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Dieter Melchart, Stefan Hager, Jingzhang Dai, Wolfgang Weidenhammer
BACKGROUND: The use of drugs derived from plants is a cornerstone of Traditional Chinese Medicine (TCM). Yet, too little is known about risk and safety of Chinese medicinal drugs (CMD). Therefore, the TCM hospital Bad Kötzting has developed a quality control and complication screening programme in order to ensure a safe administration of TCM drugs to their patients. METHODS: All Chinese medicinal drugs delivered to the hospital between September 1, 2012 and December 31, 2013 entered the quality control program and were screened for microbial contamination, aflatoxin, pesticides and heavy metals...
2016: Forschende Komplementärmedizin, Research in Complementary Medicine
Gaby Danan, Rolf Teschke
RUCAM (Roussel Uclaf Causality Assessment Method) or its previous synonym CIOMS (Council for International Organizations of Medical Sciences) is a well established tool in common use to quantitatively assess causality in cases of suspected drug induced liver injury (DILI) and herb induced liver injury (HILI). Historical background and the original work confirm the use of RUCAM as single term for future cases, dismissing now the term CIOMS for reasons of simplicity and clarity. RUCAM represents a structured, standardized, validated, and hepatotoxicity specific diagnostic approach that attributes scores to individual key items, providing final quantitative gradings of causality for each suspect drug/herb in a case report...
2016: International Journal of Molecular Sciences
Rolf Teschke, Alexander Schwarzenboeck, Christian Frenzel, Johannes Schulze, Axel Eickhoff, Albrecht Wolff
BACKGROUND AND AIM: In the fall of 2013, the US Centers for Disease Control and Prevention (CDC) published a preliminary report on a cluster of liver disease cases that emerged in Hawaii in the summer 2013. This report claimed a temporal association as sufficient evidence that OxyELITE Pro (OEP), a dietary supplement (DS) mainly for weight loss, was the cause of this mysterious cluster. However, the presented data were inconsistent and required a thorough reanalysis. MATERIAL AND METHODS: To further investigate the cause(s) of this cluster, we critically evaluated redacted raw clinical data of the cluster patients, as the CDC report received tremendous publicity in local and nationwide newspapers and television...
January 2016: Annals of Hepatology
Hong Jung Woo, Ha Yeon Kim, Eun Sol Choi, Young-Hwan Cho, Youngchul Kim, Jang-Hoon Lee, Eungyeong Jang
BACKGROUND: Although herbal medicines (HMs) are widely used in Asian and Western countries, medicinal information concerning their hepatic toxicity or interaction with conventional medicines (CMs) is sparse. PURPOSE: The aim of our study was to estimate the prevalence of drug-induced liver injury (DILI) among total inpatients prescribed HMs or CMs. Furthermore, we noted all medications suspected to be associated with hepatotoxicity in the liver injury group during the period of hospitalization...
December 1, 2015: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
Rolf Teschke
Traditional Chinese Medicine (TCM) is popular around the world and encompasses many different practices with particular emphasis on herbal TCM. Using the PubMed database, a literature search was undertaken to assess the extent herbal TCM products exert rare hepatotoxicity. Analysis of reported cases revealed numerous specified herbal TCM products with potential hepatotoxicity. Among these were An Shu Ling, Bai Fang, Bai Xian Pi, Ban Tu Wan, Bo He, Bo Ye Qing Niu Dan, Bofu Tsu Sho San, Boh Gol Zhee, Cang Er Zi, Chai Hu, Chaso, Chi R Yun, Chuan Lian Zi, Ci Wu Jia, Da Chai Hu Tang, Da Huang, Du Huo, Gan Cao, Ge Gen, Ho Shou Wu, Hu Bohe You, Hu Zhang, Huang Qin, Huang Yao Zi, Hwang Geun Cho, Ji Gu Cao, Ji Ji, Ji Xue Cao, Jiguja, Jin Bu Huan, Jue Ming Zi, Kamishoyosan, Kudzu, Lei Gong Teng, Long Dan Xie Gan Tang, Lu Cha, Ma Huang, Mao Guo Tian Jie Cai, Onshido, Polygonum multiflorum, Qian Li Guang, Ren Shen, Sairei To, Shan Chi, Shen Min, Shi Can, Shi Liu Pi, Shou Wu Pian, Tian Hua Fen, White flood, Wu Bei Zi, Xi Shu, Xiao Chai Hu Tang, Yin Chen Hao, Zexie, Zhen Chu Cao, and various unclassified Chinese herbal mixtures...
June 2014: Journal of Clinical and Translational Hepatology
Rolf Teschke, Axel Eickhoff, Johannes Schulze
Drug-induced liver injury (DILI) and herb-induced liver injury (HILI) are typical diseases of clinical and translational hepatology. Their diagnosis is complex and requires an experienced clinician to translate basic science into clinical judgment and identify a valid causality algorithm. To prospectively assess causality starting on the day DILI or HILI is suspected, the best approach for physicians is to use the Council for International Organizations of Medical Sciences (CIOMS) scale in its original or preferably its updated version...
September 2013: Journal of Clinical and Translational Hepatology
Hadi Harati, Maziar Rahmani, Sassan Taghizadeh
Hydralazine is a commonly used oral antihypertensive agent. We report a rare case of hydralazine-induced hepatotoxicity in the form of subacute hepatic necrosis. A 75-year-old African American woman presented with jaundice of 7-day duration. She was started on hydralazine 100 mg 3 times a day 10 weeks before presentation. On physical examination, scleral icterus was noted. Workup revealed elevated liver transaminases, alkaline phosphatase, and conjugated bilirubin. She had no history of liver disease, and liver function tests had been normal before starting hydralazine...
September 2016: American Journal of Therapeutics
Akiyoshi Shinohara, Masato Nakamura, Toshihide Onikubo, Kumi Nakamura
Chemotherapy-induced oral mucositis (CIOM) is a severe adverse event resulting from cancer chemotherapy. Toxic free radicals and pro-inflammatory cytokines produced by anticancer drugs have been reported to be associated with CIOM. Rebamipide has been shown to increase gastric endogenous prostaglandin E2 and I2, to promote gastric epithelial mucin, and to behave as an oxygen free-radical scavenger in addition to other anti-inflammatory actions. We developed a gargle solution of rebamipide, adding ultrahydrogel for mucosal protection and to maintain rebamipide on the oral mucosa...
2015: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
Tauqeer Ahmed, Ritwik Pandey, Bhavini Shah, Jason Black
We describe a case of a patient from Far North Queensland, Australia, with life-threatening hepatotoxicity caused by ipilimumab induced immune-related adverse events (irAEs). Our patient presented with non-specific symptoms including malaise, lethargy and fevers. Her work up revealed acute hepatitis, which was presumed to be related to ipilimumab treatment for her metastatic melanoma. Causality for ipilimumab was assessed with the CIOMS scale (Council for International Organizations of Medical Sciences) and provided a causality level of 'highly probable' (score +9)...
2015: BMJ Case Reports
Gabriela Mazzanti, Antonella Di Sotto, Annabella Vitalone
Green tea (GT), obtained from the leaves of Camellia sinensis (L.) Kuntze (Fam. Theaceae), is largely used for its potential health benefits such as reduction in risk of cardiovascular diseases and weight loss. Nevertheless, it is suspected to induce liver damage. Present work reviews the hepatic adverse reactions associated with GT-based herbal supplements, published by the end of 2008 to March 2015. A systematic research was carried out on PubMed, MedlinePlus, Scopus and Google Scholar databases, without any language restriction...
August 2015: Archives of Toxicology
Rolf Teschke, Axel Eickhoff
Plants are natural producers of chemical substances, providing potential treatment of human ailments since ancient times. Some herbal chemicals in medicinal plants of traditional and modern medicine carry the risk of herb induced liver injury (HILI) with a severe or potentially lethal clinical course, and the requirement of a liver transplant. Discontinuation of herbal use is mandatory in time when HILI is first suspected as diagnosis. Although, herbal hepatotoxicity is of utmost clinical and regulatory importance, lack of a stringent causality assessment remains a major issue for patients with suspected HILI, while this problem is best overcome by the use of the hepatotoxicity specific CIOMS (Council for International Organizations of Medical Sciences) scale and the evaluation of unintentional reexposure test results...
2015: Frontiers in Pharmacology
Edgardo Mengual-Moreno, Maribel Lizarzábal-García, María Ruiz-Soler, Niniveth Silva-Suarez, Raúl Andrade-Bellido, Maribel Lucena-González, Fernando Bessone, Nelia Hernández, Adriana Sánchez, Inmaculada Medina-Cáliz
Drug-induced liver injury (DILI) is an important cause of morbidity and mortality worldwide, with varied geographical differences. The aim of this prospective, descriptive, cross-sectional study was to identify and characterize cases of DILI in a hospital of Zulia state, Venezuela. Thirteen patients with a presumptive diagnosis of DILI attended by the Department of Gastroenterology, Hospital Universitario, Zulia state, Venezuela, from December-2012 to December-2013 were studied. Ibuprofen (n = 3; 23.1%), acetaminophen (n = 3; 23...
March 2015: Investigación Clínica
Hoi Y Tong, Carmen Díaz, Elena Collantes, Nicolás Medrano, Alberto M Borobia, Paloma Jara, Elena Ramírez
Background. Methylphenidate (MPH) is widely used in treating children with attention-deficit-hyperactivity disorder. Hepatotoxicity is a rare phenomenon; only few cases are described with no liver failure. Case. We report on the case of a 12-year-old boy who received MPH for attention-deficit-hyperactivity disorder. Two months later the patient presented with signs and symptoms of hepatitis and MPH was discontinued, showing progressive worsening and developing liver failure and a liver transplantation was required...
2015: Case Reports in Pediatrics
Noni E MacDonald, Stephane Guichard, Ananda Amarasinghe, Madhava Ram Balakrishnan
BACKGROUND: Poorly managed AEFI undermine immunization programs. Improved surveillance in SEAR countries means more AEFIs but management varies. SEAR brought countries together to share AEFI experiences, and learn more about causality assessment. METHODS: Three day 10 country workshop (9 SEAR; 1 WPR). Participants outlined county AEFI experiences, undertook causality assessment for 8 AEFIs using WHO methodology, critiqued the process by questionnaire and had a discussion...
November 27, 2015: Vaccine
Rolf Teschke, Li Zhang, Hongzhu Long, Alexander Schwarzenboeck, Wolfgang Schmidt-Taenzer, Alexander Genthner, Albrecht Wolff, Christian Frenzel, Johannes Schulze, Axel Eickhoff
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...
January 2015: Annals of Hepatology
Roxanne Lim, Hassan Choudry, Kim Conner, Wikrom Karnsakul
Drug-induced hepatotoxicity most commonly manifests as an acute hepatitis syndrome and remains the leading cause of drug-induced death/mortality and the primary reason for withdrawal of drugs from the pharmaceutical market. We report a case of acute liver injury in a 12-year-old Hispanic boy, who received a series of five antibiotics (amoxicillin, ceftriaxone, vancomycin, ampicillin/sulbactam, and clindamycin) for cervical lymphadenitis/retropharyngeal cellulitis. Histopathology of the liver biopsy specimen revealed acute cholestatic hepatitis...
2014: Case Reports in Pediatrics
Antonios Douros, Elisabeth Bronder, Frank Andersohn, Andreas Klimpel, Michael Thomae, Giselle Sarganas, Reinhold Kreutz, Edeltraut Garbe
AIM: Drug-induced liver injury (DILI) is often responsible for acute liver failure, drug withdrawal, boxed warnings or drug non-approval. Therefore, we conducted a case-control study to determine the hepatotoxic risk of a wide range of drugs. METHODS: The Berlin Case-Control Surveillance Study FAKOS included all 51 Berlin hospitals in a hospital network. Between 2002 and 2011, 198 patients with acute idiopathic hepatitis, 377 inpatient controls and 708 outpatient controls were ascertained...
June 2015: British Journal of Clinical Pharmacology
David Ríos, Juan C Restrepo
We report a case of a 47-year-old male, who was referred to the clinical hepatology services at Pablo Tobón Uribe Hospital for evaluation of a jaundice syndrome. After undergoing several exams, we diagnosed hepatic hydatidosis and the patient was treated with albendazole; however, after five months of uninterrupted treatment the patient again consulted and his liver test showed marked hepatocellular damage. This time, the patient was diagnosed with drug-induced liver injury due to albendazole, based on information from the clinical record, history of drug consumption, clinical and laboratory tests improved after discontinuing the medication and after discarding other possible causes; this diagnosis was supported by the CIOMS/RUCAM scale, which showed a "likely" correlation between hepatocellular damage and drug toxicity etiology...
April 2013: Colombia Médica: CM
Folke Sjöqvist
This MiniReview shows that both WHO and IUPHAR very early recognized that there is a gap between the availability of academic expert knowledge in pharmacology and its utilization in health care. Many initiatives have been taken to bridge this gap, but still 12 European countries do not recognize clinical pharmacology as a medical speciality because the profession has failed to develop defined functions in patient care. A first priority for EACPT therefore ought to be to promote clinical pharmacology as a medical speciality recognized by the European Union...
August 2014: Basic & Clinical Pharmacology & Toxicology
Mike H Pillukat, Carolin Bester, Andreas Hensel, Matthias Lechtenberg, Frank Petereit, Susanne Beckebaum, Klaus-Michael Müller, Hartmut H J Schmidt
UNLABELLED: ETNOPHARMACOLOGICAL RELEVANCE: The popularity of concentrated green tea extracts as dietary supplements for a wide range of applications is increasing due to their health-promoting effects attributed to the high amounts of catechins they contain. The most important of the green tea catechins is (-)-epigallocatechin-3-O-gallate (EGCG). While their beneficiary effects have been studied extensively, a small number of adverse events have been reported in the medical literature...
August 8, 2014: Journal of Ethnopharmacology
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