A prospective nationwide study of drug-induced liver injury in korea

Ki Tae Suk, Dong Joon Kim, Chang Hoon Kim, Seung Ha Park, Jai Hoon Yoon, Yeon Soo Kim, Gwang Ho Baik, Jin Bong Kim, Young Oh Kweon, Byung Ik Kim, Seok Hyun Kim, In Hee Kim, Ju Hyun Kim, Soon Woo Nam, Yong Han Paik, Jeong Ill Suh, Joo Hyun Sohn, Byung Min Ahn, Soon-Ho Um, Heon Ju Lee & 7 others Mong Cho, Myoung Kuk Jang, Sung Kyu Choi, Seong Gyu Hwang, Ho Taik Sung, Jong Young Choi, Kwang Hyub Han

Research output: Contribution to journalArticle

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Abstract

OBJECTIVES:To address a growing concern about drug-induced liver injury (DILI), a nationwide study was performed to investigate the significance of DILI in Korea.METHODS:From May 2005 to May 2007, cases of DILI (alanine transferase 3 × upper normal limit or total bilirubin 2 × upper normal limit) from 17 referral university hospitals were prospectively enrolled. Adjudication by the seven review boards was considered for the confirmation of causality and the Roussel Uclaf Causality Assessment Method (RUCAM) scale was used.RESULTS:A total of 371 cases were diagnosed with DILI. The extrapolated incidence of hospitalization at university hospital in Korea was 12/100,000 persons/year. The causes included herbal medications (102, 27.5%), prescription or non-prescription medications (101, 27.3%), health foods or dietary supplements (51, 13.7%), medicinal herbs or plants (35, 9.4%), folk remedies (32, 8.6%), combined (30, 8.2%), herbal preparations (12, 3.2%), and others (8, 2.2%). Nine cases were linked to acetaminophen. The frequencies of hepatocellular, mixed, and cholestatic types were 76.3, 14.8, and 8.9%, respectively. A total of 234 cases met the criteria for Hy's law. Five patients died or underwent transplantation. Twenty-five cases (21 herbs and 4 medications) did not meet the time-to-onset criteria of the RUCAM.CONCLUSIONS:DILI appears to be a highly relevant health problem in Korea. Herbal medications are the principal cause of DILI. A more objective and reproducible causality assessment tool is strongly desired as the RUCAM scale frequently undercounts the cases caused by herbs owing to a lack of previous information and incompatible time criteria.

Original languageEnglish
Pages (from-to)1380-1387
Number of pages8
JournalAmerican Journal of Gastroenterology
Volume107
Issue number9
DOIs
Publication statusPublished - 2012 Sep 1

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Chemical and Drug Induced Liver Injury
Korea
Causality
Prospective Studies
Medicinal Plants
Dietary Supplements
Plant Preparations
Health
Traditional Medicine
Acetaminophen
Transferases
Bilirubin
Alanine
Prescriptions
Hospitalization
Referral and Consultation
Transplantation
Incidence

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Suk, K. T., Kim, D. J., Kim, C. H., Park, S. H., Yoon, J. H., Kim, Y. S., ... Han, K. H. (2012). A prospective nationwide study of drug-induced liver injury in korea. American Journal of Gastroenterology, 107(9), 1380-1387. https://doi.org/10.1038/ajg.2012.138

A prospective nationwide study of drug-induced liver injury in korea. / Suk, Ki Tae; Kim, Dong Joon; Kim, Chang Hoon; Park, Seung Ha; Yoon, Jai Hoon; Kim, Yeon Soo; Baik, Gwang Ho; Kim, Jin Bong; Kweon, Young Oh; Kim, Byung Ik; Kim, Seok Hyun; Kim, In Hee; Kim, Ju Hyun; Nam, Soon Woo; Paik, Yong Han; Suh, Jeong Ill; Sohn, Joo Hyun; Ahn, Byung Min; Um, Soon-Ho; Lee, Heon Ju; Cho, Mong; Jang, Myoung Kuk; Choi, Sung Kyu; Hwang, Seong Gyu; Sung, Ho Taik; Choi, Jong Young; Han, Kwang Hyub.

In: American Journal of Gastroenterology, Vol. 107, No. 9, 01.09.2012, p. 1380-1387.

Research output: Contribution to journalArticle

Suk, KT, Kim, DJ, Kim, CH, Park, SH, Yoon, JH, Kim, YS, Baik, GH, Kim, JB, Kweon, YO, Kim, BI, Kim, SH, Kim, IH, Kim, JH, Nam, SW, Paik, YH, Suh, JI, Sohn, JH, Ahn, BM, Um, S-H, Lee, HJ, Cho, M, Jang, MK, Choi, SK, Hwang, SG, Sung, HT, Choi, JY & Han, KH 2012, 'A prospective nationwide study of drug-induced liver injury in korea', American Journal of Gastroenterology, vol. 107, no. 9, pp. 1380-1387. https://doi.org/10.1038/ajg.2012.138
Suk, Ki Tae ; Kim, Dong Joon ; Kim, Chang Hoon ; Park, Seung Ha ; Yoon, Jai Hoon ; Kim, Yeon Soo ; Baik, Gwang Ho ; Kim, Jin Bong ; Kweon, Young Oh ; Kim, Byung Ik ; Kim, Seok Hyun ; Kim, In Hee ; Kim, Ju Hyun ; Nam, Soon Woo ; Paik, Yong Han ; Suh, Jeong Ill ; Sohn, Joo Hyun ; Ahn, Byung Min ; Um, Soon-Ho ; Lee, Heon Ju ; Cho, Mong ; Jang, Myoung Kuk ; Choi, Sung Kyu ; Hwang, Seong Gyu ; Sung, Ho Taik ; Choi, Jong Young ; Han, Kwang Hyub. / A prospective nationwide study of drug-induced liver injury in korea. In: American Journal of Gastroenterology. 2012 ; Vol. 107, No. 9. pp. 1380-1387.
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abstract = "OBJECTIVES:To address a growing concern about drug-induced liver injury (DILI), a nationwide study was performed to investigate the significance of DILI in Korea.METHODS:From May 2005 to May 2007, cases of DILI (alanine transferase 3 × upper normal limit or total bilirubin 2 × upper normal limit) from 17 referral university hospitals were prospectively enrolled. Adjudication by the seven review boards was considered for the confirmation of causality and the Roussel Uclaf Causality Assessment Method (RUCAM) scale was used.RESULTS:A total of 371 cases were diagnosed with DILI. The extrapolated incidence of hospitalization at university hospital in Korea was 12/100,000 persons/year. The causes included herbal medications (102, 27.5{\%}), prescription or non-prescription medications (101, 27.3{\%}), health foods or dietary supplements (51, 13.7{\%}), medicinal herbs or plants (35, 9.4{\%}), folk remedies (32, 8.6{\%}), combined (30, 8.2{\%}), herbal preparations (12, 3.2{\%}), and others (8, 2.2{\%}). Nine cases were linked to acetaminophen. The frequencies of hepatocellular, mixed, and cholestatic types were 76.3, 14.8, and 8.9{\%}, respectively. A total of 234 cases met the criteria for Hy's law. Five patients died or underwent transplantation. Twenty-five cases (21 herbs and 4 medications) did not meet the time-to-onset criteria of the RUCAM.CONCLUSIONS:DILI appears to be a highly relevant health problem in Korea. Herbal medications are the principal cause of DILI. A more objective and reproducible causality assessment tool is strongly desired as the RUCAM scale frequently undercounts the cases caused by herbs owing to a lack of previous information and incompatible time criteria.",
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AU - Suk, Ki Tae

AU - Kim, Dong Joon

AU - Kim, Chang Hoon

AU - Park, Seung Ha

AU - Yoon, Jai Hoon

AU - Kim, Yeon Soo

AU - Baik, Gwang Ho

AU - Kim, Jin Bong

AU - Kweon, Young Oh

AU - Kim, Byung Ik

AU - Kim, Seok Hyun

AU - Kim, In Hee

AU - Kim, Ju Hyun

AU - Nam, Soon Woo

AU - Paik, Yong Han

AU - Suh, Jeong Ill

AU - Sohn, Joo Hyun

AU - Ahn, Byung Min

AU - Um, Soon-Ho

AU - Lee, Heon Ju

AU - Cho, Mong

AU - Jang, Myoung Kuk

AU - Choi, Sung Kyu

AU - Hwang, Seong Gyu

AU - Sung, Ho Taik

AU - Choi, Jong Young

AU - Han, Kwang Hyub

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N2 - OBJECTIVES:To address a growing concern about drug-induced liver injury (DILI), a nationwide study was performed to investigate the significance of DILI in Korea.METHODS:From May 2005 to May 2007, cases of DILI (alanine transferase 3 × upper normal limit or total bilirubin 2 × upper normal limit) from 17 referral university hospitals were prospectively enrolled. Adjudication by the seven review boards was considered for the confirmation of causality and the Roussel Uclaf Causality Assessment Method (RUCAM) scale was used.RESULTS:A total of 371 cases were diagnosed with DILI. The extrapolated incidence of hospitalization at university hospital in Korea was 12/100,000 persons/year. The causes included herbal medications (102, 27.5%), prescription or non-prescription medications (101, 27.3%), health foods or dietary supplements (51, 13.7%), medicinal herbs or plants (35, 9.4%), folk remedies (32, 8.6%), combined (30, 8.2%), herbal preparations (12, 3.2%), and others (8, 2.2%). Nine cases were linked to acetaminophen. The frequencies of hepatocellular, mixed, and cholestatic types were 76.3, 14.8, and 8.9%, respectively. A total of 234 cases met the criteria for Hy's law. Five patients died or underwent transplantation. Twenty-five cases (21 herbs and 4 medications) did not meet the time-to-onset criteria of the RUCAM.CONCLUSIONS:DILI appears to be a highly relevant health problem in Korea. Herbal medications are the principal cause of DILI. A more objective and reproducible causality assessment tool is strongly desired as the RUCAM scale frequently undercounts the cases caused by herbs owing to a lack of previous information and incompatible time criteria.

AB - OBJECTIVES:To address a growing concern about drug-induced liver injury (DILI), a nationwide study was performed to investigate the significance of DILI in Korea.METHODS:From May 2005 to May 2007, cases of DILI (alanine transferase 3 × upper normal limit or total bilirubin 2 × upper normal limit) from 17 referral university hospitals were prospectively enrolled. Adjudication by the seven review boards was considered for the confirmation of causality and the Roussel Uclaf Causality Assessment Method (RUCAM) scale was used.RESULTS:A total of 371 cases were diagnosed with DILI. The extrapolated incidence of hospitalization at university hospital in Korea was 12/100,000 persons/year. The causes included herbal medications (102, 27.5%), prescription or non-prescription medications (101, 27.3%), health foods or dietary supplements (51, 13.7%), medicinal herbs or plants (35, 9.4%), folk remedies (32, 8.6%), combined (30, 8.2%), herbal preparations (12, 3.2%), and others (8, 2.2%). Nine cases were linked to acetaminophen. The frequencies of hepatocellular, mixed, and cholestatic types were 76.3, 14.8, and 8.9%, respectively. A total of 234 cases met the criteria for Hy's law. Five patients died or underwent transplantation. Twenty-five cases (21 herbs and 4 medications) did not meet the time-to-onset criteria of the RUCAM.CONCLUSIONS:DILI appears to be a highly relevant health problem in Korea. Herbal medications are the principal cause of DILI. A more objective and reproducible causality assessment tool is strongly desired as the RUCAM scale frequently undercounts the cases caused by herbs owing to a lack of previous information and incompatible time criteria.

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