scholarly journals Medication Associated Salivary Gland Alterations– Assessment of risk

2019 ◽  
pp. 26-33
Author(s):  
Rooban Thavarajah ◽  
Elizabeth Joshua ◽  
Umadevi Rao ◽  
Kannan Ranganathan
Keyword(s):  
Salivary Gland ◽  
Adverse Events ◽  
Odds Ratio ◽  
Adverse Event Reporting System ◽  
The United States ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Chronic Medication ◽  
Specific Description ◽  
Salivary Gland Enlargement

Brief Background Medication Associated Salivary Gland Alterations (MASGA) are a common set of adverse events (AE) associated with many common medications. There are a few reports of the risk of MASGA with medication. Materials and Methods Using whole database approach, the Food and Drug Administration Adverse Event Reporting System (FAERS) of the United States of America was searched for MASGA. Common alterations and drugs associated were assessed for the Reporting Odds Ratio, as mentioned in pharmacovigilance researches. Results In the time phase considered, there were in all 16996785 AE reported in the FAERs database. Of this 68624 were related to MASGA with Dry Mouth and hypersecretion being most common. Anti-psychotic drugs predominated the hypersecretion spectrum with clozapine having a ROR of 58.04 followed by Haloperidol (25.29). Among the drugs that caused SG enlargement, potassium iodide (1335.32) and Oxyphenbutazone (696.58) had the highest ROR. Non-specific description of altered saliva was seen with high ROR in haloperidol and enoxaparin sodium (14.22). Summary and Conclusions Odds Ratio of drugs causing MASGA are. chronic medication such as those given for non-communicable, life style diseases and psychiatric medications known to cause MASGA. Key Words Salivary Alterations, Xerostomia, Salivary gland enlargement, Adverse Events, Pharmacovigilance

scholarly journals Adverse outcomes associated with the treatment of Toxoplasma infections

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ahmed M. Shammaa ◽  
Thomas G. Powell ◽  
Imaan Benmerzouga
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Real World ◽  
Odds Ratio ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Adverse Outcomes ◽  
Reporting Odds Ratio ◽  
Real World Data ◽  
Suspect Drug

AbstractAdverse outcomes associated with the treatment of Toxoplasma gondii infections in patients with various health backgrounds have not been characterized. The aim of this study was to identify the adverse outcomes and adverse events associated with the current clinical treatments of Toxoplama gondii infections using real world data reported to the FDA adverse event reporting system (FAERS). Data submitted to FAERS between 2013 and 2019 was retrieved and analyzed. Reporting odds ratio of death was calculated for the drugs having ≥ 25 reports of adverse outcomes. The adverse event profiles for the same drugs were analyzed and the reporting odds ratio was calculated relative to all other drugs used in the treatment of Toxoplasma infections. There were 503 cases reporting the treatment of Toxoplasma infections in the FAERS database. Death (DE) was the adverse outcome in 102 reports, of which 23 (22.5%) anti-Toxoplasma drugs were listed as the primary suspect drug (PS). Clindamycin (2.04; 1.07–3.90) followed by pyrimethamine (1.53; 0.99–2.36) were the most likely to be associated with death. Adverse events analysis suggest that sulfonamides formulations may have a less favorable safety profile. Our study represents the first real-world analysis of adverse outcomes and events associated with the treatment of Toxoplasma infections. Our findings support the need to better understand the current first-line agents for Toxoplasma infections, in addition to underscoring the need to identify safer regimens.

scholarly journals Thrombocytopenia with Tedizolid and Linezolid

2017 ◽  
Vol 62 (1) ◽  
Author(s):  
Erica Yookyung Lee ◽  
Aisling R. Caffrey
Keyword(s):  
Adverse Event ◽  
Confidence Interval ◽  
Drug Administration ◽  
Odds Ratio ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Event Reporting ◽  
Using Data

ABSTRACT Several studies have suggested the risk of thrombocytopenia with tedizolid, a second-in-class oxazolidinone antibiotic (approved June 2014), is less than that observed with linezolid (first-in-class oxazolidinone). Using data from the Food and Drug Administration adverse event reporting system (July 2014 through December 2016), we observed significantly increased risks of thrombocytopenia of similar magnitudes with both antibiotics: linezolid reporting odds ratio [ROR], 37.9 (95% confidence interval [CI], 20.78 to 69.17); tedizolid ROR, 34.0 (95% CI, 4.67 to 247.30).

scholarly journals Common Immune-Related Adverse Events of Immune Checkpoint Inhibitors in the Gastrointestinal System: A Study Based on the US Food and Drug Administration Adverse Event Reporting System

2021 ◽  
Vol 12 ◽  
Author(s):  
Xiaoyin Bai ◽  
Shiyu Jiang ◽  
Yangzhong Zhou ◽  
Hongnan Zhen ◽  
Junyi Ji ◽  
...  
Keyword(s):  
Adverse Events ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Reporting System ◽  
Checkpoint Inhibitors ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Logistic Analysis ◽  
The Us

Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment; however, immune-related adverse events (irAEs) in the gastrointestinal (GI) system commonly occur. In this study, data were obtained from the US Food and Drug Administration adverse event reporting system between July 2014 and December 2020. Colitis, hepatobiliary disorders, and pancreatitis were identified as irAEs in our study. Reporting odds ratio (ROR) with information components (IC) was adopted for disproportionate analysis. A total of 70,330 adverse events were reported during the selected period, 4,075 records of which were associated with ICIs. GI toxicities have been reportedly increased with ICI, with ROR025 of 17.2, 6.7, and 2.3 for colitis, hepatobiliary disorders, and pancreatitis, respectively. The risks of colitis, hepatobiliary disorders, and pancreatitis were higher with anti-CTLA-4 treatment than that with anti-PD-1 (ROR025 2.6, 1.3, and 1.1, respectively) or anti-PD-L1 treatment (ROR025 4.8, 1.3, and 1.3, respectively). Logistic analysis indicated that hepatobiliary disorders and pancreatitis more frequently occurred in female patients (adjusted odds ratio, 1.16 and 1.52; both p < 0.05). Consistently, polytherapy was a strong risk factor for colitis (adjusted odds ratio 2.52, p < 0.001), hepatobiliary disorders (adjusted odds ratio 2.50, p < 0.001), and pancreatitis (adjusted odds ratio 2.29, p < 0.001) according to multivariate logistic analysis. This pharmacovigilance analysis demonstrated an increased risk of all three GI irAEs associated with ICI therapies. The comparative analysis offered supportive insights on selecting GI irAEs for patients treated with ICIs.

Neurodevelopmental Disorders Following Thimerosal-Containing Childhood Immunizations: A Follow-Up Analysis

2004 ◽  
Vol 23 (6) ◽  
pp. 369-376 ◽  
Author(s):  
David A. Geier ◽  
Mark R. Geier
Keyword(s):  
United States ◽  
Adverse Events ◽  
Neurodevelopmental Disorders ◽  
Adverse Event Reporting System ◽  
The United States ◽  
Adverse Event Reporting ◽  
Number Of Children ◽  
Childhood Immunizations ◽  
Potential Association ◽  
Childhood Vaccines

The authors previously published the first epidemiological study from the United States associating thimerosal from childhood vaccines with neurodevelopmental disorders (NDs) based upon assessment of the Vaccine Adverse Event Reporting System (VAERS). A number of years have gone by since their previous analysis of the VAERS. The present study was undertaken to determine whether the previously observed effect between thimerosal-containing childhood vaccines and NDs are still apparent in the VAERS as children have had a chance to further mature and potentially be diagnosed with additional NDs. In the present study, a cohort of children receiving thimerosal-containing diphtheria-tetanus-acellular pertussis (DTaP) vaccines in comparison to a cohort of children receiving thimerosal-free DTaP vaccines administered from 1997 through 2000 based upon an assessment of adverse events reported to the VAERS were evaluated. It was determined that there were significantly increased odds ratios (ORs) for autism (OR = 1.8, p < .05), mental retardation (OR = 2.6, p < .002), speech disorder (OR = 2.1, p <.02), personality disorders (OR=2.6, p <.01), and thinking abnormality (OR=8.2, p <.01) adverse events reported to the VAERS following thimerosal-containing DTaP vaccines in comparison to thimerosal-free DTaP vaccines. Potential confounders and reporting biases were found to be minimal in this assessment of the VAERS. It was observed, even though the media has reported a potential association between autism and thimerosal exposure, that the other NDs analyzed in this assessment of the VAERS had significantly higher ORs than autism following thimerosal-containing DTaP vaccines in comparison to thimerosal-free DTaP vaccines. The present study provides additional epidemiological evidence supporting previous epidemiological, clinical and experimental evidence that administration of thimerosal-containing vaccines in the United States resulted in a significant number of children developing NDs.

scholarly journals Risk of bronchospasm and coronary arteriospasm with sugammadex use: a post marketing analysis

2019 ◽  
Vol 10 ◽  
pp. 204209861986907 ◽  
Author(s):  
Pushkar Aggarwal
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Signal Analysis ◽  
Proportional Reporting Ratio ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Potential Association ◽  
Chi Squared ◽  
Post Marketing

Introduction: Sugammadex is used for the reversal of neuromuscular blockade caused by rocuronium bromide and vecuronium bromide. As part of the post licensing phase of drug development, adverse events related to the use of sugammadex are still being uncovered and being reported. The potential association between sugammadex and adverse events bronchospasm and coronary arteriospasm using a retrospective pharmacovigilance signal analysis was carried out. Methods: Food and Drug Administration’s Adverse Event Reporting System database was used to run disproportionality analyses to investigate the potential association of sugammadex with bronchospasm or coronary arteriospasm. In this analysis we report the adverse event signal using frequentist methods of Relative reporting ratio (RRR), proportional reporting ratio (PRR), reporting odds ratio (ROR) and the Bayesian based Information Component metric. Results: A statistically significant disproportionality signal is found between sugammadex and bronchospasm ( n = 44; chi-squared = 2993.87; PRR = 71.95 [95% CI: 54.00–95.85]) and sugammadex and coronary arteriospasm ( n = 6; chi-squared = 209.39; PRR = 43.82 [95% CI: 19.73–97.33]) as per Evans criteria. Both statistically significant disproportionality signals persisted when stratified by gender. Based upon dynamic cumulative PRR graph, the PRR value has steadily increased and the 95% CI narrowed since December 2012. Conclusion: The results of the pharmacovigilance analysis highlight a statistically significant disproportionality signal between sugammadex usage and bronchospasm and coronary arteriospasm adverse events. Physicians need to be aware of these adverse events when using sugammadex. The results of the pharmacovigilance signal analysis highlight a statistically significant disproportionality signal between sugammadex usage and bronchospasm and coronary arteriospasm adverse events. Physicians need to be aware of these adverse events when using sugammadex.

COVID Vaccine and Cardiovascular Signals: An Analysis of Vaccine Adverse Event Reports (Preprint)

2021 ◽  
Author(s):  
Yiqing Zhao ◽  
Michael Ison ◽  
Yuan Luo
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Odds Ratio ◽  
Spontaneous Reporting ◽  
Reporting System ◽  
Spontaneous Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
High Odds

UNSTRUCTURED Adverse events (AEs) following COVID vaccination have been intensely monitored. In our study, we analyzed data from a spontaneous reporting system - Vaccine Adverse Event Reporting System and detected signals of AEs following administration of COVID vaccines. We identified several cardiovascular and inflammatory-related AEs that demonstrated high odds ratio. We demonstrated our system can serve as a complementary system to identify and monitor AEs outside of pre-defined outcomes routinely monitored by existing databases or projects.

Triptans and serious adverse vascular events: Data mining of the FDA Adverse Event Reporting System database

Cephalalgia ◽  
2013 ◽  
Vol 34 (1) ◽  
pp. 5-13 ◽  
Author(s):  
Giuseppe Roberto ◽  
Carlo Piccinni ◽  
Roberto D’Alessandro ◽  
Elisabetta Poluzzi
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
The United States ◽  
Adverse Event Reporting ◽  
Special Focus ◽  
Vascular Events ◽  
Event Reporting ◽  
Vascular Insufficiency

Aim The aim of this article is to investigate the vascular safety profile of triptans through an analysis of the United States Food and Drug Administration Adverse Event Reporting System (FDA_AERS) database with a special focus on serious and unexpected adverse events. Methods A case/non-case analysis was performed on the reports entered in the FDA_AERS from 2004 to 2010: Cases were reports with at least one event included in the MedDRA system organ classes ‘Cardiac disorder’ or ‘Vascular disorders’, whereas non-cases were all the remaining reports. Co-reported cardiovascular drugs were used as a proxy of cardiovascular risk and the adjusted reporting odds ratio (adj.ROR) with 95% confidence intervals (95% CI) was calculated. Disproportionality signals were defined as adj.ROR value >1. Adverse events were considered unexpected if not mentioned on the relevant label. Results Among 2,131,688 reports, 7808 concerned triptans. Cases were 2593 among triptans and 665,940 for all other drugs. Unexpected disproportionality signals were found in the following high-level terms of the MedDRA hierarchy: ‘Cerebrovascular and spinal necrosis and vascular insufficiency’ (103 triptan cases), ‘Aneurysms and dissections non-site specific’ (15), ‘Pregnancy-associated hypertension’ (10), ‘Reproductive system necrosis and vascular insufficiency’ (3). Discussion Our analysis revealed three main groups of unexpected associations between triptans and serious vascular events: ischaemic cerebrovascular events, aneurysms and artery dissections, and pregnancy-related vascular events. A case-by-case assessment is needed to confirm or disprove their plausibility and large-scale analytical studies should be planned for risk rate estimation. In the meantime, clinicians should pay special attention to migraine diagnosis and vascular risk assessment before prescribing a triptan, also promptly reporting any unexpected event to pharmacovigilance systems.

Comparison of Online Patient’s Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study (Preprint)

2021 ◽  
Author(s):  
Susan Park ◽  
So-Hyun Choi ◽  
Yun-Kyung Song ◽  
Jin-Won Kwon
Keyword(s):  
Social Media ◽  
Adverse Events ◽  
Signal Detection ◽  
Proportional Reporting Ratio ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Media Analysis ◽  
Reporting Odds Ratio ◽  
Disproportionality Analysis ◽  
Drug Label

BACKGROUND Tramadol is known to cause fewer adverse events (AE) than other opioids. However, recent research has raised concerns about various safety issues. OBJECTIVE We aimed to explore these new AE related to tramadol using social media and conventional pharmacovigilance data. METHODS This study used two datasets, one from patients’ drug reviews on WebMD and one from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). We analyzed 2,062 and 29,350 patient reports from WebMD and FAERS, respectively. Patient posts on WebMD were manually assigned the preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA). To analyze AE from FAERS, a disproportionality analysis was performed with three measures: the proportional reporting ratio (PRR), the reporting odds ratio (ROR), and the information component (IC). RESULTS From the 869 AE reported, we identified 125 new signals related to tramadol use not listed on the drug label that satisfied all three signal detection criteria. In addition, 20 serious AE were selected from new signals. Among new serious AEs, vascular disorders had the largest signal detection criteria value. Based on the disproportionality analysis and patients’ symptom descriptions, tramadol-induced pain might also be an unexpected AE. CONCLUSIONS This study detected several novel signals related to tramadol use, suggesting newly identified possible AE. Additionally, this study indicates that unexpected AEs can be detected using social media analysis alongside traditional pharmacovigilance data. CLINICALTRIAL N/A

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