Date: 2014-07-16 The State Food and Drug Administration (SFDA) released the 61st Adverse Drug Reaction (ADR) Information Bulletin, suggesting that oral administration of Radix Polygoni Multiflori (Radix Polygoni Multiflori) and its prescription preparations may have the risk of causing liver injury. The National Adverse Drug Reaction Case Report Database has received case reports of liver injury caused by oral administration of Radix Polygoni Multiflori (RPE) and its prescription preparations. After analyzing the relevant cases and combining them with the relevant literature, it is believed that oral administration of Radix Polygoni Multiflori (RPE) and its prescription preparations has a certain degree of relevance to the occurrence of liver injury. He Shou Wu is divided into raw He Shou Wu and prepared He Shou Wu. Case reports indicate that the risk of hepatic injury is lower in Prepared He Shou Wu than in Raw He Shou Wu. At present, no case report of liver injury caused by topical use of Radix Polygoni Multiflori has been collected. Radix Polygoni Multiflori is a commonly used Chinese herbal medicine and is widely used in medical and health care. Liver injury caused by oral administration of Radix Polygoni Multiflori and its formulas is mostly reversible, and the prognosis is good after stopping the drug or symptomatic treatment. However, overdose and long-term continuous use of the drug may increase its risk. The State Food and Drug Administration reminds: First, medical personnel in the use of He Shouwu and its preparations, should fully understand the risks of its use, detailed understanding of the patient’s history of disease and history of medication, pay attention to the dosage and duration of treatment, to avoid the simultaneous use of other drugs that can lead to liver injury, for patients with hepatic insufficiency, should be avoided to use He Shouwu and its preparations. Second, before using He Shouwu and its preparations, patients should read the instructions carefully and take the medication strictly according to the instructions, or under the guidance of a doctor, to avoid long-term use of the drug. If abnormal liver biochemistry indexes or suspected adverse reactions are found during drug administration, patients should stop taking the drug immediately and seek medical advice. In order to reduce the risk of medication and protect public health, the State Food and Drug Administration has organized the revision of the instructions of the higher-risk varieties of formula preparations containing He Shouwu, such as Nourishing Blood and Hair Capsules, Shouwu Pills (tablets), Shouwu Yanshou Tablets (granules), and Baike Pills, and has added relevant safety information. Other relevant drug manufacturers should be in accordance with the “Drug Description and Labeling Regulations” (State Food and Drug Administration Decree No. 24) requirements, according to the actual varieties and the monitoring of adverse reactions to improve the safety information in the instructions, suggesting the risk of medication. The State Food and Drug Administration has also taken relevant measures for health food containing He Shouwu: First, the daily dosage of raw He Shouwu and systematic He Shouwu in health food. The second is to require the health food containing He Shouwu, labeling and identification of unsuitable people to add “liver insufficiency, family history of liver disease”, add “this product contains He Shouwu, should not be taken for a long time in excess of the amount of avoid concurrent use with hepatotoxicity, pay attention to the monitoring of liver function. “. Thirdly, health food manufacturers are required to strengthen the management of raw materials to ensure that the technical requirements of the raw materials used in He Shouwu are in line with the relevant provisions of the Pharmacopoeia of the People’s Republic of China, and to strengthen the safety monitoring of He Shouwu-containing health food products on the market to find out the safety hazards of taking measures in a timely manner, to effectively safeguard the safety of consumption by consumers. Fourth, the provinces (municipalities, districts) Food and Drug Administration to increase supervision and inspection efforts to strengthen the supervision and guidance of the relevant enterprises. Fifth, to further strengthen the health food containing He Shouwu safety review. The State Food and Drug Administration is actively organizing relevant organizations to explore and study the ingredients, dosage, mechanism, etc. of liver injury caused by Radix Polygoni Multiflori, with a view to adopting more effective measures to safeguard the public’s dietary safety.