Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration’s Adverse Event Reporting System, 2010-2017

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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Adverse Events Associated with Use of Digoxin Immune Fab Reported to the US Food and Drug Administration Adverse Event Reporting System, 1986–2019

Drugs - Real World Outcomes ◽

10.1007/s40801-021-00242-x ◽

2021 ◽

Author(s):

Shaokui Wei ◽

Manette T. Niu ◽

Graça M. Dores

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Drug Administration ◽

Reporting System ◽

Food And Drug Administration ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Event Reporting ◽

The Us

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Novel Adverse Events of Bevacizumab in the US FDA Adverse Event Reporting System Database

Drug Safety ◽

10.2165/11597600-000000000-00000 ◽

2012 ◽

Vol 35 (6) ◽

pp. 507-518 ◽

Cited By ~ 25

Author(s):

Behrooz K. Shamloo ◽

Pankdeep Chhabra ◽

Andrew N. Freedman ◽

Arnold Potosky ◽

Jennifer Malin ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Event Reporting ◽

System Database ◽

The Us ◽

Us Fda

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PCN259 SKELETAL ADVERSE EVENTS ASSOCIATED WITH IMMUNE CHECKPOINT INHIBITORS: EMERGING TRENDS FROM THE US FOOD AND DRUG ADMINISTRATION ADVERSE EVENT REPORTING SYSTEM

Value in Health ◽

10.1016/j.jval.2019.09.454 ◽

2019 ◽

Vol 22 ◽

pp. S486

Author(s):

X. Pundole ◽

M. Sarangdhar ◽

M.E. Suarez-Almazor

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Immune Checkpoint Inhibitors ◽

Reporting System ◽

Checkpoint Inhibitors ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Event Reporting ◽

Emerging Trends ◽

The Us

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Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System

Drug Safety ◽

10.1007/s40264-020-01022-2 ◽

2020 ◽

Author(s):

Henry Trumbo ◽

Karolina Kaluza ◽

Syed Numan ◽

Lawrence T. Goodnough

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Drug Administration ◽

Reporting System ◽

Adverse Event Reporting System ◽

Intravenous Iron ◽

Adverse Event Reporting ◽

Event Reporting ◽

The Us ◽

The Usa

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Comment on: Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System

Drug Safety ◽

10.1007/s40264-021-01058-y ◽

2021 ◽

Author(s):

Michael Auerbach

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Drug Administration ◽

Reporting System ◽

Adverse Event Reporting System ◽

Intravenous Iron ◽

Adverse Event Reporting ◽

Event Reporting ◽

The Us ◽

The Usa

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OP0197 Rheumatic and musculoskeletal adverse events associated with immune checkpoint inhibitors: data mining of the us food and drug administration adverse event reporting system

10.1136/annrheumdis-2018-eular.6113 ◽

2018 ◽

Cited By ~ 1

Author(s):

X. Pundole ◽

M. Sarangdhar ◽

M.E. Suarez-Almazor

Keyword(s):

Data Mining ◽

Adverse Event ◽

Adverse Events ◽

Immune Checkpoint Inhibitors ◽

Reporting System ◽

Checkpoint Inhibitors ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Event Reporting ◽

The Us

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Abstract 16041: Examining the Nocebo Effect of Statins Using Statin Adverse Events Reported in the FDA Adverse Event Reporting System

Circulation ◽

10.1161/circ.142.suppl_3.16041 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Jungyeon Moon ◽

Robert Cohen Sedgh ◽

Cynthia JACKEVICIUS

Keyword(s):

Nervous System ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Quantitative Detection ◽

Nocebo Effect ◽

Event Reporting ◽

The Us

Introduction: Comparison of blinded and nonblinded statin trials have confirmed a nocebo effect, most commonly presenting as subjective muscle and nervous system adverse events (AEs). This study evaluated whether the increase in reported statin AEs over time was associated with the nocebo effect by comparing nocebo-related subjective with objective AEs. Method: A retrospective cohort study was conducted using the FDA Adverse Event Reporting System (FAERS) of statin-associated AEs from 1/2010-12/2019. Statins selected for analysis were atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin. Subjective AEs included fatigue, subjective muscular, and nervous system AEs. Objective AEs were hepatic and objective muscular AEs. We compared the number of subjective and objective AEs using Mann-Whitney U, and evaluated the association between AEs and gender and country using linear regression. Quantitative detection of signals was estimated using reporting odds ratio (ROR). Institutional Review Board review was exempt since we used de-identified public data. Results: Of 2,994,487 statin AE reports, more subjective than objective AEs were reported per quarter (mean ± SD: 4777 ± 1375.45 vs 999 ± 276.95; p<0.0001). Simvastatin-associated reports showed signals for higher objective muscular AEs relative to all other statins (ROR 1.53, 95% CI: 1.49-1.58). Females reported more subjective AEs than males per quarter (fatigue 86.98, p=0.035; subjective muscular AE 417.95, p<0.0001; nervous system AE 273.60, p<0.0001), but fewer objective muscular AEs (-125.23, p<0.0001). More subjective AEs and fewer objective AEs were reported in the US relative to other countries per quarter (p<0.0001). Conclusion: This study found that significantly more subjective than objective AEs are reported for statins. Subjective statin AEs, potentially related to the nocebo effect are reported more often by females than by males, and in the US than in other countries.

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