice. At the same time, it provides a new direction for further research on AEs associated with capecitabine in the future.DesignWe collected capecitabine-related adverse reactions from the FAERS and standardized the classification of AEs using the Medical Dictionary for Regulatory Activities 26.0. Four statistical schemes were used to analyze the obtained standardized signals.MethodsWe collected AEs reported for capecitabine from the FAERS between 2004 and 2023. To ensure standardized data, the collected reports related to capecitabine-associated adverse events were categorized using the preferred terms (PTs) and system organ classes (SOCs) classifications provided by the Medical Dictionary for Regulatory Activities 26.0. Statistical analysis involved the utilization of reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. Four statistical schemes were employed to analyze the adverse reactions associated with capecitabine. A positive signal was considered when all four schemes indicated an association with the adverse event.ResultsWe collected a total of 45,011 AEs associated with the use of capecitabine from the database, covering 27 SOCs from 2004 to 2023. The nine SOC categories with the highest number of events were identified, which include gastrointestinal disorders; general disorders and administration site conditions; skin and subcutaneous tissue disorders; nervous system disorders; investigations, injury, poisoning, and procedural complications; blood and lymphatic system disorders; metabolism and nutrition disorders; infections and infestations; and neoplasms benign, malignant, and unspecified (including cysts and polyps). Among these 27 SOCs, we identified seven SOCs that met the signal value criteria. Notably, we discovered AEs not mentioned in the instructions, including intestinal obstruction in gastrointestinal disorders, penetrating aortic ulcer in cardiac disorders, and non-cirrhotic portal hypertension in hepatobiliary disorders, all of which exhibited signals. Furthermore, 40.1% of AEs associated with the use of capecitabine occurred within the first 30 days.ConclusionOur study conducted a comprehensive analysis of capecitabine's AEs using the FAERS database. We identified previously unreported AEs, mitigating the risk for patients and ensuring safe drug administration.
| S-EPMC11660075 | biostudies-literature
Project description:BackgroundTeduglutide, the first glucagon-like peptide 2 analogue, has been demonstrated to facilitate the absorption of gut nutrient and lessen the need for parenteral assistance in patients with Short Bowel Syndrome (SBS). However, its adverse drug events (AEs) are primarily documented in clinical trials, with a deficit in real-world data. This study evaluates the AEs profile of teduglutide based on Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data.MethodA disproportionality analysis of FAERS data from Quarter 1 (Q1) 2013 to Quarter 3 (Q3) 2023 was conducted to examine the association between teduglutide and adverse events, employing Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) methods.ResultsOut of 13,809,302 reports in the FAERS database, 10,114 reports identified teduglutide as the "primary suspect" in AEs identification. During the dosing observation period, the median occurrence of adverse events was 393 days (interquartile range [IQR] 97-996 days). Teduglutide-associated AEs occurred in 27 System Organ Classes (SOC), of which renal and urinary disorders is not mentioned in the specification. Based on the four algorithms, a total of 260 major disproportionality preferred terms (PTs) were filtered out, including previously unreported AEs including weight decreased (n = 805), vascular device infection (n = 683), dehydration (n = 596) and nephrolithiasis (n = 146).ConclusionOur findings corroborate the AEs listed in the teduglutide prescribing information and additionally unveil new adverse reaction signals such as nephrolithiasis. These discoveries could aid in clinical monitoring and risk identification for teduglutide.
| S-EPMC11424547 | biostudies-literature
Project description:BackgroundRipretinib is a tyrosine kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with at least three kinase inhibitors. The objective of this study was to evaluate adverse events(AEs) associated with ripretinib using data from the FDA Adverse Event Reporting System (FAERS) database.MethodsIndividual case safety reports (ICSRs) related to of ripretinib from 2020 Q2 to 2024 Q2 were extracted from the FAERS database. This study used the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) for disproportionality analysis. In addition, this research also performed a descriptive analysis of the time-to-onset (TTO) of AEs related to ripretinib.ResultsA total of 3,513 ICSRs with ripretinib as the primary suspect (PS) were retrieved from the FAERS database. At the preferred term(PT) level, this study detected 116 positive AEs. Common AEs included alopecia, constipation, muscle spasms, dry skin, decreased appetite. Notably, unexpected AEs such as pleural mass, blood magnesium abnormal, blood potassium abnormal, hepatic lesion, and liver abscess were also observed. The median time to onset of ripretinib-related AEs was 102 days (29-254 days), with the majority of AEs occurring during the first month of treatment.ConclusionThis study identified some known AEs associated with ripretinib and discovered unexpected AEs, providing preliminary insights into its safety in the real world. This information is valuable for clinical monitoring and the safe use of ripretinib.
| S-EPMC11896992 | biostudies-literature
Project description:ObjectiveBased on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, we analyzed the signals of potential adverse events (AEs) of orlistat in the real world to provide a reference for its safe clinical use.MethodsThe FAERS database and OpenVigil 2.1 were used to obtain data on adverse events of orlistat from the first quarter of 2004 to the first quarter of 2023, and to analyze the population in which the adverse events occurred. And the signals of their potential adverse events were mined using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and empirical Bayesian geometric mean (EBGM).ResultA total of 21,079 reports of adverse events with orlistat as the primary suspected drug were collected in this study. Using four disproportionate analyses, we screened 117 preferred terms (PTs) involving 18 system organ classes (SOCs). We found that the most common adverse events at SOC level for orlistat remained "gastrointestinal disorders", while "metabolism and nutrition disorders", "renal and urinary disorders", "musculoskeletal and connective tissue disorders" and "hepatobiliary disorders" also ranked high in the number of case reports. In addition, at the PT level, we identified several new signals of adverse events not mentioned in the specification, including "lipiduria", "anal haemorrhage", "rectal haemorrhage", "haematochezia", "sigmoiditis", "diverticulitis" and "muscle spasms".ConclusionMost of the adverse events found in this study are consistent with the results described in the drug label. At the same time, we also found some new adverse events, which require more prospective studies to verify and elucidate their relationship with orlistat.
| S-EPMC11324990 | biostudies-literature
Project description:BackgroundDonepezil in combination with memantine is a widely used clinical therapy for moderate to severe dementia. However, real-world population data on the long-term safety of donepezil in combination with memantine are incomplete and variable. Therefore, the aim of this study was to analyze the adverse events (AEs) of donepezil in combination with memantine according to US Food and Drug Administration Adverse Event Reporting System (FAERS) data to provide evidence for the safety monitoring of this therapy.MethodsWe retrospectively analyzed reports of AEs associated with the combination of donepezil and memantine from 2004 to 2023 extracted from the FAERS database. Whether there was a significant association between donepezil and memantine combination therapy and AEs was assessed using four disproportionality analysis methods, namely, the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. To further investigate potential safety issues, we also analyzed differences and similarities in the time of onset and incidence of AEs stratified by sex and differences and similarities in the incidence of AEs stratified by age.ResultsOf the 2,400 adverse drug reaction (ADR) reports in which the combination of donepezil and memantine was the primary suspected drug, most of the affected patients were female (54.96%) and older than 65 years of age (79.08%). We identified 22 different system organ classes covering 100 AEs, including some common AEs such as dizziness and electrocardiogram PR prolongation; fall, pleurothotonus and myoclonus were AEs that were not listed on the drug label. Moreover, we obtained 88 reports of AEs in men and 100 reports of AEs in women; somnolence was a common AE in both men and women and was more common in women, whereas pleurothotonus was a more common AE in men. In addition, we analyzed 12 AEs in patients younger than 18 years, 16 in patients between 18 and 65 years, and 113 in patients older than 65 years. The three age groups had distinctive AEs, but lethargy was the common AE among all age groups. Finally, the median time to AE onset was 19 days in all cases. In both men and women, most AEs occurred within a month of starting donepezil plus memantine, but some continued after a year of treatment.ConclusionOur study identified potential and new AEs of donepezil in combination with memantine; some of these AEs were the same as in the specification, and some of the AE signals were not shown in the specification. In addition, there were sex and age differences in some of the AEs. Therefore, our findings may provide valuable insights for further studies on the safety of donepezil and memantine combination therapy, which are expected to contribute to the safe use of this therapy in clinical practice.
| S-EPMC11294921 | biostudies-literature
Project description:BackgroundSelpercatinib, a highly selective tyrosine kinase inhibitor, has emerged as an excellent treatment option for patients with rearranged during transfection-altered cancer. However, there is limited comprehensive safety information available for selpercatinib through large-scale post-marketing monitoring.MethodsThis study conducted a comprehensive analysis of selpercatinib-related adverse events (AEs) using the FDA Adverse Event Reporting System database. Four disproportionality methods were employed to identify potential AEs associated with selpercatinib. Specifically, this study investigated the differences in AEs of selpercatinib with respect to reporter continent, indication, sex, age, weight, dose, frequency, and onset time.ResultsA total of 464 reports and 1,007 selpercatinib-related AEs were identified. Three new significant AEs were discovered, including dysphagia, pericardial effusion, and hemiparesis. Notably, Asia reported hepatic function abnormal more frequently, especially in patient administered doses exceeding 160 mg. Furthermore, hypersensitivity was reported more frequently by Asia and in individuals weighing less than 50 kg.ConclusionsIt is paramount to stay vigilant concerning the potential emergence of three newly identified AEs. Significant differences were found in selpercatinib-related AEs concerning reporter continent, sex, weight, dose, frequency, and onset time, which deserved clinical attention. These findings contribute to a broader understanding of the AE profiles of selpercatinib.
| S-EPMC11613847 | biostudies-literature
Project description:BackgroundChimeric antigen receptor T-cell (CAR-T) therapy, a rapidly emerging treatment for cancer that has gained momentum since its approval by the FDA in 2017, involves the genetic engineering of patients' T cells to target tumors. Although significant therapeutic benefits have been observed, life-threatening adverse pulmonary events have been reported.MethodsUsing SAS 9.4 with MedDRA 26.1, we retrospectively analyzed data from the Food and Drug Administration's Adverse Event Reporting System (FAERS) database, covering the period from 2017 to 2023. The analysis included the Reporting Odds Ratio Proportional Reporting Ratio Information Component and Empirical Bayes Geometric Mean to assess the association between CAR-T cell therapy and adverse pulmonary events (PAEs).ResultsThe FAERS database recorded 9,400 adverse events (AEs) pertaining to CAR-T therapies, of which 940 (10%) were PAEs. Among these CAR-T cell-related AEs, hypoxia was the most frequently reported (344 cases), followed by respiratory failure (127 cases). Notably, different CAR-T cell treatments demonstrated varying degrees of association with PAEs. Specifically, Tisa-cel was associated with severe events including respiratory failure and hypoxia, whereas Axi-cel was strongly correlated with both hypoxia and tachypnea. Additionally, other CAR-T therapies, namely, Brexu-cel, Liso-cel, Ide-cel, and Cilta-cel, have also been linked to distinct PAEs. Notably, the majority of these PAEs occurred within the first 30 days post-treatment. The fatality rates varied among the different CAR-T therapies, with Tisa-cel exhibiting the highest fatality rate (43.6%), followed by Ide-cel (18.8%).ConclusionThis study comprehensively analyzed the PAEs reported in the FAERS database among recipients of CAR-T cell therapy, revealing conditions such as hypoxia, respiratory failure, pleural effusion, and atelectasis. These CAR-T cell therapy-associated events are clinically significant and merit the attention of clinicians and researchers.
| S-EPMC11371680 | biostudies-literature
Project description:Background and purpose: Testosterone is an essential sex hormone in maintaining masculine characteristics, which is prescribed for male hypogonadism as testosterone replacement treatment (TRT). Herein, we investigated long-standing controversies about the association between TRT and major adverse cardiovascular events (MACEs), based on real world adverse event (AE) reports, registered in the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Publicly available FAERS data from 1 January 2004 to 31 December 2022 were retrieved from the Food and Drug Administration (FDA) website. The data mining protocol including the reporting odds ratio (ROR) and the Bayesian confidence propagation neural network (BCPNN) was applied to analyze overreporting caused by risk factors and MACEs, including TRT, morbidities, and ages. The ROR and the BCPNN were also applied to investigate the annually developing trend of pharmacovigilance (PV) signals in the real world, retrospectively. Results: A total of 3,057 cases referring to MACEs, with a median age of 57 years old (yo), were identified from 28,921 cases of testosterone users. MACEs related to PV signals have emerged since 2014, including cardiac death, non-fatal myocardial infarction, and non-fatal stroke. Myocardial infarction (MI) (ROR: 9.46; IC025: 3.08), acute myocardial infarction (AMI) (ROR: 16.20; IC025: 3.72), ischemic cardiomyopathy (ROR: 11.63; IC025: 2.20), and cardiomyopathy (ROR: 5.98; IC025: 1.96) were the most significant signals generated, and weaker signals included cardiac failure acute (ROR: 4.01; IC025: 0.71), cardiac arrest (ROR: 1.88; IC025: 0.56), and ventricular fibrillation (VF) (ROR: 2.38; IC025: 0.38). The time-to-onset (TTO) of MACEs was calculated with a median of 246 days for AMI. Conclusion: For myocardial infarction and cardiomyopathy, TRT statistically tended to increase the risk of MACEs, while for cardiac arrhythmia, cardiac failure, and stroke, TRT demonstrated beneficial effects among the population with morbidities, such as testosterone deficiency (TD), diabetes mellitus (DM), and hypertension. MACEs were rare but led to serious outcomes including significant increase in death and disability. Since 2018, and before 2014, reports referring to TRT associated with MACEs were relatively scarce, which indicated that there might be a considerable number of cases that went unrecorded, due to neglection. Health workers and testosterone users might pay more attention to testosterone-induced MACEs.
| S-EPMC10370495 | biostudies-literature
Project description:Niraparib was approved for the treatment of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube and primary peritoneal cancer. The authors retrospectively investigated niraparib-related adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Four algorithms were employed to quantify the signals of niraparib associated AEs, using data from the FAERS between 2017 and 2021. MYSQL 8.0, Navicat Premium 15, Microsoft EXCEL 2019 and the GraphPad Prism 8 were used to conduct statistical analysis. There are 7,238,157 reports collected from the FAERS database, of which 11,701 reports listed niraparib as the 'primary suspected (PS)' drug. A total of 97 significant disproportionality PTs conforming to the four algorithms were simultaneously retained. Unexpected significant AEs such as neuropathy peripheral, photosensitivity reaction, gastrooesophageal reflux disease might also occur. The median onset time of niraparib-associated AEs was 18 days (interquartile range [IQR] 4-66 days), and most of the cases occurred within the first months after niraparib initiation. The study found niraparib-associated AEs and might provide important support for clinical monitoring and risk identification of niraparib.
| S-EPMC9709073 | biostudies-literature
Project description:Background Venetoclax (VEN) is the first selective small molecule Bcl-2 inhibitor approved by FDA and used in adult chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and some acute myeloid leukemia (AML). However, the long-term safety of VEN in large sample population was unknown. This study evaluated the adverse events (AEs) of VEN from FDA Adverse Event Reporting System (FAERS) since its approval in 2016 by data mining. Methods The disproportionality analyses, including four algorithms of reporting odd ratio (ROR), proportional reporting ratio (PRR), bayesian configuration promotion neural network (BCPNN), and multi item gamma poisson shrinker (MGPS), were employed to quantify the signals of VEN-associated AEs. Results From the FAERS database, a total of 8,379,682 reports were collected during the study period. After removing the duplication, the number of reports with VEN as the primary suspect (PS) was 19,107. The 19,107 cases of AEs involved 27 organ systems, 256 significant PTs which conforming to the four algorithms. Unexpected serious AEs, such as pleural effusion, splenic infarction, atrial fibrillation, skin squamous cell carcinoma, etc., have signals. The median time of occurrence of AEs related to VEN was 31 days (inter quartile range [IQR] 7–131 days), and half of the reported AEs occurred within 1 month after administration. Conclusion Our research has found new significant AEs signals of VEN, which improved its safety information in real-world after marketing approval, and contributed to its risk control of use in clinic.
| S-EPMC9728853 | biostudies-literature