scholarly journals From big data to bedside decision-making: the case for AdverseEvents

2013 ◽  
Vol 3 (1) ◽  
pp. 3
Author(s):  
Giuseppe Biondi Zoccai ◽  
Elena Cavarretta ◽  
Giacomo Frati
Keyword(s):  
Decision Making ◽  
Clinical Evidence ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Ease Of Use ◽  
Antithrombotic Agent ◽  
Post Marketing ◽  
The Individual ◽  
User Friendly ◽  
Based Medicine

<p>Evidence-based medicine has gained mainstream popularity, but it requires a delicate balance between clinical evidence, physician skills, patient preferences, and costs. Facing the individual patient, even a simple decision such as which antithrombotic agent should be prescribed becomes complex. There are several reasons for this conundrum, but one of the foremost is the limited external validity of pivotal randomized trials, with their extremely restrictive selection criteria. Post-marketing reporting of adverse events is a very useful and democratic means to appraise the risk-benefit profile, but to date such reports were not organized or available. The development of the Food and Drug Administration (FDA) venue for such task, the FDA Adverse Event Reporting System (FAERS) has substantially improved data collection. However, analysis of this extensive relational database remains complex for most but few companies or agencies. AdverseEvents is a novel online platform enabling updated and user-friendly inquiry of FAERS. Given its ease of use, flexibility and comprehensiveness, it is likely going to improve decision making for healthcare authorities and practitioners, as well as patients. This is clearly testified by the precise and informative comparative analysis that can be performed with AdverseEvents on novel antithrombotic agents.</p>

scholarly journals Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

2013 ◽  
Vol 3 (1) ◽  
pp. 4 ◽  
Author(s):  
Keith B. Hoffman ◽  
Brian M. Overstreet ◽  
P. Murali Doraiswamy
Keyword(s):  
Big Data ◽  
Adverse Events ◽  
Drug Safety ◽  
Case Reports ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Classes ◽  
Post Marketing ◽  
Approved Drugs ◽  
User Friendly

Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs) across best-selling drug classes [sometimes many years after winning Food and Drug Administration (FDA) approval] underscores the limitations of current clinical trial processes and reinforces the need for careful post-approval pharmacovigilance. The FDA’s sizeable repository of patient case reports linking AEs to approved drugs is the Adverse Event Reporting System (FAERS). We believe that open and user-friendly access to the millions of case reports in FAERS would help advance the field of post-marketing pharmacovigilance. However, FAERS data are virtually inaccessible to most physicians, pharmacists, and consumers. Accordingly, we have recently launched a big data platform (www.AdverseEvents.com) that, unlike previous efforts, provides on-demand, user-friendly, and high-impact access to FAERS data. Bringing the power of big data to regular users, such as clinicians, pharmacists, and patients, is the logical next step in the transformation of health care to a model of shared decision making between consumers and the system.

MetaADEDB 2.0: a comprehensive database on adverse drug events

2020 ◽  
Author(s):  
Zhuohang Yu ◽  
Zengrui Wu ◽  
Weihua Li ◽  
Guixia Liu ◽  
Yun Tang
Keyword(s):  
Safety Assessment ◽  
Adverse Drug Events ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Supplementary Information ◽  
Online Database ◽  
Web Interface ◽  
Drug Discovery And Development ◽  
Comprehensive Information ◽  
User Friendly

Abstract Summary MetaADEDB is an online database we developed to integrate comprehensive information on adverse drug events (ADEs). The first version of MetaADEDB was released in 2013 and has been widely used by researchers. However, it has not been updated for more than seven years. Here, we reported its second version by collecting more and newer data from the U.S. FDA Adverse Event Reporting System (FAERS) and Canada Vigilance Adverse Reaction Online Database, in addition to the original three sources. The new version consists of 744 709 drug–ADE associations between 8498 drugs and 13 193 ADEs, which has an over 40% increase in drug–ADE associations compared to the previous version. Meanwhile, we developed a new and user-friendly web interface for data search and analysis. We hope that MetaADEDB 2.0 could provide a useful tool for drug safety assessment and related studies in drug discovery and development. Availability and implementation The database is freely available at: http://lmmd.ecust.edu.cn/metaadedb/. Supplementary information Supplementary data are available at Bioinformatics online.

scholarly journals Serotonin syndrome by drug interactions with linezolid: clues from pharmacovigilance-pharmacokinetic/pharmacodynamic analysis

2020 ◽  
Author(s):  
Milo Gatti ◽  
Emanuel Raschi ◽  
Fabrizio De Ponti
Keyword(s):  
Drug Interactions ◽  
Serotonin Syndrome ◽  
Adverse Event Reporting System ◽  
Integrated Approach ◽  
Volume Of Distribution ◽  
Adverse Event Reporting ◽  
Pharmacodynamic Analysis ◽  
Central Nervous System Penetration ◽  
Post Marketing ◽  
Serotonin Reuptake Transporter

Abstract Purpose To characterize the post-marketing reporting of serotonin syndrome (SS) due to drug-drug interactions (DDIs) with linezolid and investigate the relationship with pharmacokinetic/pharmacodynamic (PK/PD) properties of serotonergic agents. Methods We queried the worldwide FDA Adverse Event Reporting System to extract SS records due to DDIs where linezolid was reported as suspect. For each serotonergic agent concomitantly reported, proportion of SS reports and mean number of DDIs were calculated and three different “SS reporting zones” were created. Relevant PK (peak concentration, area under plasma concentration curve, volume of distribution (VD), and lipophilicity) and PD (values of binding affinity (Ki) and IC50 for serotonin reuptake transporter (SERT) and 5-HT2A) parameters were extracted for each serotonergic agent, and relevant PK/PD indexes were calculated to assess correlation with mean number of DDIs (PV index). Results Six hundred sixty-nine reports of SS mentioning linezolid were found, being linezolid-citalopram (N = 69; 10.3%) the most frequently DDI reported. Citalopram and methadone showed respectively the highest proportion of SS reports (0.28%) and the lowest mean number of DDIs (1.41). Citalopram, escitalopram, and methadone emerged as red (i.e., alert)-zone medications: they exhibited high lipophilicity and large VD (proxies of excellent central nervous system penetration) coupled with high potency. Among PK/PD indexes, a significant correlation with PV index was found for VD/Ki SERT ratio (p = 0.05). Discussion Our integrated approach suggests that linezolid is more likely to cause SS when co-administered with citalopram, escitalopram, and methadone, as inferred from their pharmacological properties. Proper management of SS should be tailored on a case-by-case basis.

Clinical Decision-Making for a Person Centered Medicine: the necessity of casuistic reasoning

2014 ◽  
Vol 2 (1) ◽  
pp. 71
Author(s):  
Mark Tonelli
Keyword(s):  
Decision Making ◽  
Clinical Judgment ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Patient Choice ◽  
Clinical Expertise ◽  
Patient Centered ◽  
Patient Centered Medicine ◽  
The Individual ◽  
Based Medicine

In their call to develop a consistent, coherent and comprehensive notion of person-centered medicine, Miles and Mezzich have elucidated several specific challenges that need to be urgently addressed. One of these foundational tasks is the development of a more complete understanding of person-centered clinical decision-making. Miles and Mezzich note that while the emphasis on clinical research in evidence-based medicine has served to de-emphasize the importance of the individual patient, the alternative of patient-centered medicine has the potential to de-emphasize the judgment of the clinician by making unfettered patient choice paramount. A practice of medicine that reduces professional healers to an informational role only, one where they lay out potential interventions devoid of context and allow patients to choose from amongst them, undervalues clinical expertise and will clearly not lead to better outcomes. Person-centered medicine (PCM), then, must be able to develop and defend a model of clinical judgment and practice that strikes the correct balance between the science of medicine and the personal experience of the individual in search of care.

scholarly journals Myocarditis occurrence with cancer immunotherapy across indications in clinical trial and post-marketing data

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Tigran Makunts ◽  
Ila M. Saunders ◽  
Isaac V. Cohen ◽  
Mengxing Li ◽  
Talar Moumedjian ◽  
...  
Keyword(s):  
Cancer Immunotherapy ◽  
Immune Checkpoint ◽  
Kinase Inhibitor ◽  
Checkpoint Inhibitors ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Post Marketing ◽  
Marketing Data ◽  
Cancer Types ◽  
Tumor Types

AbstractAntibodies targeting the PD-1, PD-L1, and CTLA-4 immune checkpoint axis have been used in a variety of tumor types. They achieve anti-tumor activity through activating the patient’s own immune system to target immune response evading cancer cells. However, this unique mechanism of action may cause immune-related adverse events, irAEs. One of these irAEs is myocarditis which is associated with an alarming mortality rate. In this study we presented clinical cases of myocarditis from safety trial datasets submitted to the U.S. Food and Drug Administration, FDA. Additionally, we analyzed over fourteen million FDA Adverse Event Reporting System, FAERS, submissions. The statistical analysis of the FAERS data provided evidence of significantly increased reporting of myocarditis in patients administered immune checkpoint inhibitors alone, in combination with another immune checkpoint inhibitor, the kinase inhibitor axitinib, or chemotherapy, for all cancer types, when compared to patients administered chemotherapy. All combination therapies led to further increased reporting odds ratios of myocarditis. We further analyzed the occurrence of myocarditis by stratifying the reports into sub-cohorts based on specific cancer types and treatment/control groups in major cancer immunotherapy efficacy trials and confirmed the observed trend for each cohort.

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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