title: [Trends in drug-induced liver injury based on reports of adverse reactions to PMDA in Japan].
abstract: Reports on drug-related adverse reactions from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated under the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety measures. Although association between the medicine and the adverse event has not been clearly evaluated, and an incidence may be redundantly reported, this information would be useful to roughly grasp the current status of drug-related adverse reactions. In the present study, we analyzed the incidence of drug-induced liver injury by screening the open-source data publicized by the homepage of Pharmaceutical and Medical Devices Agency from 2005 to 2011 fiscal years. Major drug-classes suspected to cause general drug-induced liver injury were antineoplastics, anti-inflammatory agents/common cold drugs, chemotherapeutics including antituberculous drugs, antidiabetics, antiulcers and antiepileptics. In addition, reported cases for fulminant hepatitis were also summarized. We found that antituberculous isoniazid and antineoplastic tegafur-uracil were the top two suspected drugs. These results might deepen understanding of current situations for the drug-induced liver injury in Japan.
authors.affiliation: Division of Medicinal Safety Science, National Institute of Health Sciences, 1-18-1 Kamiyoga, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan.
authors.forename: Chie
authors.initials: C
authors.lastname: Sudo
authors.forename: Keiko
authors.initials: K
authors.lastname: Maekawa
authors.forename: Katsunori
authors.initials: K
authors.lastname: Segawa
authors.forename: Tadaaki
authors.initials: T
authors.lastname: Hanatani
authors.forename: Kimie
authors.initials: K
authors.lastname: Sai
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Saito
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000890:Anti-Infective Agents / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D015994:Incidence; D007564:Japan; D017114:Liver Failure, Acute / Q000139:chemically induced / Q000453:epidemiology; D005641:Tegafur / Q000009:adverse effects; D013997:Time Factors; D014498:Uracil / Q000009:adverse effects
chemical_list: D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D000970:Antineoplastic Agents; D005641:Tegafur; D014498:Uracil