American Journal of Internal Medicine

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A Patient with Drug-Induced Hepatic Injury Caused by a Switch to Generic Bezafibrate

Received: 23 May 2014    Accepted: 09 July 2014    Published: 20 July 2014
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Abstract

A 76-year-old woman with primary biliary cirrhosis and hypertension had been treated with a combination of oral ursodeoxycholic acid, bezafibrate and benidipine hydrochloride. After switching from brand name to generic bezafibrate, her liver injury became exacerbated. Her lymphocytes reacted with generic bezafibrate on a drug-lymphocyte stimulation test (DLST), indicating that her liver injury was likely caused by the switch to generic bezafibrate. Treatment with this agent was stopped, improving her liver function. These findings indicate that all forms of bezafibrate are not equal, that this generic formulation caused liver injury to this patient, and that DLST was useful diagnostically.

DOI 10.11648/j.ajim.20140204.12
Published in American Journal of Internal Medicine (Volume 2, Issue 4, July 2014)
Page(s) 63-66
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Drug-Induced Hepatic Injury, Bezafibrate, Fibrate, Drug-Lymphocyte Stimulation Test (DLST), Primary Biliary Cirrhosis (PBC)

References
[1] Takikawa H, Takamori Y, Hisamochi A, et al. Draft new drug-induced liver damage diagnostic criteria: Revision of diagnostic criteria by the International Consensus Committee. Kanzo (in Japanese). 2003; 44: 176-9.
[2] Takikawa H, Onji M, Takamori Y, Murata Y, Taniguchi H, Ito T, et al. DDW-J 2004 Workshop draft drug-induced liver damage diagnostic criteria. Kanzo (in Japanese). 2005; 46: 85-90.
[3] Watanabe M, Shibuya A, Miura Y, Adachi S, Okuwaki Y, Ono K, et al. Validity study for the DDW-J 2004 Drug-Induced Liver Damage Workshop scoring system. Kanzo (in Japanese). 2007; 48: 219-226.
[4] Yasuda T, Fukui T, Kawase Y, Okita M, Oyamada Y, Kawabata K. One rhabdomyolysis patient who developed acute kidney and liver failure due to bezafibrate administration. Shojinkai Medical Journal. 2012; 51: 127-131.
[5] Koga H, Sakisaka S, ohishi M, Ohishi M, Sata M, Tanikawa K. Nuclear DNA fragmentation and expression of Bcl-2 in primary biliary cirrhosis. Hepatology. 1997; 25: 1084-1997.
[6] Sakisaka S, Kawaguchi T, Taniguchi E, Harada S, Sasatomi K, Koga H, et al. Alterations in tight junctions differbetween primary biliary cirrhosis and primary sclerosing cholangitis. Hepatology. 2001; 33: 1460-1468.
[7] Ishibashi T, Nakanuma Y, Ueno Y, Egawa H, Koike K, Komori A. et al. MHLW Refractory Disease Research Group on Diagnostic Guidelines for Primary Biliary Cirrhosis (2012): Refractory Hepatobiliary Disease Survey Group. Kanzo (in Japanese). 2012; 53: 633-686.
[8] Nasu T. Molecular epidemiological research on PPARα gene polymorphism and susceptibility to various types of hepatitis. Research Reports of Uehara Memorial Foundation. 2008; 22: 1-3.
[9] Naito H, Kamijima M, Yamanoshita O, Nakahara A, Katoh T, Tanaka N, et al. Differential effects of aging, drinking and exercise on serum cholesterol levels dependent on the PPARA-V 227A polymorphism. J Occup Health. 2007; 49: 353-362.
[10] Yamada Y, Tsuchihashi H. Comparison of efficacy, safety and economics of chestnut fibrates and bezafibrate. Journal of Medicine and Pharmaceutical Science. 2012; 67: 97-101.
[11] Takikawa H. Drug-induced liver damage and the drug lymphocyte stimulation test. Kanzo (in Japanese). 2001; 42: 445-447.
[12] Irie M, Yokoyama K, Sakurai K, Iwashita H, Ueda S, Morihara D, et al. One patient with drug-induced liver failure associated with severe jaundice due to long-term amlodipine and loxoprofen sodium administration. Kanzo (in Japanese). 2001; 51: 169-174.
[13] Horowitz RS, Feldhaus K, Dart RC, Stermitz FR, Beck JJ. The clinical spectrum of Jin Bu Huan toxicity. Arch Intern Med. 1998; 156: 899-903.
Author Information
  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Murakami Karindo Hospital, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

  • Department of Gastroenterology and Medicine, Fukuoka University, Faculty of Medicine, Fukuoka, Japan

Cite This Article
  • APA Style

    Makoto Irie, Kaoru Iwata, Akira Anan, Naoaki Tsuchiya, Atsushi Fukunaga, et al. (2014). A Patient with Drug-Induced Hepatic Injury Caused by a Switch to Generic Bezafibrate. American Journal of Internal Medicine, 2(4), 63-66. https://doi.org/10.11648/j.ajim.20140204.12

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    ACS Style

    Makoto Irie; Kaoru Iwata; Akira Anan; Naoaki Tsuchiya; Atsushi Fukunaga, et al. A Patient with Drug-Induced Hepatic Injury Caused by a Switch to Generic Bezafibrate. Am. J. Intern. Med. 2014, 2(4), 63-66. doi: 10.11648/j.ajim.20140204.12

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    AMA Style

    Makoto Irie, Kaoru Iwata, Akira Anan, Naoaki Tsuchiya, Atsushi Fukunaga, et al. A Patient with Drug-Induced Hepatic Injury Caused by a Switch to Generic Bezafibrate. Am J Intern Med. 2014;2(4):63-66. doi: 10.11648/j.ajim.20140204.12

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  • @article{10.11648/j.ajim.20140204.12,
      author = {Makoto Irie and Kaoru Iwata and Akira Anan and Naoaki Tsuchiya and Atsushi Fukunaga and Kazuhide Takata and Tanaka Takashi and Keiji Yokoyama and Daisuke Morihara and Yasuaki Takeyama and Satoshi Shakado and Tetsuro Sohda and Shotaro Sakisaka},
      title = {A Patient with Drug-Induced Hepatic Injury Caused by a Switch to Generic Bezafibrate},
      journal = {American Journal of Internal Medicine},
      volume = {2},
      number = {4},
      pages = {63-66},
      doi = {10.11648/j.ajim.20140204.12},
      url = {https://doi.org/10.11648/j.ajim.20140204.12},
      eprint = {https://download.sciencepg.com/pdf/10.11648.j.ajim.20140204.12},
      abstract = {A 76-year-old woman with primary biliary cirrhosis and hypertension had been treated with a combination of oral ursodeoxycholic acid, bezafibrate and benidipine hydrochloride. After switching from brand name to generic bezafibrate, her liver injury became exacerbated. Her lymphocytes reacted with generic bezafibrate on a drug-lymphocyte stimulation test (DLST), indicating that her liver injury was likely caused by the switch to generic bezafibrate. Treatment with this agent was stopped, improving her liver function. These findings indicate that all forms of bezafibrate are not equal, that this generic formulation caused liver injury to this patient, and that DLST was useful diagnostically.},
     year = {2014}
    }
    

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  • TY  - JOUR
    T1  - A Patient with Drug-Induced Hepatic Injury Caused by a Switch to Generic Bezafibrate
    AU  - Makoto Irie
    AU  - Kaoru Iwata
    AU  - Akira Anan
    AU  - Naoaki Tsuchiya
    AU  - Atsushi Fukunaga
    AU  - Kazuhide Takata
    AU  - Tanaka Takashi
    AU  - Keiji Yokoyama
    AU  - Daisuke Morihara
    AU  - Yasuaki Takeyama
    AU  - Satoshi Shakado
    AU  - Tetsuro Sohda
    AU  - Shotaro Sakisaka
    Y1  - 2014/07/20
    PY  - 2014
    N1  - https://doi.org/10.11648/j.ajim.20140204.12
    DO  - 10.11648/j.ajim.20140204.12
    T2  - American Journal of Internal Medicine
    JF  - American Journal of Internal Medicine
    JO  - American Journal of Internal Medicine
    SP  - 63
    EP  - 66
    PB  - Science Publishing Group
    SN  - 2330-4324
    UR  - https://doi.org/10.11648/j.ajim.20140204.12
    AB  - A 76-year-old woman with primary biliary cirrhosis and hypertension had been treated with a combination of oral ursodeoxycholic acid, bezafibrate and benidipine hydrochloride. After switching from brand name to generic bezafibrate, her liver injury became exacerbated. Her lymphocytes reacted with generic bezafibrate on a drug-lymphocyte stimulation test (DLST), indicating that her liver injury was likely caused by the switch to generic bezafibrate. Treatment with this agent was stopped, improving her liver function. These findings indicate that all forms of bezafibrate are not equal, that this generic formulation caused liver injury to this patient, and that DLST was useful diagnostically.
    VL  - 2
    IS  - 4
    ER  - 

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