Disproportionality analysis for signal detection of implantable cardioverter-defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System

2011 ◽  
Vol 21 (1) ◽  
pp. 87-93 ◽  
Author(s):  
Hesha J. Duggirala ◽  
Naomi D. Herz ◽  
Daniel Arthur Caños ◽  
Roberta A. Sullivan ◽  
Richard Schaaf ◽  
...  
Keyword(s):  
Adverse Events ◽  
Signal Detection ◽  
Implantable Cardioverter Defibrillator ◽  
Medical Device ◽  
Drug Administration ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Disproportionality Analysis ◽  
Administration Medical ◽  
Cardioverter Defibrillator

An analysis of food and drug administration medical device reports relating to total joint components

1997 ◽  
Vol 12 (7) ◽  
pp. 765-771 ◽  
Author(s):  
Frank P. Castro ◽  
George Chimento ◽  
Barry G. Munn ◽  
Richard S. Levy ◽  
Stephen Timon ◽  
...  
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Administration Medical

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.

Mortality and adverse events with brand and generic clopidogrel in the US Food and Drug Administration Adverse Event Reporting System

2018 ◽  
Vol 5 (4) ◽  
pp. 210-215 ◽  
Author(s):  
Victor L Serebruany ◽  
Trygve S Hall ◽  
Dan Atar ◽  
Stefan Agewall ◽  
Moo Hyun Kim ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Drug Administration ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Chi Square ◽  
Event Reporting ◽  
The Us

Abstract Aims Clopidogrel is commonly used even after expiring patents. The brand clopidogrel (BC) was dealt by single company, while numerous manufacturers produce generic clopidogrel (GC). There are no convincing data to compare the safety of different formulations. Therefore, the data yielded from international, uniform, government-mandated registries may be useful. Methods and results We assessed primary causative adverse events (PCAE) after BC and GC in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). The outcomes were divided into death, cardiac, thrombotic/embolic, haemorrhagic, and rash/dermal complications. These primary endpoints were then examined by proportional reporting ratios (PRR) and chi-square (χ2). Among total FAERS (n = 9 466 679) reports, overall BC (n = 88 863) cases were more common than after GC (n = 36 559). When triaged by PCAE role, BC (n = 18 328) was also more abundant than GC (n = 3987). The reported death rates were more than doubled after BC [18.4% vs. 7.0%; PRR = 0.38; 95% confidence interval (95% CI) 0.32–0.43; χ2=369.7; P<0.0001] for total FAERS, and consistent for late 2010–2017 (17.6% vs. 7.0% PRR = 0.40; 95% CI 0.37–0.45; χ2=286.2; P<0.004) PCAE cases. In contrast, GC trended to co-report more cardiac (14.6% vs. 13.3%; PRR = 1.12; 95% CI 1.0–1.25; χ2=3.5; P<0.06). The haemorrhagic (40.9% vs. 32.3%; PRR = 1.45; 95% CI 1.33–1.57; χ2=75.8; P<0.0001), and rash/dermal (5.4% vs. 4.6%; PRR = 1.20; 95% CI 1.0–1.44; χ2=3.75; P<0.05) events were also more common for GC. Thrombotic/embolic events were reported equally (at 7.0%) after each formulation. Conclusion The PCAE profiles differ with BC and GC in FAERS. While deaths reports were higher, the rates of cardiac, haemorrhagic, and skin complications were less common for BC. Despite expected reporting bias, this may indicate that the manufacturers of GC are reluctant to report deaths to the FDA. However, the overall adverse event profile suggests potentially better safety of BC over GC formulations.

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