메뉴 건너뛰기




Volumn 11, Issue 4, 2012, Pages 500-512

Initially purported hepatotoxicity by Pelargonium sidoides: The dilemma of pharmacovigilance and proposals for improvement

Author keywords

Herb induced liver injury; Herbal hepatotoxicity; Pelargonium sidoides; Pelargonium sidoides questionable hepatotoxicity; Pharmacovigilance

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTINUCLEAR ANTIBODY; ASPARTATE AMINOTRANSFERASE; HERBACEOUS AGENT; INFLIXIMAB; NONSTEROID ANTIINFLAMMATORY AGENT; OLMESARTAN; PREDNISONE; PLANT EXTRACT; RESPIRATORY TRACT AGENT;

EID: 84861998435     PISSN: 16652681     EISSN: None     Source Type: Journal    
DOI: 10.1016/s1665-2681(19)31464-4     Document Type: Article
Times cited : (35)

References (45)
  • 1
    • 84876580367 scopus 로고    scopus 로고
    • Adverse drug reactions: History, terminology, classification, causality, frequency, preventability
    • In: Talbot J, Aronson JK, 6th. Ed. John Wiley & Sons, Ltd, DOI: 10.1002/9780470975053. ch1
    • Aronson JK. Adverse drug reactions: History, terminology, classification, causality, frequency, preventability. In: Talbot J, Aronson JK. Stephens' detection and evaluation of adverse drug reactions: principles and practice. 6th. Ed. John Wiley & Sons, Ltd.; 2011. DOI: 10.1002/9780470975053. ch1.
    • (2011) Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice
    • Aronson, J.K.1
  • 2
    • 78651521047 scopus 로고    scopus 로고
    • New postgraduate qualifications in pharmacovigilance from the Drug Safety Research Unit in the UK
    • Lynn E, Layton D, Shakir S. New postgraduate qualifications in pharmacovigilance from the Drug Safety Research Unit in the UK. Drug Saf 2011; 34: 89-91.
    • (2011) Drug Saf , vol.34 , pp. 89-91
    • Lynn, E.1    Layton, D.2    Shakir, S.3
  • 3
    • 34248383514 scopus 로고    scopus 로고
    • Guidelines for submitting adverse events reports for publication
    • International Society for Pharmacoepidemiology; International Society for Pharmacovigilance
    • Kelly WN, Arellano FM, Barnes J, Bergman U, Edwards RI, Fernandez AM, Freedman SB, et al; International Society for Pharmacoepidemiology; International Society for Pharmacovigilance. Guidelines for submitting adverse events reports for publication. Drug Saf 2007; 30: 367-73.
    • (2007) Drug Saf , vol.30 , pp. 367-373
    • Kelly, W.N.1    Arellano, F.M.2    Barnes, J.3    Bergman, U.4    Edwards, R.I.5    Fernandez, A.M.6    Freedman, S.B.7
  • 4
    • 77955586347 scopus 로고    scopus 로고
    • Completeness of published case reports on suspected adverse drug reactions
    • Impicciatore P, Mucci M. Completeness of published case reports on suspected adverse drug reactions. Drug Saf 2010; 30: 765-73.
    • (2010) Drug Saf , vol.30 , pp. 765-773
    • Impicciatore, P.1    Mucci, M.2
  • 5
    • 77950864495 scopus 로고    scopus 로고
    • Important elements for the diagnosis of drug-induced liver injury
    • Drug-Induced Liver Injury Network (DILIN)
    • Agarwal VK, McHutchison JG, Hoofnagle JH, Drug-Induced Liver Injury Network (DILIN). Important elements for the diagnosis of drug-induced liver injury. Clin Gastroenterol Hepatol 2010; 8: 463-70.
    • (2010) Clin Gastroenterol Hepatol , vol.8 , pp. 463-470
    • Agarwal, V.K.1    McHutchison, J.G.2    Hoofnagle, J.H.3
  • 6
    • 79952738754 scopus 로고    scopus 로고
    • Case reports of adverse effect of herbal medical products (HMPs): A quality assessment
    • Hung SK, Hillier S, Ernst E. Case reports of adverse effect of herbal medical products (HMPs): A quality assessment. Phytomedicine 2011; 18: 335-43.
    • (2011) Phytomedicine , vol.18 , pp. 335-343
    • Hung, S.K.1    Hillier, S.2    Ernst, E.3
  • 7
    • 77952499811 scopus 로고    scopus 로고
    • Hepatotoxicity by drugs and dietary supplements: Safety perspectives on clinical and regulatory issues
    • Teschke R. Hepatotoxicity by drugs and dietary supplements: safety perspectives on clinical and regulatory issues. Ann Hepatol 2009; 8: 184-95.
    • (2009) Ann Hepatol , vol.8 , pp. 184-195
    • Teschke, R.1
  • 8
    • 84860389774 scopus 로고    scopus 로고
    • Causality assessment methods in drug induced liver injury: Strengths and weaknesses
    • On behalf of the Spanish Group for the Study of Drug-Induced Liver Disease
    • Garcia-Cortés M, Stephens C, Lucena MI, Fernández Castañer A, Andrade RJ; On behalf of the Spanish Group for the Study of Drug-Induced Liver Disease. Causality assessment methods in drug induced liver injury: Strengths and weaknesses. J Hepatol 2011; 55: 683-91.
    • (2011) J Hepatol , vol.55 , pp. 683-691
    • Garcia-Cortés, M.1    Stephens, C.2    Lucena, M.I.3    Fernández Castañer, A.4    Andrade, R.J.5
  • 9
    • 70349832269 scopus 로고    scopus 로고
    • Suspected black cohosh hepatotoxicity-Causality assessment versus safety signal. Quality versus quantity
    • Teschke R, Bahre R, Genthner A, Fuchs J, Schmidt-Taenzer W, Wolff A. Suspected black cohosh hepatotoxicity-Causality assessment versus safety signal. Quality versus quantity. Maturitas 2009; 64: 141-42.
    • (2009) Maturitas , vol.64 , pp. 141-142
    • Teschke, R.1    Bahre, R.2    Genthner, A.3    Fuchs, J.4    Schmidt-Taenzer, W.5    Wolff, A.6
  • 10
    • 84874946342 scopus 로고    scopus 로고
    • EMA (European Medicines Agency), radix. Available at, [Issued March 31, 2011; accessed February 20, 2012]
    • EMA (European Medicines Agency). Assessment report on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix. Available at: http://www.ema.europa.eu/ docs/en_GB/document_library/Herbal_HMPC_assessment_report/2011 /06lWC500107717. pdf [Issued March 31, 2011; accessed February 20, 2012].
    • Ssessment Report On Pelargonium Sidoides DC And/or Pelargonium Reniforme Curt
  • 11
    • 84862212114 scopus 로고    scopus 로고
    • Hepatitis in connection with Umckaloabo®
    • Drug Commission of the German Medical Association (Arz neimittelkommission der Deutschen Arzteschaft), (article in German)
    • Drug Commission of the German Medical Association (Arz neimittelkommission der Deutschen Arzteschaft). Hepatitis in connection with Umckaloabo®. Deutsches Arzteblatt 2011; 108: C1399-C1400 (article in German).
    • (2011) Deutsches Arzteblatt , vol.108
  • 12
    • 84858259901 scopus 로고    scopus 로고
    • Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: Was causality adequately ascertained?
    • Teschke R, Frenzel C, Schulze J, Eickhoff A. Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: was causality adequately ascertained? Regul Toxicol Pharmacol 2012; 63: 1-9.
    • (2012) Regul Toxicol Pharmacol , vol.63 , pp. 1-9
    • Teschke, R.1    Frenzel, C.2    Schulze, J.3    Eickhoff, A.4
  • 13
    • 0027362542 scopus 로고
    • Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: Application to drug-induced liver injuries
    • Danan G, Bénichou C. Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol 1993; 46: 1323-30.
    • (1993) J Clin Epidemiol , vol.46 , pp. 1323-1330
    • Danan, G.1    Bénichou, C.2
  • 14
    • 0027448634 scopus 로고
    • Causality assessment of adverse reactions to drugs II. An original model for validation of drug causality assessment methods: Case reports with positive rechallenge
    • Bénichou C, Danan G, Flahault A. Causality assessment of adverse reactions to drugs-II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge. J Clin Epidemiol 1993; 46: 1331-6.
    • (1993) J Clin Epidemiol , vol.46 , pp. 1331-1336
    • Bénichou, C.1    Danan, G.2    Flahault, A.3
  • 15
    • 56549100205 scopus 로고    scopus 로고
    • Causality assessment in hepatotoxicity by drugs and dietary supplements
    • Teschke R, Schwarzenboeck A, Hennermann KH. Causality assessment in hepatotoxicity by drugs and dietary supplements. Br J Clin Pharmacol 2008; 66: 758-66.
    • (2008) Br J Clin Pharmacol , vol.66 , pp. 758-766
    • Teschke, R.1    Schwarzenboeck, A.2    Hennermann, K.H.3
  • 16
    • 84858192744 scopus 로고    scopus 로고
    • USP suspected herbal hepatotoxicity: Quality of causality assessment is more important than quantity of counted cases, not vice versa
    • Teschke R, Schmidt-Taenzer W, Wolff A. USP suspected herbal hepatotoxicity: Quality of causality assessment is more important than quantity of counted cases, not vice versa. Pharmacoepidemiol Drug Saf 2012; 21: 336-338.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , pp. 336-338
    • Teschke, R.1    Schmidt-Taenzer, W.2    Wolff, A.3
  • 17
    • 84862015812 scopus 로고    scopus 로고
    • Suspected herbal hepatotoxicity: Requirements for appropriate causality assessment by the US Pharmacopeia
    • [In press]
    • Teschke R, Schulze J. Suspected herbal hepatotoxicity: Requirements for appropriate causality assessment by the US Pharmacopeia. Drug Saf 2012 [In press].
    • (2012) Drug Saf
    • Teschke, R.1    Schulze, J.2
  • 18
    • 17444417807 scopus 로고    scopus 로고
    • Vitex agnus castus: A systematic review of adverse events
    • Daniele C, Thompson Coon J, Pittler MH, Ernst E. Vitex agnus castus: A systematic review of adverse events. Drug Saf 2005; 28: 319-32.
    • (2005) Drug Saf , vol.28 , pp. 319-332
    • Daniele, C.1    Thompson Coon, J.2    Pittler, M.H.3    Ernst, E.4
  • 19
    • 54849419085 scopus 로고    scopus 로고
    • Black cohosh (Cimicifuga racemosa): A systematic review of adverse events
    • Borrelli F, Ernst E. Black cohosh (Cimicifuga racemosa): a systematic review of adverse events. Am J Obstet Gynecol 2008; 199: 455-66.
    • (2008) Am J Obstet Gynecol , vol.199 , pp. 455-466
    • Borrelli, F.1    Ernst, E.2
  • 20
    • 66249108263 scopus 로고    scopus 로고
    • Potential risks associated with the use of herbal anti-obesity products
    • Chan TYK. Potential risks associated with the use of herbal anti-obesity products. Drug Saf 2009; 32: 453-6.
    • (2009) Drug Saf , vol.32 , pp. 453-456
    • Chan, T.Y.K.1
  • 21
    • 67650439353 scopus 로고    scopus 로고
    • Serenoa repens (Saw Palmetto): A systematic review of adverse events
    • Agbabiaka TB, Pittler MH, Wider B, Ernst E. Serenoa repens (Saw Palmetto): A systematic review of adverse events. Drug Saf 2009; 3: 637-47.
    • (2009) Drug Saf , vol.3 , pp. 637-647
    • Agbabiaka, T.B.1    Pittler, M.H.2    Wider, B.3    Ernst, E.4
  • 22
    • 79952755021 scopus 로고    scopus 로고
    • Safety of herbal products in Thailand: An analysis of reports in the Thai Health Product Vigilance Center Database from 2000 to 2008
    • Saokaew S, Suwankesawong W, Permsuwan U, Chaiyakunapruk N. Safety of herbal products in Thailand: An analysis of reports in the Thai Health Product Vigilance Center Database from 2000 to 2008. Drug Saf 2011; 34: 339-50.
    • (2011) Drug Saf , vol.34 , pp. 339-350
    • Saokaew, S.1    Suwankesawong, W.2    Permsuwan, U.3    Chaiyakunapruk, N.4
  • 23
    • 34548127579 scopus 로고    scopus 로고
    • Herbal hepatotoxicity
    • Seeff KB. Herbal hepatotoxicity. Clin Liv Dis 2007; 11: 577-96.
    • (2007) Clin Liv Dis , vol.11 , pp. 577-596
    • Seeff, K.B.1
  • 24
    • 84862013284 scopus 로고    scopus 로고
    • Pilot case control study of Chinese herbs and liver toxicity
    • Shaw D. Pilot case control study of Chinese herbs and liver toxicity. Drug Saf 2008; 31: 885-960.
    • (2008) Drug Saf , vol.31 , pp. 885-960
    • Shaw, D.1
  • 25
    • 70449133964 scopus 로고    scopus 로고
    • Herbal and dietary supplement hepatotoxici ty
    • Navarro VJ. Herbal and dietary supplement hepatotoxici ty. Semin Liver Dis 2009; 29: 373-82.
    • (2009) Semin Liver Dis , vol.29 , pp. 373-382
    • Navarro, V.J.1
  • 26
    • 68149157299 scopus 로고    scopus 로고
    • Drug-induced liver injury: What was new in 2008?
    • Liss G, Lewis JH. Drug-induced liver injury: what was new in 2008? Expert Opin Drug Metab Toxicol 2009; 5: 843-60.
    • (2009) Expert Opin Drug Metab Toxicol , vol.5 , pp. 843-860
    • Liss, G.1    Lewis, J.H.2
  • 27
    • 79959400420 scopus 로고    scopus 로고
    • Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: Is the liver unspecific Naranjo scale precise enough to as-certain causality?
    • Teschke R, Schmidt-Taenzer W, Wolff A. Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: Is the liver unspecific Naranjo scale precise enough to as-certain causality? Pharmacoepidemiol Drug Saf 2011; 20: 567-82.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , pp. 567-582
    • Teschke, R.1    Schmidt-Taenzer, W.2    Wolff, A.3
  • 28
    • 79959456952 scopus 로고    scopus 로고
    • Herb induced liver injury presumably caused by black cohosh: A survey of initially purported cases and herbal quality specifications
    • Teschke R, Schwarzenboeck A, Schmidt-Taenzer W, Wolff A, Hennermann KH. Herb induced liver injury presumably caused by black cohosh: A survey of initially purported cases and herbal quality specifications. Ann Hepatol 2011; 11: 249-59.
    • (2011) Ann Hepatol , vol.11 , pp. 249-259
    • Teschke, R.1    Schwarzenboeck, A.2    Schmidt-Taenzer, W.3    Wolff, A.4    Hennermann, K.H.5
  • 29
    • 56349138698 scopus 로고    scopus 로고
    • Kava hepatotoxicity: A clinical survey and critical analysis of 26 suspected cases
    • Teschke R, Schwarzenboeck A, Hennermann KH. Kava hepatotoxicity: a clinical survey and critical analysis of 26 suspected cases. Eur J Gastroenterol Hepatol 2008; 20: 1182-93.
    • (2008) Eur J Gastroenterol Hepatol , vol.20 , pp. 1182-1193
    • Teschke, R.1    Schwarzenboeck, A.2    Hennermann, K.H.3
  • 30
    • 78349260262 scopus 로고    scopus 로고
    • Kava hepatotoxicity-a clinical review
    • Teschke R. Kava hepatotoxicity-a clinical review. Ann Hepatol 2010; 9: 251-65.
    • (2010) Ann HePatol , vol.9 , pp. 251-265
    • Teschke, R.1
  • 31
    • 80855130652 scopus 로고    scopus 로고
    • Herbal hepatotoxicity by Greater Celandine (Chelidonium majus): Causality assessment of 22 spontaneous reports
    • Teschke R, Glass X, Schulze J. Herbal hepatotoxicity by Greater Celandine (Chelidonium majus): Causality assessment of 22 spontaneous reports. Regul Toxicol Pharmacol 2011; 61: 282-91.
    • (2011) Regul Toxicol Pharmacol , vol.61 , pp. 282-291
    • Teschke, R.1    Glass, X.2    Schulze, J.3
  • 32
    • 84856701742 scopus 로고    scopus 로고
    • Suspected Greater Celandine hepatotoxicity: Liver specific causality evaluation of published case reports from Europe
    • Teschke R, Glass X, Schulze J, Eickhoff A. Suspected Greater Celandine hepatotoxicity: Liver specific causality evaluation of published case reports from Europe. Eur Gastroenterol Hepatol 2012; 24: 270-80.
    • (2012) Eur Gastroenterol Hepatol , vol.24 , pp. 270-280
    • Teschke, R.1    Glass, X.2    Schulze, J.3    Eickhoff, A.4
  • 33
    • 0033547542 scopus 로고    scopus 로고
    • Accuracy of hepatic adverse drug reaction reporting in one English health region
    • Aithal GP, Rawlins MD, Day CP. Accuracy of hepatic adverse drug reaction reporting in one English health region. Br Med J 1999; 319: 1541.
    • (1999) Br Med J , vol.319 , pp. 1541
    • Aithal, G.P.1    Rawlins, M.D.2    Day, C.P.3
  • 34
    • 0033045249 scopus 로고    scopus 로고
    • The natural history of histologically proved drug induced liver disease
    • Aithal PG, Day CP. The natural history of histologically proved drug induced liver disease. Gut 1999; 44: 731-5.
    • (1999) Gut , vol.44 , pp. 731-735
    • Aithal, P.G.1    Day, C.P.2
  • 36
    • 18744376412 scopus 로고    scopus 로고
    • Drug-induced liver injury: An analysis of 461 incidences submitted to the Spanish registry over a 10 year period
    • Spanish Group for the Study of Drug induced Liver Disease
    • Andrade RJ, Lucena MI, Fernández MC, Pelaez G, Pachkoria K, García Ruiz E, García Muñoz B, et al; Spanish Group for the Study of Drug induced Liver Disease. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10 year period. Gastroenterology 2005: 129: 512-21.
    • (2005) Gastroenterology , vol.129 , pp. 512-521
    • Andrade, R.J.1    Lucena, M.I.2    Fernández, M.C.3    Pelaez, G.4    Pachkoria, K.5    García Ruiz, E.6    García Muñoz, B.7
  • 38
    • 80054848088 scopus 로고    scopus 로고
    • Acute hepatitis E infection accounts for some cases of suspected drug induced liver injury
    • For the Drug Induced Liver Injury Network (DILIN)
    • Davern TJ, Chalasani N, Fontana RJ, Hayashi PH, Protiva P, Kleiner DE, Engle RE, et al; For the Drug Induced Liver Injury Network (DILIN). Acute hepatitis E infection accounts for some cases of suspected drug induced liver injury. Gastroenterology 2011; 141: 1665-72.
    • (2011) Gastroenterology , vol.141 , pp. 1665-1672
    • Davern, T.J.1    Chalasani, N.2    Fontana, R.J.3    Hayashi, P.H.4    Protiva, P.5    Kleiner, D.E.6    Engle, R.E.7
  • 39
    • 58149333391 scopus 로고    scopus 로고
    • Suspected hepatotoxicity by Cimicifuga racemosa rhizoma (black cohosh, root): Critical analysis and structured causality assessment
    • Teschke R, Schwarzenboeck A. Suspected hepatotoxicity by Cimicifuga racemosa rhizoma (black cohosh, root): Critical analysis and structured causality assessment. Phyto medicine 2009; 16: 72-84.
    • (2009) Phyto Medicine , vol.16 , pp. 72-84
    • Teschke, R.1    Schwarzenboeck, A.2
  • 40
    • 67349287738 scopus 로고    scopus 로고
    • Black cohosh hepatotoxicity: Quantitative causality evaluation in nine suspected cases
    • Teschke R, Bahre R, Fuchs J, Wolff A. Black cohosh hepatotoxicity: quantitative causality evaluation in nine suspected cases. Menopause 2009; 16: 956-65.
    • (2009) Menopause , vol.16 , pp. 956-965
    • Teschke, R.1    Bahre, R.2    Fuchs, J.3    Wolff, A.4
  • 41
    • 68249138704 scopus 로고    scopus 로고
    • Suspected black cohosh hepatotoxicity Challenges and pitfalls of causality assessment
    • Teschke R, Bahre R, Genthner A, Fuchs J, Schmidt-Taenzer W, Wolff W. Suspected black cohosh hepatotoxicity Challenges and pitfalls of causality assessment. Maturitas 2009; 63: 302-14.
    • (2009) Maturitas , vol.63 , pp. 302-314
    • Teschke, R.1    Bahre, R.2    Genthner, A.3    Fuchs, J.4    Schmidt-Taenzer, W.5    Wolff, W.6
  • 42
    • 77949379937 scopus 로고    scopus 로고
    • Black cohosh and suspected hepatotoxicity-inconsistencies, confounding variables, and prospective use of a diagnostic causality algorithm: A critical review
    • Teschke R. Black cohosh and suspected hepatotoxicity-inconsistencies, confounding variables, and prospective use of a diagnostic causality algorithm: A critical review. Menopause 2010; 17: 426-40.
    • (2010) Menopause , vol.17 , pp. 426-440
    • Teschke, R.1
  • 43
    • 78751566523 scopus 로고    scopus 로고
    • Regulatory causality evaluation methods applied in kava hepatotoxicity: Are they appropriate?
    • Teschke R, Wolff A. Regulatory causality evaluation methods applied in kava hepatotoxicity: Are they appropriate? Regul Toxicol Pharmacol 2011; 59: 1-7.
    • (2011) Regul Toxicol Pharmacol , vol.59 , pp. 1-7
    • Teschke, R.1    Wolff, A.2
  • 44
    • 84856692080 scopus 로고    scopus 로고
    • WHO, WHO Collaboratoring Centre for International Drug Monitoring (Uppsala Monitoring Centre, UMC), Database. Available at, [Accessed February 20, 2012]
    • WHO. Causality assessment of suspected adverse reactions. WHO Collaboratoring Centre for International Drug Monitoring (Uppsala Monitoring Centre, UMC), Database. Available at: www.who-umc.org/DynPage.aspx?id=22682 [Accessed February 20, 2012].
    • Causality Assessment of Suspected Adverse Reactions


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.