a-t 2015; 46: 31

Liver damage due to IBEROGAST? A 51-year old woman tried to treat her nausea with IBEROGAST, a mixture of herbal extracts. About two weeks after having taken the drops once, she presented with a deterioration in general health, weight loss and jaundice at the hospital and was diagnosed with hepatitis and cell necrosis in a liver biopsy specimen. Following the exclusion of other potential causes, the condition is assumed to be the result of drug toxicity caused by the greater celandine tincture contained in the phytopharmaceutical product (NETWORK report 16.721). Greater celandine is known to be hepatotoxic (a-t 1997; no. 11: 118). However, we do not know of any previous case of liver damage after taking just one dose in the literature. In the cases described, hepatotoxicity manifests after several weeks to months and generally improves following discontinuation of the drug (1-3). The association is not uncommonly only identified after other potential causes have been excluded when patients are directly asked whether they had taken any herbal products (4). This means that a considerable number of unidentified cases might be expected. In 2008 the Federal Institute for Drugs and Medical Devices (BfArM) banned preparations with a total daily dose of more than 2.5 mg of total alkaloids calculated as chelidonine and directed that the label information of preparations with a daily dose of 2.5 µg to 2.5 mg like IBEROGAST has to contain information about the potential for liver damage (5). Steigerwald appealed against this decision (6) and did not adapt the package leaflet or its heavy advertising for its bestseller*. After nearly seven years, the appeal proceedings have still not been concluded. According to the European Medicines Agency EMA greater celandine has a negative benefit-risk ratio even in daily doses of less than 2.5 mg of total alkaloids (7). We recommend against the use of IBEROGAST -Ed.

1LiverTox Database: http://livertox.nlm.nih.gov/GreaterCelandin.htm
2TESCHKE, R. et al.: Regul. Toxicol. Pharmacol. 2011; 61: 282-91
3TESCHKE, R. et al.: Eur. J. Gastroenterol. Hepatol. 2012; 24: 270-80
4BENNINGER, J. et al.: Gastroenterology 1999; 117:1234-7
5BfArM: Schöllkraut-haltige Arzneimittel zur innerlichen Anwendung, Stufenplanbescheid vom 9. Apr. 2008; http://www.a-turl.de/?k=uxte
6Steigerwald: letter dated 3 March 2015
7EMA: Assessment Report on Chelidonium majus, herba, as at 2011 http://www.a-turl.de/?k=rivi

*In 2013, nearly 9 million packages of IBEROGAST with a value of around 56.5 million Euro (based on ex-factory prices) were sold.

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