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

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

Scientific Reports ◽

10.1038/s41598-021-91549-w ◽

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.

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Reporting Vaccine Complications: What Do Obstetricians and Gynecologists Know About the Vaccine Adverse Event Reporting System?

Infectious Diseases in Obstetrics and Gynecology ◽

10.1155/2013/285257 ◽

2013 ◽

Vol 2013 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

L. O. Eckert ◽

B. L. Anderson ◽

B. Gonik ◽

J. Schulkin

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Preventive Health Care ◽

Adverse Event Reporting ◽

Categorical Variables ◽

Event Reporting ◽

Chi Squared ◽

Question Survey

Background. Obstetrician-gynecologists are increasingly called upon to be vaccinators as an essential part of a woman’s primary and preventive health care. Despite the established safety of vaccines, vaccine adverse events may occur. A national Vaccine Adverse Event Reporting System (VAERS) is a well-established mechanism to track adverse events. However, we hypothesized that many obstetrician-gynecologists are naive to the role and use of VAERS.Methods. We devised a ten-question survey to a sample of ACOG fellows to assess their knowledge and understanding of VAERS. We performed descriptive and frequency analysis for each of the questions and used one-way analysis of variance for continuous and chi-squared for categorical variables.Results. Of the 1000 fellows who received the survey, 377 responded. Only one respondent answered all nine knowledge questions correctly, and 9.2% of physicians had used VAERS. Older physicians were less familiar with VAERS in general and with the specific objectives of VAERS in particular (χ2=10.7,P=.005).Conclusions. Obstetrician-gynecologist familiarity with VAERS is lacking. Only when the obstetrician-gynecologist is completely knowledgeable regarding standard vaccine practices, including the availability and use of programs such as VAERS, will providers be functioning as competent and complete vaccinators.

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I41 Post-marketing adverse events (AES) associated with tetrabenazine (TBZ): findings using FDA’s adverse event reporting system (FAERS)

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2016-314597.206 ◽

2016 ◽

Vol 87 (Suppl 1) ◽

pp. A73.2-A73

Author(s):

Daniel O Claassen ◽

Ravi Iyer ◽

Mo Dimbil ◽

Abril Giron ◽

Lisa De Boer ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Event Reporting ◽

Post Marketing

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Real-world Safety Profile of Darunavir and its Boosted Agents: An Analysis of FDA Adverse Event Reporting System Database

10.21203/rs.3.rs-225287/v1 ◽

2021 ◽

Author(s):

Xiaojiang Tian ◽

Yao Yao ◽

Guanglin He ◽

Yuntao Jia ◽

Kejing Wang ◽

...

Keyword(s):

Adverse Event ◽

Adverse Drug Events ◽

Reporting System ◽

Proportional Reporting Ratio ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Reporting Odds Ratio ◽

Event Reporting ◽

Exfoliative Dermatitis ◽

Adverse Pregnancy

Abstract This current investigation was aimed to generate signals for adverse drug events of darunavir-containing agents by data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS). All adverse event (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), 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 10756 AE reports were identified commonly observed in cardiovascular, endocrine, musculoskeletal, gastrointestinal, hepatobiliary, 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 associated with multiple adverse pregnancy conditions. This study highlighted some novel and severe AEs of darunavir which need to be monitored prospectively.

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Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

Psychotherapy and Psychosomatics ◽

10.1159/000510703 ◽

2020 ◽

Vol 90 (1) ◽

pp. 41-48

Author(s):

Chiara Gastaldon ◽

Emanuel Raschi ◽

John M. Kane ◽

Corrado Barbui ◽

Georgios Schoretsanitis

Keyword(s):

Adverse Event ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Mood Stabilizers ◽

Reporting Odds Ratio ◽

Event Reporting ◽

Completed Suicide ◽

Spontaneous Reports ◽

Post Marketing

Introduction: Esketamine nasal spray received approval for treatment-resistant depression in March 2019. Objective: Using the FDA Adverse Event Reporting System (FAERS) database (March 2019–March 2020), we analysed esketamine-related adverse events (AEs) to detect and characterize relevant safety signals. Methods: We used the consolidated case/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for esketamine-related AEs with ≥4 counts. Comparisons between serious and non-serious AEs were performed using non-parametric tests. Results: The FAERS database contained 962 cases of esketamine-related AEs, with signals detected for several AEs, such as dissociation (ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; IC = 8.19, 95% CI = 7.96, 8.35), sedation (ROR = 238.46, 95% CI = 202.98, 280.15; IC = 7, 95% CI = 6.75, 7.18), feeling drunk (ROR = 96.17, 95% CI = 61.42, 150.57; IC = 4.84, 95% CI = 4.09, 5.36), suicidal ideation (ROR = 24.03, 95% CI = 18.72, 30.84; IC = 4.31, 95% CI = 3.9, 4.61), and completed suicide (ROR = 5.75, 95% CI = 3.18, 10.41; IC = 2.25, 95% CI = 1.23, 2.94). Signals for suicidal and self-injurious ideation, but not suicide attempt and completed suicide, remained when comparing esketamine to venlafaxine. Females and patients receiving antidepressant polypharmacy, co-medication with mood stabilizers, antipsychotics, benzodiazepines, or somatic medications were more likely to suffer from serious versus non-serious AEs (χ2 = 125.29, p < 0.001, χ2 = 9.08, p = 0.003, χ2 = 8.14, p = 0.004, χ2 = 19.48, p < 0.001, χ2 = 25.62, p < 0.001, and χ2 = 16.79, p < 0.001, respectively). Conclusions: Esketamine may carry a clear potential for serious AEs, which deserves urgent clarification by means of further prospective studies.

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

10.2196/preprints.33311 ◽

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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Assessment of the Potential Adverse Events Related to Ribavirin-Interferon Combination for Novel Coronavirus Therapy

Computational and Mathematical Methods in Medicine ◽

10.1155/2020/1391583 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Wenya Shan ◽

Dongsheng Hong ◽

Jieqiang Zhu ◽

Qingwei Zhao

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Drug Event ◽

Reporting Odds Ratio ◽

Serious Adverse Events ◽

Bayesian Confidence Interval ◽

Novel Coronavirus ◽

Safety Signals

Purpose. We aimed to analyze and evaluate the safety signals of ribavirin-interferon combination through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS), so as to provide reference for the rationale use of these agents in the management of relevant toxicities emerging in patients with novel coronavirus pneumonia (COVID-19). Methods. Reports to the FAERS from 1 January 2004 to 8 March 2020 were analyzed. The proportion of report ratio (PRR), reporting odds ratio (ROR), and Bayesian confidence interval progressive neural network (BCPNN) method were used to detect the safety signals. Results. A total of 55 safety signals were detected from the top 250 adverse event reactions in 2200 reports, but 19 signals were not included in the drug labels. All the detected adverse event reactions were associated with 13 System Organ Classes (SOC), such as gastrointestinal, blood and lymph, hepatobiliary, endocrine, and various nervous systems. The most frequent adverse events were analyzed, and the results showed that females were more likely to suffer from anemia, vomiting, neutropenia, diarrhea, and insomnia. Conclusion. The ADE (adverse drug event) signal detection based on FAERS is helpful to clarify the potential adverse events related to ribavirin-interferon combination for novel coronavirus therapy; clinicians should pay attention to the adverse reactions of gastrointestinal and blood systems, closely monitor the fluctuations of the platelet count, and carry out necessary mental health interventions to avoid serious adverse events.

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Adverse outcomes associated with the treatment of Toxoplasma infections

Scientific Reports ◽

10.1038/s41598-020-80569-7 ◽

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.

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

Current Drug Safety ◽

10.2174/1574886313666181026100000 ◽

2019 ◽

Vol 14 (1) ◽

pp. 21-26 ◽

Cited By ~ 2

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.

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