Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system

Author:

Raschi Emanuel1,Poluzzi Elisabetta1,Koci Ariola1,Salvo Francesco23,Pariente Antoine234,Biselli Maurizio1,Moretti Ugo5,Moore Nicholas234ORCID,De Ponti Fabrizio1

Affiliation:

1. Department of Medical and Surgical Sciences; University of Bologna; Bologna Italy

2. University of Bordeaux, U657; F33000 Bordeaux France

3. INSERM U657; F33000 Bordeaux France

4. CIC Bordeaux CIC1401; F33000 Bordeaux France

5. Department of Public Health and Community Medicine; University of Verona; Verona Italy

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference43 articles.

1. Clinical features, diagnosis, and natural history of drug-induced liver injury;Hayashi;Semin Liver Dis,2014

2. Drug-induced liver injury throughout the drug development life cycle: Where we have been, where we are now, and where we are headed. Perspectives of a clinical hepatologist;Lewis;Pharmaceut Med,2013

3. Postmarketing safety surveillance: where does signal detection using electronic healthcare records fit into the big picture?;Coloma;Drug Saf,2013

4. Performance of pharmacovigilance signal-detection algorithms for the FDA adverse event reporting system;Harpaz;Clin Pharmacol Ther,2013

5. Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA adverse event reporting system (FAERS) database;Brinker;Drug Saf,2013

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