Neurological events with tumour necrosis factor alpha inhibitors reported to the Food and Drug Administration Adverse Event Reporting System

Deepak, Parakkal; Stobaugh, Derrick J.; Sherid, Muhammed; Sifuentes, Humberto; Ehrenpreis, Eli D.

doi:10.1111/apt.12385

Cited by 75 publications

(67 citation statements)

References 34 publications

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“…Despite these reports, the Food and Drug Administration Adverse Event Reporting System has not found a statistically increased risk of cerebrovascular disease in patients taking anti-TNF-a therapy. 13 Potential mechanisms of arterial ischemic stroke in our patient include arterial thromboembolic disease, local endothelial activation, and vasculitis. 6 Although risk of thromboembolic disease is elevated in IBD, arterial thromboembolic disease in IBD tends to occur in individuals with severe pancolitis who are at high risk for luminal intestinal loss of serum proteins or in patients with recent surgery.…”

Section: Discussionmentioning

confidence: 87%

Fatal Central Nervous System Disease Following First Infliximab Infusion in a Child With Inflammatory Bowel Disease

Bäumer

Ouahed

Verhave

et al. 2016

Pediatric Neurology

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Section: Discussionmentioning

confidence: 87%

Fatal Central Nervous System Disease Following First Infliximab Infusion in a Child With Inflammatory Bowel Disease

Bäumer

Ouahed

Verhave

et al. 2016

Pediatric Neurology

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“…It has been previously validated, with high within-rater and inter-rater retest reliability in addition to consensual, content and concurrent validity [18]. This has been used previously by our group to analyze the association between exposure to TNF-α inhibitors and the development of neurological adverse events [19]. For questions with possible ambiguity; a priori were developed to prevent subjectivity.…”

Section: Methodsmentioning

confidence: 99%

Assessing the likelihood of new-onset inflammatory bowel disease following tumor necrosis factor-alpha inhibitor therapy for rheumatoid arthritis and juvenile rheumatoid arthritis

2014

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The association between inhibition of tumor necrosis factor-alpha (TNF-α) in patients with rheumatoid arthritis (RA) and juvenile rheumatoid arthritis (JRA) and the onset of inflammatory bowel disease (IBD) is unclear. We sought to evaluate this association by analyzing adverse events (AEs) reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) with a standardized scoring tool for drug-induced AEs. A search of the FAERS for RA or JRA (January 2003-December 2011) reported with adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab was performed. This dataset was then queried for cases indicating IBD. Full-length reports were accessed using the Freedom of Information Act and organized by age, sex, concomitant medications, co-morbidities, type of TNF-α inhibitor used, and diagnosis/treatment details. The Naranjo score was used to determine whether the drug-induced AEs were definite, probable, possible, or doubtful. There were 158 cases of IBD after TNF-α inhibitor exposure in RA or JRA patients. Use of the Naranjo score revealed that, in a majority of the cases (71.5 %), TNF-α inhibitor exposure was considered a 'possible' cause. A majority of the 'probable cases' in JRA were reported with etanercept (40 patients, 90.91 %). There were no 'definite' cases of anti-TNF-induced IBD. After applying the Naranjo scale, a weak association between new-onset IBD and TNF-α inhibitor therapy in RA patients and a moderately strong association especially with etanercept exposure in JRA patients was observed. However, causality cannot be determined due to limitations of the FAERS and the Naranjo score.

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“…malabsorption-related vitamin deicit) and adverse efects of IBD therapeutic agents (e.g. metronidazole or anti-TNF agents) [48][49][50]. Whenever these causes are ruled out, the frequency of PN in IBD patients varies from 0 to 39% [51].…”

Section: Peripheral Neuropathymentioning

confidence: 99%

Neurological Manifestations of Inflammatory Bowel Disease

Plata‐Bello¹,

Acosta-López²

2018

New Concepts in Inflammatory Bowel Disease

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The inlammatory bowel disease (IBD) is associated with diferent neurological and psychiatric disorders, which are integrated among the extra-intestinal manifestation of this disease. The physiopathology of neurological manifestations of IBD varies among the diferent kind of complications. The origin and the signiicance of these manifestations must be understood by clinicians who manage IBD patients. Some of them are related to therapeutic agents. The present chapter consists of a review of the most prevalent neurological and psychiatric disorders associated with IBD. The physiopathology of those entities will also be discussed, as well as the appropriate management for their prevention and treatment.

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Neurological events with tumour necrosis factor alpha inhibitors reported to the Food and Drug Administration Adverse Event Reporting System

Abstract: SUMMARY Background

Cited by 75 publications

References 34 publications

Fatal Central Nervous System Disease Following First Infliximab Infusion in a Child With Inflammatory Bowel Disease

Fatal Central Nervous System Disease Following First Infliximab Infusion in a Child With Inflammatory Bowel Disease

Assessing the likelihood of new-onset inflammatory bowel disease following tumor necrosis factor-alpha inhibitor therapy for rheumatoid arthritis and juvenile rheumatoid arthritis

Neurological Manifestations of Inflammatory Bowel Disease

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