[Evaluation and consideration on safety information abroad of Polygonum multiflorum and its preparations].
This article retrospectively analyzed the safety reports published abroad regarding Polygonum multiflorum and its preparations in terms of drug use and liver damage. The authors found that the foreign drug regulatory authorities are lack of in-depth analysis and investigation on the safety information of P. multiflorum and its preparations in the process of reporting and warning. Therefore, the authors consider the following factors are significant for scientific evaluation of traditional Chinese medicine (TCM) safety: follow-up and investigation of the information based on literature study, establishment of the safety-related information communication and feedback mechanism with foreign drug regulatory authorities and drafting of the guidelines for rational use of TCM.
Zhang
Li
L
National Centerf or Drug Reevaluation, State Food and Drug Administration, Beijing 100045, Chnia. yty0616@hotmail.com
Yang
Xiaohui
X
Deng
Yuanyuan
Y
D000818:Animals; D001315:Australia; D002170:Canada; D004341:Drug Evaluation / Q000331:legislation & jurisprudence / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000592:standards / Q000633:toxicity*; D004739:England; D006801:Humans; D007880:Legislation, Drug / Q000592:standards; D008099:Liver / Q000187:drug effects; D028502:Polygonum / Q000737:chemistry*
D004365:Drugs, Chinese Herbal