Adverse events of tissue plasminogen activators in acute myocardial infarction patients: a real-world and pharmacovigilance database analysis
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SUBMITTER: Liu F
PROVIDER: S-EPMC11342586 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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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:Omalizumab is a biologic agent used in the management of allergic conditions, including asthma and urticaria. Although the efficacy of omalizumab has been well established, its safety profile is primarily derived from clinical trials with limited sample sizes. To conduct a comprehensive evaluation of its safety in larger populations, this study conducted an extensive analysis of data sourced from the America Food and Drug Administration's Adverse Event Reporting System (FAERS), with the aim of elucidating adverse drug events associated with omalizumab in real-world settings. We extracted reports of adverse events associated with omalizumab from the FAERS database covering the period from the first quarter of 2004 to the second quarter of 2024. We assessed the significance of the association between omalizumab and adverse events using four distinct methods of disproportionality analysis. Furthermore, we analyzed adverse events across gender and age subgroups. We identified a total of 49,456 adverse event reports linked to omalizumab and pinpointed 357 adverse events related to omalizumab within 27 system organ classes. These adverse events encompassed several commonly reported reactions documented in the product labeling, including anaphylactic reactions (ROR: 17.28, 95%CI:16.62-17.96) and asthma (ROR:19.24, 95%CI:18.74-19.76), alongside unlisted reactions such as asthmatic crisis (ROR: 47.3, 95%CI: 43-52.03), lower respiratory tract congestion (ROR: 35.68, 95%CI: 30.42-41.84). Furthermore, the results of our analysis indicated that omalizumab-related adverse events displayed significant gender and age disparities. The median time to onset for all documented adverse events was approximately 145 days, with a substantial proportion occurring after one year of treatment. This study not only offers a significant reference for optimizing the utilization of omalizumab, enhancing its efficacy while minimizing potential side effects, but also facilitates the safe application and broader implementation of omalizumab in clinical practice.
| S-EPMC11889112 | biostudies-literature
Project description:Introduction: Linezolid is an oxazolidinone antibiotic that is active against drug-resistant Gram-positive bacteria and multidrug-resistant Mycobacterium tuberculosis. Real-world studies on the safety of linezolid in large populations are lacking. This study aimed to determine the adverse events associated with linezolid in real-world settings by analyzing data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods: We retrospectively extracted reports on adverse drug events (ADEs) from the FAERS database from the first quarter of 2004 to that of 2023. By using disproportionality analysis including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), along with the multi-item gamma Poisson shrinker (MGPS), we evaluated whether there was a significant association between linezolid and ADE. The time to onset of ADE was further analyzed in the general population and within each age, weight, reporting population, and weight subgroups. Results: A total of 11,176 reports of linezolid as the "primary suspected" drug and 263 significant adverse events of linezolid were identified, including some common adverse events such as thrombocytopenia (n = 1,139, ROR 21.98), anaemia (n = 704, ROR 7.39), and unexpected signals that were not listed on the drug label such as rhabdomyolysis (n = 90, ROR 4.33), and electrocardiogram QT prolonged (n = 73, ROR 4.07). Linezolid-induced adverse reactions involved 27 System Organ Class (SOC). Gender differences existed in ADE signals related to linezolid. The median onset time of all ADEs was 6 days, and most ADEs (n = 3,778) occurred within the first month of linezolid use but some may continue to occur even after a year of treatment (n = 46). Conclusion: This study reports the time to onset of adverse effects in detail at the levels of SOC and specific preferred term (PT). The results of our study provide valuable insights for optimizing the use of linezolid and reducing potential side effects, expected to facilitate the safe use of linezolid in clinical settings.
| S-EPMC10904462 | biostudies-literature
Project description:BackgroundGlucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely used due to their profound efficacy in glycemic control and weight management. Within real-world contexts, the manifestation of certain psychiatric adverse events (AEs) has been observed, which is potentially linked to the administration of GLP-1 RAs. The objective of this study was to undertake a comprehensive investigation and characterization of the psychiatric AEs associated with GLP-1 RAs.MethodsWe retrieved reports of AEs associated with treatment with GLP-1 RAs during the period from the first quarter (Q1) of 2004 to Q1 2023 from the FDA Adverse Event Reporting System (FAERS) database. Descriptive analysis was performed to examine the clinical characteristics and time to onset of the psychiatric AEs caused by GLP-1 RAs. Moreover, disproportionality analyses were performed using the reporting odds ratio (ROR) to identify GLP-1 RA-related psychiatric AEs.ResultsA total of 8,240 reports of psychiatric AEs were analyzed out of 181,238 AE reports with treatment with GLP-1 RAs. Among these cases, a higher percentage was represented by women compared to men (65.89% vs. 30.96%). The median age of these patients was 56 years, with an interquartile range (IQR) of 48-67 years, based on data available in 286 case reports. This study showed that the median time to onset of the overall GLP-1 RA-related AEs was 31 days (IQR = 7-145.4 days), which varied among GLP-1 RA regimens. Specifically, exenatide had a significantly longer onset time at 45 days (IQR = 11-213 days), with statistically significant differences from the onset times of the other five GLP-1 RAs (p< 0.0001). Moreover, eight categories of psychiatric AEs, namely, nervousness (ROR = 1.97, 95% CI = 1.85-2.11), stress (ROR = 1.28, 95% CI = 1.19-1.38), eating disorder (ROR = 1.57, 95% CI = 1.40-1.77), fear of injection (ROR = 1.96, 95% CI = 1.60-2.40), sleep disorder due to general medical condition-insomnia type (ROR = 2.01, 95% CI = 1.60-2.52), binge eating (ROR = 2.70, 95% CI = 1.75-4.16), fear of eating (ROR 3.35, 95% CI = 1.65-6.78), and self-induced vomiting (ROR = 3.77, 95% CI = 1.77-8.03), were defined as GLP-1 RA-related psychiatric AEs through disproportionality analysis.ConclusionOur findings demonstrate a significant association between GLP-1 RAs and the development of specific psychiatric AEs. Despite the observational nature of this pharmacovigilance study and the inherent limitations of the FAERS database, our preliminary findings in this work could provide a better basis for understanding the potential psychiatric AEs that may occur with GLP-1 RA treatment, assisting clinicians to focus on these AEs and provide early intervention for optimal risk management.
| S-EPMC10882716 | 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:Objective: To mine the adverse drug event (ADE) signals of upadacitinib based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to provide a reference for the safe clinical use of the drug. Methods: The ADE data for upadacitinib from Q1 2004 to Q1 2023 in the FAERS database were retrieved, and data mining was performed using the reporting odds ratio and proportional reporting ratio. Results: A total of 21,213 ADE reports for the primary suspect drug upadacitinib were obtained, involving 444 ADEs. Patients aged ≥60 years (21.48%) and female (70.11%) patients were at a higher risk of ADEs with upadacitinib. After data cleaning, 182 ADE signals from 19 system organ classes (SOCs) were obtained. Six of these SOCs that occurred more frequently and were not mentioned in the drug labeling information included renal and urinary system (1.09%), reproductive and breast diseases (1.14%), ear and labyrinth disorders (0.57%), psychiatric disease (0.57%), blood and lymphatic system disorders (0.57%), and endocrine disorders (0.57%). The top ten most frequent ADE signals reported for upadacitinib were mainly related to: infections and infestations (7), investigations (2), and skin and subcutaneous tissue disorders (1). The top 10 ADEs in signal intensity ranking were lip neoplasm, ureteral neoplasm, eczema herpeticum, vulvar dysplasia, mediastinum neoplasm, eosinopenia, herpes zoster cutaneous disseminated, eye ulcer, acne cystic, and Moraxella infection. The top 10 high-frequency events leading to serious adverse events were urinary tract infection (2.74%), herpes zoster (1.63%), diverticulitis (1.19%), bronchitis (0.68%), nasopharyngitis (0.68%), localised infection (0.66%), nephrolithiasis (0.66%), pulmonary thrombosis (0.66%), blood cholesterol increased (0.55%), and Pneumocystis jirovecii pneumonia (0.53%). Conclusion: Clinicians should be vigilant to upadacitinib-induced events in systems not covered in the drug labeling information and to new and highly signaled ADEs to ensure the safe and effective use of upadacitinib.
| S-EPMC10469920 | biostudies-literature
Project description: Not available
| S-EPMC10847318 | biostudies-literature
Project description:ObjectiveLimited understanding exists regarding the haemorrhagic risk resulting from potential interactions between lenvatinib and pembrolizumab. We investigated haemorrhagic adverse events (ADEs) associated with co-administration of lenvatinib and pembrolizumab using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) in an effort to provide recommendations for their safe and sensible use.MethodsThe FAERS database's bleeding events linked to lenvatinib and pembrolizumab were carefully examined. Haemorrhagic signals mining was performed by the reported odds ratios (RORs) and information component (IC), corroborated by additive and multiplicative models.ResultsA total of 38,416,055 adverse event cases were analyzed, with 1188 bleeding events records in the lenvatinib alone, 952 bleeding events records in the pembrolizumab alone and 420 bleeding events reports in the combination therapy, respectively. We observed a significantly higher risk of haemorrhage with the combination of lenvatinib and pembrolizumab compare with pembrolizumab alone. In addition, in the baseline model analysis of suspected bleeding adverse reactions, the additive model detected an increased incidence of small intestinal haemorrhage caused by combination therapy, and found no risk signals of tumour haemorrhage and tracheal haemorrhage; the results of multiplicative model are all negative.ConclusionThe analysis of FAERS data reveals different levels of haemorrhagic risk when lenvatinib and pembrolizumab are administered concurrently, highlighting the significance of being cautious when using them in clinical practice.
| S-EPMC11863795 | biostudies-literature