Pharmacovigilance and herbal hepatotoxicity: Critical aspects and solutions;Pharmakovigilanz und herbale Hepatotoxizität: kritische Aspekte und Lösungswege

Deutsche Medizinische Wochenschrift

Volumn 138, Issue 6, 2013, Pages 281-284

  Teschke, R ^a   Schulze, J ^a  

^a GOETHE UNIVERSITY   (Germany)

Author keywords

causality assessment; hepatotoxicity; herbal drugs; herbal supplements; liver diseases; phytopharmaceuticals

Indexed keywords

DRUG SURVEILLANCE PROGRAM; HERBAL MEDICINE; LIVER TOXICITY; NOTE;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CAUSALITY; DIETARY SUPPLEMENTS; DRUG-INDUCED LIVER INJURY; GERMANY; HUMANS; PHARMACOVIGILANCE; PHYTOTHERAPY; PLANT EXTRACTS; PLANTS, MEDICINAL;

EID: 84872894333     PISSN: 00120472     EISSN: 14394413     Source Type: Journal    
DOI: 10.1055/s-0032-1332845     Document Type: Note

References (21)

1. Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ) Hepatitis im Zusammenhang mit Umckaloabo® Dtsch Ärztebl: 2011; 108 C1399 C1400
2. 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 1336 (Pubitemid 23333874)
3. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Kausalitätsbeurteilung nach WHO ist adäquat. Dtsch Apoth Ztg: 2012; 152 1766 1769
4. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Pelargoniumhaltige Arzneimittel: Risiko von Leberschädigungen. 28 06 2012; http://www.bfarm.de Letzter Zugriff 9.1.2013
5. 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 1330 (Pubitemid 23333873)
6. Friemel A., Sachs B. Hepatotoxische Reaktionen im Zusammenhang mit der Anwendung von Pelargonium-haltigen Arzneimitteln. Bulletin zur Arzneimittelsicherheit: 01 03 2012; 6 7 www.ebm-netzwerk.de/aktuelles/news2012- 03-26-2 Letzter Zugriff 9.1.2013
7. Licata A., Macaluso F. S., Craxi A. Herbal hepatotoxicity: a hidden epidemic. Intern Emerg Med: 2012; DOI: 10.1007/s11739-012-0777-x
8. Schmidt M., Morgan M., Bone K., McMillan J. Kava: a risk-benefit assessment. In: Mills M., Bone K. Eds. The essential guide to herbal safety. St. Louis (Missouri) Elsevier Churchill Livingstone: 2005; 155 221
9. Schulze J., Raasch W., Siegers C. P. Toxicity of kava pyrones, drug safety and precautions- a case study. Phytomedicine: 2003; 10 04 68 73 (Pubitemid 36597161)
10. Stammschulte T., Gundert-Remy U. Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: Was causality adequately ascertained? Regul Toxicol Pharmacol: 2012; 64 342; author reply 343 344
11. Teschke R. WHO-Kriterien sind nicht für Lebertoxizität validiert. Dtsch Apoth Ztg: 2012; 152 1766 1769
12. Teschke R., Eickhoff A., Wolff A. et al. Herbal hepatotoxicity and WHO global introspection method. Ann Hepatol: 2013; 12 11 21
13. Teschke R., Frenzel C., Schulze J. et al. Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: Was causality adequately ascertained? Regul Toxicol Pharmacol: 2012; 63 1 9
14. Teschke R., Frenzel C., Schulze J. et al. Suspected herbal hepatotoxicity: The pharmacovigilance dilemma with disputed and obsolete evaluation methods. Regul Toxicol Pharmacol: 2012; 64 343 344
15. Teschke R., Frenzel C., Wolff A. et al. Initially purported hepatotoxicity by Pelargonium sidoides: the dilemma of pharmacovigilance and proposals for improvements. Ann Hepatol: 2012; 11 500 512
16. Teschke R., Glass X., Schulze J. Herbal hepatotoxicity by Greater Celandine (Chelidonium majus): Causality assessment of 22 spontaneous reports. Regul Toxicol Pharmacol: 2011; 61 282 291
17. 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 ascertain causality? Pharmacoepidemiol Drug Saf: 2011; 20 567 582
18. Teschke R., Schwarzenboeck A., Hennermann K. H. Kava hepatotoxicity: a clinical survey and critical analysis of 26 suspected cases. Eur J Gastroenterol Hepatol: 2008; 20 1182 1193
19. Teschke R., Schwarzenboeck A., Hennermann K. H. Causality assessment in hepatotoxicity by drugs and dietary supplements. Br J Clin Pharmacol: 2008; 66 758 66
20. Teschke R., Wolff A. Regulatory causality evaluation methods applied in kava hepatotoxicity: Are they appropriate? Regul Toxicol Pharmacol: 2011; 59 1 7
21. Teschke R., Wolff A., Frenzel C. et al. Herbal hepatotoxicity: a tabular compilation of reported cases. Liver Int: 2012; 32 1543 1556