Hepatic side effects, idiosyncratic or toxic mechanisms – differentiated evaluation for regulatory affairs for herbal remedies

In the last decade also for herbal remedies side effects and interactions with other remedies are reported. Unfortunately these observations by herbal remedies are evaluated often without a necessary differentiation by a general prescription of the drug. On three recent occasions in Germany drug regulatory, decisions for herbal drugs (Meliloti herba, Piperis methystici rhizoma, Chelidonii herba) have been based on possible hepatotoxicity as suspected adverse effects. These decisions have been contested on the ground that adverse effect attributions have not been based on scientific evidence but mainly on animal…