Publication Name	World Journal of Hepatology
Manuscript ID	9392
Country	Italy

Received	2014-02-12 14:54
Peer-Review Started	2014-02-12 21:36
To Make the First Decision	2014-03-12 16:42
Return for Revision	2014-03-20 20:42
Revised	2014-03-26 17:38
Second Decision	2014-07-17 14:17
Accepted by Journal Editor-in-Chief
Accepted by Company Editor-in-Chief	2014-07-17 14:34
Articles in Press	2014-07-17 14:50
Publication Fee Transferred
Edit the Manuscript by Language Editor
Typeset the Manuscript	2014-08-28 14:03
Publish the Manuscript Online	2014-08-29 07:54

ISSN	1948-5182 (online)
Open Access
Copyright
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Category	Pharmacology & Pharmacy
Manuscript Type	Systematic Reviews
Article Title	Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database
Manuscript Source	Invited Manuscript
All Author List	Emanuel Raschi, Elisabetta Poluzzi, Ariola Koci, Paolo Caraceni and Fabrizio De Ponti
Funding Agency and Grant Number
Corresponding Author	Fabrizio De Ponti, MD, PhD, Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio, 48, I-40126 Bologna BO, Italy. fabrizio.deponti@unibo.it
Key Words	Drug-induced hepatotoxicity; Antimycotics; Drug safety; Pharmacovigilance; Spontaneous reporting systems
Core Tip	The recent regulatory interventions (United States restriction and Europe suspension) concerning ketoconazole for drug-induced liver injury (DILI) poses a prescribing challenge to clinicians, who should now carefully consider safer therapeutic alternatives. Data mining of FAERS database (2004-2011) highlighted that: (1) antimycotics are involved in approximately 3% of DILI cases (including acute liver failure events); (2) virtually all systemic antimycotics (e.g., azole derivatives), are associated with disproportionality signals; careful monitoring is therefore recommended, especially in critical poly-treated patients with multiple comorbidities; and (3) topical antimycotics, as expected, do not generate a post-marketing signal of DILI, thus indicating the accuracy of our approach.Data mining of FAERS database (2004-2011) highlighted that: (a) antimycotics are involved in approximately 3% of DILI cases (including acute liver failure events); (b) virtually all systemic antimycotics (e.g., azole derivatives), are associated with disproportionality signals; careful monitoring is therefore recommended, especially in critical poly-treated patients with multiple comorbidities; (c) topical antimycotics, as expected, do not generate a post-marketing signal of DILI, thus indicating the accuracy of our approach.
Publish Date	2014-08-29 07:54
Citation	Raschi E, Poluzzi E, Koci A, Caraceni P, De Ponti F. Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database. World J Hepatol 2014; 6(8): 601-612
URL	http://www.wjgnet.com/1948-5182/full/v6/i8/601.htm
DOI	http://dx.doi.org/10.4254/wjh.v6.i8.601

Full Article (PDF)	WJH-6-601.pdf
Full Article (Word)	WJH-6-601.doc
Manuscript File	9392-Review.docx
Answering Reviewers	9392-Answering reviewers.pdf
Copyright License Agreement	9392-Copyright assignment.pdf
Peer-review Report	9392-Peer review(s).pdf
Scientific Misconduct Check	9392-Review.docx
Scientific Editor Work List	9392-Scientific editor work list.pdf