PMID- 23802849
OWN - NLM
STAT- MEDLINE
DCOM- 20140206
LR  - 20130716
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 38
IP  - 4
DP  - 2013 Aug
TI  - Neurological events with tumour necrosis factor alpha inhibitors reported to the 
      Food and Drug Administration Adverse Event Reporting System.
PG  - 388-96
LID - 10.1111/apt.12385 [doi]
AB  - BACKGROUND: The association between inhibition of tumour necrosis factor alpha 
      (TNF-alpha) and new onset of neurological adverse events (AEs) is unclear. AIMS: To 
      evaluate neurological AEs with TNF-alpha inhibitors reported to the Food and Drug 
      Administration Adverse Event Reporting System (FAERS) utilising a standardised 
      scoring tool for drug-induced AEs. METHODS: A search of FAERS for neurological 
      AEs (January 1, 2000 to December 31, 2009) reported with infliximab, adalimumab, 
      certolizumab and etanercept was performed. Full-text reports were accessed using 
      the Freedom of Information Act and scored using Naranjo score, while accounting 
      for temporal association, previous conclusive reports of the neurological AE with 
      any TNF-alpha inhibitor, and alternate explanations including underlying disease, 
      concomitant medications and comorbidities, such as diabetes mellitus. RESULTS: 
      There were 772 reports. Most were in patients who had rheumatoid arthritis (393, 
      50.9%) followed by inflammatory bowel disease (140, 18.1%). No significant 
      differences in age or gender were seen between IBD patients compared with 
      rheumatological diseases (P = 0.584 and P = 0.055 respectively). Etanercept was 
      reported most (327, 42.4%) followed by infliximab (276, 35.8%) (P = 0.008). 
      Peripheral neuropathy was the most common neurological AE (296 reports, 38.3%) 
      followed by central nervous system and/or spinal cord demyelination (153 reports, 
      19.8%). Majority (551, 71.4%) of the reports were of 'possible' AE with the 
      remaining 'probable' AE and none identified as 'definite' AE. CONCLUSION: While 
      several neurological AEs have been described, definite association between de 
      novo development of these AEs and exposure to TNF-alpha inhibitors was not 
      established using the Naranjo score.
CI  - (c) 2013 John Wiley & Sons Ltd.
FAU - Deepak, P
AU  - Deepak P
AD  - Department of Gastroenterology, Research Institute, NorthShore University Health 
      System, Evanston, IL 60201, USA.
FAU - Stobaugh, D J
AU  - Stobaugh DJ
FAU - Sherid, M
AU  - Sherid M
FAU - Sifuentes, H
AU  - Sifuentes H
FAU - Ehrenpreis, E D
AU  - Ehrenpreis ED
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130626
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Child
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Inflammatory Bowel Diseases/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Nervous System Diseases/*chemically induced
MH  - Tumor Necrosis Factor-alpha/adverse effects/*antagonists & inhibitors
MH  - United States
MH  - United States Food and Drug Administration
MH  - Young Adult
EDAT- 2013/06/28 06:00
MHDA- 2014/02/07 06:00
CRDT- 2013/06/28 06:00
PHST- 2013/04/19 00:00 [received]
PHST- 2013/05/16 00:00 [revised]
PHST- 2013/05/22 00:00 [revised]
PHST- 2013/06/04 00:00 [accepted]
PHST- 2013/06/28 06:00 [entrez]
PHST- 2013/06/28 06:00 [pubmed]
PHST- 2014/02/07 06:00 [medline]
AID - 10.1111/apt.12385 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2013 Aug;38(4):388-96. doi: 10.1111/apt.12385. Epub 2013 
      Jun 26.