Advertisement

International Journal of Clinical Pharmacy

, Volume 36, Issue 4, pp 679–683 | Cite as

Systematic review of severe acute liver injury caused by terbinafine

  • Jun Yan
  • Xiaolin Wang
  • Shengli ChenEmail author
Review Article

Abstract

Background Terbinafine is an effective antimicrobial agent against dermatophytes, cryptococcus and other fungi. It is the preferred drug to treat onychomycosis. However, severe acute hepatitis from oral terbinafine administration has been recently reported. Aim To describe a representative case, and review the literature regarding the best evidence on treatment and prognosis of severe acute hepatitis caused by oral terbinafine. Methods The literature was searched for publications on severe hepatitis caused by terbinafine using MEDLINE, China Biology Medicine Disc, and the VIP Medical Information Resource System. Related references were searched manually. Results Seventeen English and three Chinese references of case reports were included after eliminating duplicate publications. No randomized control studies were found. Liver enzyme levels were found to have been increased significantly. Abdominal ultrasound demonstrated cholestasis. Conclusions Severe acute liver injury is a known, but unusual complication of terbinafine exposure. The prognosis is often good with appropriate treatment. Liver function assessment before treatment and periodic monitoring 4–6 weeks after initiation of treatment is recommended.

Keywords

Adverse reactions Hepatitis Systematic review Terbinafine 

Notes

Acknowledgments

Lei CUI, Xiaodan LV: Jinan Infectious Disease Hospital, Liver Disease Diagnosis and Treatment Center of Shandong Province, Jinan, 250013 China.

Funding

No funding was received to support this work.

Conflicts of interest

The authors have no conflicts of interest.

References

  1. 1.
    Hay RJ. Risk/benefit ratio of modern antifungal therapy: focus on hepatic reactions. J Am Acad Dermatol. 1993;29:S50–4.PubMedCrossRefGoogle Scholar
  2. 2.
    Gupta AK, del Rosso JQ, Lynde CW, Brown GH, Shear NH. Hepatitis associated with terbinafine therapy: three case reports and a review of the literature. Clin Exp Dermatol. 1998;23:64–7.PubMedCrossRefGoogle Scholar
  3. 3.
    Itraconazole, terbinafine possibly linked to liver failure. Am J Health Syst Pharm. 2001; 58: 1076.Google Scholar
  4. 4.
    Hepatic reactions with terbinafine. Aust Adverse Drug React Bull. 2008;27:2.Google Scholar
  5. 5.
    Xiao Z, Yanqing LI. Japan revised terbinafinewarning. Chin Pharmacist. 2004;7:479.Google Scholar
  6. 6.
    Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.PubMedCentralPubMedCrossRefGoogle Scholar
  7. 7.
    Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.PubMedCrossRefGoogle Scholar
  8. 8.
    Lowe G, Green C, Jennings P. Hepatitis associated with terbinafine treatment. BMJ. 1993;306:248.PubMedCentralPubMedCrossRefGoogle Scholar
  9. 9.
    van ‘t Wout JW, Herrmann WA, De Vries RA, Stricker BH. Terbinafine-associated hepatic injury. J Hepatol. 1994;21:115–7.CrossRefGoogle Scholar
  10. 10.
    Lazaros GA, Papatheodoridis GV, Delladetsima JK, Tassopoulos NC. Terbinafine-induced cholestatic liver disease. J Hepatol. 1996;24:753–6.PubMedCrossRefGoogle Scholar
  11. 11.
    Dwyer CM, White MI, Sinclair TS. Cholestatic jaundice due to terbinafine. Br J Dermatol. 1997;136:976–7.PubMedCrossRefGoogle Scholar
  12. 12.
    Mallat A, Zafrani ES, Metreau JM, Dhumeaux D. Terbinafine-induced prolonged cholestasis with reduction of interlobular bile ducts. Dig Dis Sci. 1997;42:1486–8.PubMedCrossRefGoogle Scholar
  13. 13.
    Fernandes NF, Geller SA, Fong TL. Terbinafine hepatotoxicity: case report and review of the literature. Am J Gastroenterol. 1998;93:459–60.PubMedCrossRefGoogle Scholar
  14. 14.
    Gupta AK, Porges AJ. Hypersensitivity syndrome reaction to oral terbinafine. Australas J Dermatol. 1998;39(3):171–2.PubMedCrossRefGoogle Scholar
  15. 15.
    Agarwal K, Manas DM, Hudson M. Terbinafine and fulminant hepatic failure. N Engl J Med. 1999;340:1292–3.PubMedCrossRefGoogle Scholar
  16. 16.
    Conjeevaram G, Vongthavaravat V, Sumner R, Koff RS. Terbinafine-induced hepatitis and pancytopenia. Dig Dis Sci. 2001;46:1714–6.PubMedCrossRefGoogle Scholar
  17. 17.
    Chambers WM, Millar A, Jain S, Burroughs AK. Terbinafine-induced hepatic dysfunction. Eur J Gastroenterol Hepatol. 2001;13:1115–8.PubMedCrossRefGoogle Scholar
  18. 18.
    Ajit C, Suvannasankha A, Zaeri N, Munoz SJ. Terbinafine-associated hepatotoxicity. Am J Med Sci. 2003;32:292–5.CrossRefGoogle Scholar
  19. 19.
    Agca E, Akcay A, Simsek H. Ursodeoxycholic acid for terbinafine-induced toxic hepatitis. Ann Pharmacother. 2004;38:1088–9.PubMedCrossRefGoogle Scholar
  20. 20.
    Xin S. Terbinafine hydrochloride caused by drug hepatic damage. Clin Med Chin. 2004;20:515.Google Scholar
  21. 21.
    Xiaoqin LV, Zhang X. Terbinafine cause cholestasis hepatitis one case. Herald Med. 2006;25:593.Google Scholar
  22. 22.
    Perveze Z, Johnson MW, Rubin RA, Sellers M, Zayas C, Jones JL, et al. Terbinafine-induced hepatic failure requiring liver transplantation. Liver Transpl. 2007;13:162–4.PubMedCrossRefGoogle Scholar
  23. 23.
    Kim BS, Jang HS, Jwa SW, Jang BS, Kim MB, Oh CK, et al. Generalized pustular psoriasis and hepatic dysfunction associated with oral terbinafine therapy. J Korean Med Sci. 2007;22:167–9.PubMedCentralPubMedCrossRefGoogle Scholar
  24. 24.
    Paredes AH, Lewis JH. Terbinafine-induced acute autoimmune hepatitis in the setting of hepatitis B virus infection. Ann Pharmacother. 2007;41:880–4.PubMedCrossRefGoogle Scholar
  25. 25.
    Gendre G, Buclin T, Morard I, Fontannaz J, Berney JL. Terbinafine induced hepatitis with persistent cholestasis. Rev Med Suisse. 2008;4:736–9.PubMedGoogle Scholar
  26. 26.
    Jing B, Yang Y. Terbinafine cause cholestasis hepatitis. ADRJ. 2008;10:284.Google Scholar
  27. 27.
    Tausch I, Bräutigam M, Weidinger G, Jones TC. Evaluation of 6 weeks treatment of terbinafine in tinea unguium in a double-blind trial comparing 6 and 12 weeks therapy. The Lagos V Study Group. Br J Dermatol. 1997;136(5):737–42.PubMedCrossRefGoogle Scholar
  28. 28.
    Gupta AK, Lynde CW, Konnikov N. Single-blind, randomized, prospective study of sequential itraconazole and terbinafine pulse compared with terbinafine pulse for the treatment of toenail onychomycosis. J Am Acad Dermatol. 2001;44(3):485–91.PubMedCrossRefGoogle Scholar
  29. 29.
    Baran R, Feuilhade M, Combernale P, Datry A, Goettmann S, Pietrini P, et al. A randomized trial of amorolfine 5% solution nail lacquer combined with oral terbinafine compared with terbinafine alone in the treatment of dermatophytic toenail onychomycoses affecting the matrix region. Br J Dermatol. 2000;142(6):1177–83.PubMedCrossRefGoogle Scholar
  30. 30.
    De Backer M, De Vroey C, Lesaffre E, Scheys I, De Keyser P. Twelve weeks of continuous oral therapy for toenail onychomycosis caused by dermatophytes: a double-blind comparative trial of terbinafine 250 mg/day versus itraconazole 200 mg/day. J Am Acad Dermatol. 1998;38(5 Pt 3):S57–63.PubMedCrossRefGoogle Scholar
  31. 31.
    Chang CH, Young-Xu Y, Kurth T, Orav JE, Chan AK. The safety of oral antifungal treatments for superficial dermatophytosis and onychomycosis: a meta-analysis. Am J Med. 2007;120:791–8.PubMedCrossRefGoogle Scholar
  32. 32.
    Gupta AK, Ryder JE, Johnson AM. Cumulative meta-analysis of systemic antifungal agents for the treatment of onychomycosis. Br J Dermatol. 2004;150:537–44.PubMedCrossRefGoogle Scholar
  33. 33.
    Krob AH, Fleischer AB Jr, D’Agostino R Jr, Feldman SR. Terbinafine is more effective than itraconazole in treating toenail onychomycosis: results from a meta-analysis of randomized controlled trials. J Cutan Med Surg. 2003;7:306–11.PubMedCrossRefGoogle Scholar
  34. 34.
    Casciano J, Amaya K, Doyle J, Arikian S, Shear N, Haspel M, Kahler K. Economic analysis of oral and topical therapies for onychomycosis of the toenails and fingernails. Manag Care. 2003;12:47–54.PubMedGoogle Scholar
  35. 35.
    Haugh M, Helou S, Boissel JP, Cribier BJ. Terbinafine in fungal infections of the nails: a meta-analysis of randomized clinical trials. Br J Dermatol. 2002;147:118–21.PubMedCrossRefGoogle Scholar
  36. 36.
    Gupta AK. Treatment of dermatophyte toenail onychomycosis in the United States. A pharmacoeconomic analysis. J Am Podiatr Med Assoc. 2002;92:272–86.PubMedCrossRefGoogle Scholar
  37. 37.
    Gupta AK, Lambert J. Pharmacoeconomic analysis of the new oral antifungal agents used to treat toenail onychomycosis in the USA. Int J Dermatol. 1999;38:S53–64.CrossRefGoogle Scholar
  38. 38.
    De Doncker P. Itraconazole and terbinafine in perspective: from petri dish to patient. J Eur Acad Dermatol Venereol. 1999;12:S10–6.PubMedGoogle Scholar
  39. 39.
    Marchetti A, Piech CT, McGhan WF, Neugut AI, Smith BT. Pharmacoeconomic analysis of oral therapies for onychomycosis: a US model. Clin Ther. 1996;18:757–77.PubMedCrossRefGoogle Scholar

Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014

Authors and Affiliations

  1. 1.Jinan City Hospital for Skin Diseases Prevention and TreatmentJinanChina
  2. 2.Shandong Provincial Institute of Dermatology and VenereologyShandong Acdemy of Medical SciencesJinanChina

Personalised recommendations