scholarly journals SAFETY PROFILE OF MIRTAZAPINE: A REAL-WORLD DISPROPORTIONALITY

2021 ◽  
Vol 10 (2) ◽  
pp. 20-24
Author(s):  
Chenthamarai.G ◽  
Lakshmi Prasanna.T.
Keyword(s):  
Adverse Events ◽  
Reporting System ◽  
Proportional Reporting Ratio ◽  
Antidepressant Drug ◽  
Severe Depression ◽  
Epidemiological Studies ◽  
Reporting Odds Ratio ◽  
Disproportionality Analysis ◽  
Post Marketing Surveillance ◽  
Safety Signals

Introduction: Mirtazapine is an antidepressant drug that produces both noradrenergic and serotonergic activity. It is effective in treating of mild to severe depression. Proper evidence pointing to the safety of Mirtazapine is not established. The need for post-marketing surveillance (PMS) is considered most essential. This study was aimed to generate signal for unreported adverse drug reactions for Mirtazapine.  Materials and Methods: Our study retrospectively analyzed the AEs reported entered in the Adverse Events Reporting System (FAERS) databases in the last 10-years during the period of Jan 2011 to June 2020. Disproportionality analysis was done using Reporting Odds Ratio, Proportional Reporting Ratio, and Information Component with 95% confidence interval. Results: A disproportionality analysis was done for 41 adverse events, out of these, signal for 11 adverse events was found. ROR values 10.17 being the highest for abulia and 2.22 being the lowest for homicidal Ideation. The PRR value was 10.17 being the highest for abulia and 2.22 being the lowest for homicidal ideation. The IC025 value was 1.87 for abulia and 0.27 for homicidal Ideation. Conclusion: The present study using the Adverse Events Reporting System (FAERS) databases maintained by the FDA suggested new safety signals for Mirtazapine. Still more cohort and epidemiological studies are recommended to validate these results. Keywords: Mirtazapine, Disproportionality analysis, Safety Signals.

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

Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

2019 ◽  
Vol 14 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Viswam Subeesh ◽  
Eswaran Maheswari ◽  
Hemendra Singh ◽  
Thomas Elsa Beulah ◽  
Ann Mary Swaroop
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Disproportionality Analysis ◽  
Positive Signal ◽  
Data Mining Algorithms ◽  
Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

scholarly journals Systematic analysis of safety profile for darunavir and its boosted agents using data mining in the FDA Adverse Event Reporting System database

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xiaojiang Tian ◽  
Yao Yao ◽  
Guanglin He ◽  
Yuntao Jia ◽  
Kejing Wang ◽  
...  
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Reporting System ◽  
Proportional Reporting Ratio ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Reporting Odds Ratio ◽  
Systematic Analysis ◽  
Event Reporting ◽  
Exfoliative Dermatitis

AbstractThis current investigation was aimed to generate signals for adverse events (AEs) of darunavir-containing agents by data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS). All AE reports for darunavir, darunavir/ritonavir, or darunavir/cobicistat between July 2006 and December 2019 were identified. The reporting Odds Ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) were used to detect the risk signals. A suspicious signal was generated only if the results of the three algorithms were all positive. A total of 10,756 reports were identified commonly observed in hepatobiliary, endocrine, cardiovascular, musculoskeletal, gastrointestinal, metabolic, and nutrition system. 40 suspicious signals were generated, and therein 20 signals were not included in the label. Severe high signals (i.e. progressive extraocular muscle paralysis, acute pancreatitis, exfoliative dermatitis, acquired lipodystrophy and mitochondrial toxicity) were identified. In pregnant women, umbilical cord abnormality, fetal growth restriction, low birth weight, stillbirth, premature rupture of membranes, premature birth and spontaneous abortion showed positive signals. Darunavir and its boosted agents induced AEs in various organs/tissues, and were shown to be possibly associated with multiple adverse pregnant conditions. This study highlighted some novel and severe AEs of darunavir which need to be monitored prospectively.

Drug-induced neuropsychiatric adverse events using post-marketing surveillance

2021 ◽  
Vol 16 ◽  
Author(s):  
Tomohito Wakabayashi ◽  
Takahiro Nakatsuji ◽  
Hiroko Kambara ◽  
Iku Niinomi ◽  
Saki Oyama ◽  
...  
Keyword(s):  
Spontaneous Reporting ◽  
Abnormal Behavior ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Neuraminidase Inhibitors ◽  
Disproportionality Analysis ◽  
Drug Induced ◽  
Real World Setting ◽  
Post Marketing Surveillance ◽  
Post Marketing

Background: Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs including neuraminidase inhibitors (NIs). However, information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify drugs associated with abnormal behavior using a spontaneous reporting system database. Methods: We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed. Drug associated with abnormal behavior were estimated using disproportionality analysis with calculation of the reporting odds ratio and 95% confidence interval. Results: A total of 1,144 reports of abnormal behavior were identified. Signals were detected showing the association of 4 including neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) with abnormal behavior, and these signals were stronger for oseltamivir than other neuraminidase inhibitors. Signals were also detected for acetaminophen and montelukast. Conclusion: Our results should raise physicians’ awareness of drugs associated with abnormal behavior, but further investigation of these medications is warranted.

scholarly journals Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 243 ◽  
Author(s):  
Jacob Puliyel ◽  
Pathik Naik
Keyword(s):  
Heart Disease ◽  
Adverse Events ◽  
Vaccine Safety ◽  
World Health Organisation ◽  
Epidemiological Studies ◽  
World Health ◽  
Causal Association ◽  
Risk Of Death ◽  
Post Marketing Surveillance ◽  
Definition Of

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as “consistent with causal association with vaccine”, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines that caused deaths in the control-trials stage would not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is “no other factor intervening in the processes.” Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children and this has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.

scholarly journals Exploring a Safety Signal of Antipsychotic-Associated Pneumonia: A Pharmacovigilance-Pharmacodynamic Study

2020 ◽  
Author(s):  
Dainora Cepaityte ◽  
Spyridon Siafis ◽  
Toine Egberts ◽  
Stefan Leucht ◽  
Dimitrios Kouvelas ◽  
...  
Keyword(s):  
Receptor Occupancy ◽  
Underlying Mechanism ◽  
P Value ◽  
Reporting Odds Ratio ◽  
Safety Signal ◽  
Disproportionality Analysis ◽  
Muscarinic Drugs ◽  
The Relationship ◽  
Safety Signals

Abstract An association between antipsychotic drugs and pneumonia has been demonstrated in several studies; however, the risk for pneumonia caused by specific antipsychotics has not been extensively studied. The underlying mechanism is still unknown, and several receptor mechanisms have been proposed. Therefore, using a combined pharmacovigilance-pharmacodynamic approach, we aimed to investigate safety signals of US Food and Drug Administration (FDA)-approved antipsychotics for reporting pneumonia and the potential receptor mechanisms involved. A disproportionality analysis was performed to detect a signal for reporting “infective-pneumonia” and “pneumonia-aspiration” and antipsychotics using reports submitted between 2004 and 2019 to the FDA adverse events spontaneous reporting system (FAERS) database. Disproportionality was estimated using the crude and the adjusted reporting odds ratio (aROR) and its 95% confidence interval (CI) in a multivariable logistic regression. Linear regressions investigated the relationship between aROR and receptor occupancy, which was estimated using in vitro receptor-binding profiles. Safety signals for reporting infective-pneumonia were identified for clozapine (LL = 95% 3.4, n = 546 [aROR: 4.8]) as well as olanzapine (LL = 95% 1.5, n = 250 [aROR: 2.1]) compared with haloperidol, while aRORs were associated with higher occupancies of muscarinic receptors (beta = .125, P-value = .016), yet other anti-muscarinic drugs were not included as potential confounders. No safety signals for reporting pneumonia-aspiration were detected for individual antipsychotics. Multiple antipsychotic use was associated with both reporting infective-pneumonia (LL 95%: 1.1, n = 369 [aROR:1.2]) and pneumonia-aspiration (LL 95%: 1.7, n = 194 [aROR: 2.0]). Considering the limitations of disproportionality analysis, further pharmacovigilance data and clinical causality assessment are needed to validate this safety signal.

scholarly journals Drug-Associated Delirium Identified in The Food and Drug Administration Adverse Events Reporting System

2019 ◽  
pp. 1-7
Author(s):  
Adrian Wong ◽  
Angela Li ◽  
Kane Gill ◽  
Matthew P. Gray ◽  
Pamela L. Smithburger ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Reporting System ◽  
Case Reports ◽  
Food And Drug Administration ◽  
Public Knowledge ◽  
Future Studies ◽  
The Public ◽  
Post Marketing Surveillance ◽  
Post Marketing

Introduction: Drug toxicity and polypharmacy are major risk factors for delirium, especially in older adult patients with underlying comorbidities. However, numerous case reports have described drugs with a lower suspicion of being deliriogenic. The objective of this study was to identify deliriogenic drugs in the Food and Drug Administration Adverse Events Reporting System (FAERS) to broaden the public knowledge and understanding. Study Design: Retrospective pharmacovigilance evaluation. Methods: FAERS reports from 2004 through 2015 were reviewed for delirium-associated terms, which were utilized to identify drugs most frequently reported to cause delirium. Drugs were categorized as: 1) known to be deliriogenic; 2) potentially deliriogenic; or 3) new potential to be deliriogenic. The 100 most frequently reported drugs were analyzed in reporting odds ratios (ROR). Results: Of the known deliriogenic drugs (n=32), paroxetine (ROR 4.1, CI 4.0-4.3), olanzapine (ROR 3.3, CI 3.2-3.4), and clozapine (ROR 2.9, CI 2.8-3.0) were most reported. Of the potentially deliriogenic drugs (n=54), duloxetine (ROR 3.2, CI 3.1-3.3), varenicline (ROR 3.1, CI 3.0-3.2), and gabapentin (ROR 2.9, CI 2.7-3.0) were most reported. Three drugs were considered to have new potential to be deliriogenic: heparin (ROR 1.5, CI 1.4-1.6), metformin (ROR 1.3, CI 1.3-1.4), and dalfampridine (ROR 1.1, CI 1.1-1.2). Conclusion: The majority of drugs were considered potentially deliriogenic. FAERS can provide post-marketing surveillance data to guide future studies on potentially deliriogenic drugs to guide management of causal agents.

scholarly journals Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016

2018 ◽  
Vol 23 (17) ◽  
Author(s):  
Dirk Mentzer ◽  
Doris Oberle ◽  
Brigitte Keller-Stanislawski
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Subcutaneous Tissue ◽  
Neurological Diseases ◽  
Proportional Reporting Ratio ◽  
Individual Case ◽  
European Medicines Agency ◽  
System Organ Class ◽  
Post Marketing Surveillance ◽  
Post Marketing

Background and aim In January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine’s launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

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.

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