Raschi E, Poluzzi E, Koci A, Caraceni P, Ponti FD. 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 [PMID: 25232453 DOI: 10.4254/wjh.v6.i8.601]
Corresponding Author of This Article
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
Research Domain of This Article
Pharmacology & Pharmacy
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Original Article
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World J Hepatol. Aug 27, 2014; 6(8): 601-612 Published online Aug 27, 2014. doi: 10.4254/wjh.v6.i8.601
Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database
Emanuel Raschi, Elisabetta Poluzzi, Ariola Koci, Paolo Caraceni, Fabrizio De Ponti
Emanuel Raschi, Elisabetta Poluzzi, Ariola Koci, Paolo Caraceni, Fabrizio De Ponti, Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, I-40126 Bologna BO, Italy
Author contributions: Raschi E and De Ponti F conceived the study; Koci A extracted data and performed statistical analysis; Raschi E drafted the first version of the manuscript; Poluzzi E, Caraceni P and De Ponti F provided substantial contribution to the discussion; all authors provided comments to the first draft and approved the final version of the manuscript.
Correspondence to: 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
Telephone: +39-051-2091805 Fax: +39-051-2091780
Received: February 10, 2014 Revised: March 26, 2014 Accepted: July 17, 2014 Published online: August 27, 2014 Processing time: 199 Days and 13 Hours
Core Tip
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.
