Center for Drug Reevaluation

Beijing, China

Center for Drug Reevaluation

Beijing, China
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Song H.-B.,Center for Drug Reevaluation | Han L.,Center for Drug Evaluation
Chinese Journal of Pharmacology and Toxicology | Year: 2016

There have been increasing reports on liver injury induced by traditional Chinese medicine (TCM) and natural medicine in recent years. The risk of liver injury induced by TCMs has attracted more attention at home and abroad. In this paper, epidemiologic characteristics, risk factors, clinical features of TCMs induced liver injury were discussed. The myth about research and safety evaluation of TCMs induced liver injury was analyzed. Based on the property of TCMs and characteristics of their clinical use, this paper proposed the priorities of basic and clinical safety evaluation of TCMs induced liver toxicity. It is hoped that this study may provide reference for scientific evaluation of liver toxicity of TCMs.

Xia D.-S.,Center for Drug Reevaluation
Chinese Pharmaceutical Journal | Year: 2014

OBJECTIVE: To improve the worlds understanding about Chinese evaluation system of nonprescription medicines; to help Chinese pharmaceutical enterprises know more about nonprescription and the procedures of application; to promote relevant departments to make contributions to the development of evaluation system on nonprescription medicines and the establishment of the frame of the responsible self-medication for the public. METHODS: Based on the related Chinese regulations and policies, the establishment and development of Chinese evaluation system on nonprescription medicines is elaborated, and problems are proposed and the further development is suggested. RESULTS: Although Chinese evaluation system on nonprescription medicines has been established and made great progress, further exploratory is needed. CONCLUSION: Themanagement on drug classification and the research on technical evaluation of nonprescription medicines needs to be strengthened, which has a broad prospect in the future.

Teschke R.,Goethe University Frankfurt | Zhang L.,Center for Drug Reevaluation | Melzer L.,Goethe University Frankfurt | Schulze J.,Goethe University Frankfurt | Eickhoff A.,Goethe University Frankfurt
Expert Opinion on Drug Metabolism and Toxicology | Year: 2014

Introduction: Catechins of green tea extract (GTE) have been associated with the rare risk of hepatotoxicity in a few individuals. As GTE were coadministered with synthetic drugs in some hepatotoxicity cases, uncertainty emerged whether GTE are a risk factor of drug-induced liver injury (DILI).Areas covered: Case reports of liver injury by GTE and related review articles to assess the drugs that were coadministered with GTE were reviewed. The analysis included the question whether a formal causality of liver injury had confidently been attributed to GTE, the comedicated drug(s) or both. To elucidate possible metabolic interactions, GTE and their catechins were analyzed regarding their affinity to various CYP isoforms.Expert opinion: The authors conclude that the published hepatotoxicity case reports in connection with the use of GTE provide no clinical evidence that GTE may increase the risk of DILI by drugs that had been comedicated in only few cases. Although partial inhibition of human hepatic and intestinal microsomal CYP2C8, CYP2B6, CYP3A4, CYP2D6 and CYP2C19 by GTE catechins was observed in vitro, a clinical study of drug bioavailability attributed a small risk of increased plasma drug levels only for substrates metabolized by CYP3A4, lacking clinical relevance. © 2014 Informa UK, Ltd.

Teschke R.,Goethe University Frankfurt | Zhang L.,Center for Drug Reevaluation | Long H.,Beijing University of Chinese Medicine | Schwarzenboeck A.,Goethe University Frankfurt | And 6 more authors.
Annals of Hepatology | Year: 2015

Traditional Chinese Medicine (TCM) with its focus on herbal use became popular worldwide. Treatment was perceived as safe, with neglect of rare adverse reactions including liver injury. To compile worldwide cases of liver injury by herbal TCM, we undertook a selective literature search in the PubMed database and searched for the items Traditional Chinese Medicine, TCM, Traditional Asian Medicine, and Traditional Oriental Medicine, also combined with the terms herbal hepatotoxicity or herb induced liver injury. The search focused primarily on English-language case reports, case series, and clinical reviews. We identified reported hepatotoxicity cases in 77 relevant publications with 57 different herbs and herbal mixtures of TCM, which were further analyzed for causality by the Council for International Organizations of Medical Sciences (CIOMS) scale, positive reexposure test results, or both. Causality was established for 28/57 different herbs or herbal mixtures, Bai Xian Pi, Bo He, Ci Wu Jia, Chuan Lian Zi, Da Huang, Gan Cao, Ge Gen, Ho Shou Wu, Huang Qin, Hwang Geun Cho, Ji Gu Cao, Ji Xue Cao, Jin Bu Huan, Jue Ming Zi, Jiguja, Kudzu, Ling Yang Qing Fei Keli, Lu Cha, Rhen Shen, Ma Huang, Shou Wu Pian, Shan Chi, Shen Min, Syo Saiko To, Xiao Chai Hu Tang, Yin Chen Hao, Zexie, and Zhen Chu Cao. In conclusion, this compilation of liver injury cases establishes causality for 28/57 different TCM herbs and herbal mixtures, aiding diagnosis for physicians who care for patients with liver disease possibly related to herbal TCM. © 2014 Annals of Hepatology. All rights reserved.

Zhang L.,Center for Drug Reevaluation | Wong L.Y.L.,University of Hong Kong | He Y.,University of Hong Kong | Wong I.C.K.,University of Hong Kong
Drug Safety | Year: 2014

With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging ‘manufacturer communication meetings’, modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed. © 2014, Springer International Publishing Switzerland.

Wang J.-B.,302 Military Hospital | Xiao X.-H.,302 Military Hospital | Du X.-X.,Center for Drug Reevaluation | Zou Z.-S.,302 Military Hospital | And 2 more authors.
Zhongguo Zhongyao Zazhi | Year: 2014

Recently traditional Chinese medicine (TCM)-induced liver injury has been an unresolved critical issue which impacts TCM clinical safety. The premise and key step to reduce or avoid drug-induced liver injury (DILI) is to identify the drug source of liver injury in early stage. Then the timely withdrawal of drug and treatment can be done. However, the current diagnosis of DILI is primarily governed by exclusive method relying on administering history supplied by patients and experience judgment from doctors, which lacks objective and reliable diagnostic indices. It is obvious that diagnosis of TCM-induced liver injury is especially difficult due to the complicated composition of TCM medication, as well the frequent combination of Chinese and Western drugs in clinic. In this paper, we proposed construction of research pattern and method for objective identification of TCM-related DILI based on translational toxicology, which utilizes clinical specimen to find specific biomarkers and characteristic blood-entering constituents, as well the clinical biochemistry and liver biopsy. With integration of diagnosis marker database, bibliographic database, medical record database and clinical specimen database, an integrative diagnosis database for TCM-related DILI can be established, which would make a transformation of clinical identification pattern for TCM-induced liver injury from subjective and exclusive to objective and index-supporting mode. This would be helpful to improve rational uses of TCM and promote sustainable development of TCM industry.

PubMed | 302 Military Hospital and Center for Drug Reevaluation
Type: Journal Article | Journal: Journal of gastroenterology and hepatology | Year: 2016

Chinese herbal medicine (CHM), as well as Western medicine (WM), is an important cause of drug-induced liver injury (DILI). However, the differences between CHM and WM as agents implicated in liver injury have rarely been reported.Overall, 1985 (2.05%) DILI cases were retrospectively collected from the 96857 patients hospitalized because of liver dysfunction in the 302 Military Hospital between January 2009 and January 2014.In all the enrolled patients with DILI, CHM was implicated in 563 cases (28.4%), while 870 cases (43.8%) were caused by WM and the remaining patients (27.8%) by the combination of WM and CHM. Polygonum multiflorum was the major implicated CHM. Compared with WM, the cases caused by CHM showed more female (51 vs 71%, P<0.001) and positive rechallenge (6.1 vs 8.9%, P=0.046), a much greater proportion of hepatocellular injury (62.2 vs 88.5%, P<0.001), and a higher mortality (2.8 vs 4.8%, P=0.042); however, no differences in the rates of chronic DILI and ALF were found (12.9 vs 12.4%, P=0.807; 7.6 vs 7.6%, P=0.971). Based on Roussel Uclaf Causality Assessment Method, 75.6% of cases caused by CHM were classified as probable and only 16.6% as highly probable, significantly different from WM (38.4 and 60.3%, all P<0.001).The causal relationship between CHM and liver injury is much complex, and the clinical characteristics of DILI caused by CHM differ from those caused by WM.

Zhang L.,Center for Drug Reevaluation | Yan J.,Beijing University of Chinese Medicine | Liu X.,Chinese Academy of Sciences | Ye Z.,Chinese Academy of Sciences | And 6 more authors.
Journal of Ethnopharmacology | Year: 2012

Ethnopharmacological relevance: Traditional Chinese Medicine (TCM), including Traditional Chinese Medicine drugs (TCM drugs), has been playing a very important role in health protection and disease control for thousands of years in China. Relying on natural products, mainly of herbal origin, used either as raw materials for decoction, as prepared herbal medicines or as formulated traditional medicines, TCM is still widely accepted by Chinese people, especially for chronic diseases treatment. This extensive use warrants safety measures and so TCM drug safety monitoring and risk management are becoming increasingly important tasks for the Chinese State Food and Drug Administration (SFDA). Methods: The Adverse Drug Reaction (ADR) monitoring system in China was established both for western and TCM drugs in 1989 as a voluntary reporting system with a National Center collecting and compiling reports. Serious or multi-case reports on individual TCM drug or formulated products are detailed in the Chinese ADR Information Bulletin to inform the public and Drug Administrative authorities for risk management. Results: About 10-15% of the ADR reports received by the National Center are related to TCM drugs and mainly pertaining to the formulated products. In certain cases, the suspension of a particular TCM preparation is decided by SFDA China. Conclusion: The model of safety monitoring and risk management of TCM drugs is still under exploration. Indeed, the characteristics and risk factors associated with these drugs require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, exploration of the actives monitoring methodology and enhancement of international communication and cooperation. © 2012 Elsevier Ireland Ltd. All rights reserved.

Ren Y.,Chinese Institute of Materia Medica | Ren Y.,Chengdu University of Traditional Chinese Medicine | Zhang P.,Chinese Institute of Materia Medica | Yan D.,Chinese Institute of Materia Medica | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2011

Herbal injections are powerful preparations of traditional Chinese medicines. However, the quality control (QC) of these formulations is difficult to establish. Recently, chemical fingerprinting (CF) has been recommended as a potential strategy for the QC of herbal injections. However, some constituents cannot be detected by chromatographic methods. To establish a comprehensive QC process, biological fingerprinting (BF) was combined with CF to detect the fluctuation in quality of a herbal injection from chemical and biological aspects. Yinzhihuang injection was selected as a representative herbal injection. Ten batches of normal samples and six batches of artificially abnormal samples were collected. High-performance liquid chromatography and thermal activity monitoring were applied to develop CF and BF, respectively. The CF and BF of normal samples were similar, with good stability and consistency, but the abnormal samples were not. The results were analyzed by hierarchical clustering analysis: all abnormal samples could be correctly distinguished when CF and BF were combined. The recognition ratio was higher for CF (87.5%) than for BF (93.75%). The key factors of quality fluctuation were bacterial contamination, high temperature, lighting, and sterilizing conditions. The described method could be used for early prediction of adverse drug events, which could help improve the safety of herbal injections. © 2011 Elsevier B.V.

Xia D.-S.,Center for Drug Reevaluation
Chinese Traditional and Herbal Drugs | Year: 2011

The toxicity of Chinese materia medica (CMM) is one of cores of the property theory of CMM. From the perspective of history, the literature source of the understanding on CMM toxicity was traced; The traditional and contemporary understanding about the meaning and classification of CMM toxicity was compared and analyzed; The ideas on CMM toxicity with the feature of tradition, experience, objectivity, the integrity of the concept, and some of the controllability were proposed; The theory and practice of traditional Chinese medicines should be combined in order to effectively integrate and apply various modern scientific and technical methods, and create new ideas about toxicity studies of CMM, which has the important significance on the comprehensive understanding about CMM toxicity, strengthening the research on CMM toxicity, and promoting the safety of CMM in clinical use.

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