Japan - Three cases of hepatic dysfunction have been reported during treatment with the over-the-counter product Seirogan®, which contains glycyrrhizin, creosote, gambir, phellodendron bark and citrus unshiu peel. The product is indicated for the treatment of diarrhoea, vomiting, and food poisoning. The Ministry of Health, Labour and Welfare (MHLW) have responded by calling for hepatic dysfunction to be added to the product label; the paragraph ‘The patient should consult a physician in the following cases’, will describe hepatic dysfunction as a serious adverse event that may rarely occur.
Reference: MHLW Pharmaceuticals and Medical Devices Safety Information. ADR updates from Japan. Media Release, March 2001