Background: Herb-induced liver injuries are rare and often lack careful evaluation by physicians and regulatory agencies, with the consequence that alternative diseases with specific therapeutic modalities are missed. Other shortcomings are low data quality that additionally complicates adequate evaluation.
Methods: Based on our own experience and a selective literature search, recommendations are presented that will substantially improve data acquisition and causality evaluation.
Results: Important diagnostic criteria include clinical manifestation, dechallenge, type of liver injury, (unintentional) reexposure, comedication, risk factors, primary disease, and definitive exclusion of alternative causes. Concomitantly, the data quality in cases of primarily assumed herbal hepatotoxicity may be substantially improved merely by strict data acquisition using a liver specific form. To establish the diagnosis of hepatic adverse drug reaction, a liver specific causality assessment method is available, which has been proven valuable for physicians and regulatory agencies for pharmacovigilance issues, and should be used more often. Using additional diagnostic steps, care should be taken that alternative diseases are recognized in time and treated adequately.
Conclusion: In hospital and outpatient settings, primarily assumed herb-induced liver injury is a particular challenge for physicians and regulatory agencies that requires substantially improved case data quality and causality evaluation.
© Georg Thieme Verlag KG Stuttgart · New York.