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Rolf Teschke, Gaby Danan
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May 2017: Annals of Hepatology
Rolf Teschke, Johannes Schulze, Axel Eickhoff, Gaby Danan
Drug induced liver injury (DILI) is a potentially serious adverse reaction in a few susceptible individuals under therapy by various drugs. Health care professionals facing DILI are confronted with a wealth of drug-unrelated liver diseases with high incidence and prevalence rates, which can confound the DILI diagnosis. Searching for alternative causes is a key element of RUCAM (Roussel Uclaf Causality Assessment Method) to assess rigorously causality in suspected DILI cases. Diagnostic biomarkers as blood tests would be a great help to clinicians, regulators, and pharmaceutical industry would be more comfortable if, in addition to RUCAM, causality of DILI can be confirmed...
April 11, 2017: International Journal of Molecular Sciences
Gabriela Mazzanti, Paola Angela Moro, Emanuel Raschi, Roberto Da Cas, Francesca Menniti-Ippolito
AIMS: Red yeast rice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs). METHODS: Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions...
April 2017: British Journal of Clinical Pharmacology
C W Chen
Currently, the diagnostic criteria for drug-induced liver injury (DILI) used in the clinical studies and related literature in China are very confusing, making it difficult to compare and extend the use of the results, conclusions, and experience of these studies. Therefore, it is necessary to carefully review the developmental history of diagnostic scales and unify the diagnostic criteria and related knowledge of DILI. Since its publication in 1993, Roussel Uclaf Causality Assessment Method (RUCAM) scale has been widely used to assess the causality between drugs and liver injury, both in DILI studies and decisions on the regulation of drugs which may cause liver injury, in order to provide a useful analytical framework for clinical physicians in the diagnosis of DILI...
November 20, 2016: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
Ren-Jie Lu, Yan Zhang, Feng-Lei Tang, Zhong-Wei Zheng, Zheng-Da Fan, Shan-Mei Zhu, Xian-Feng Qian, Na-Na Liu
Drug-induced liver injury (DILI) is often undiagnosed or misdiagnosed clinically because of diagnostic difficulties caused by lack of laboratory-specific serological markers. In this study, we comprehensively assessed the clinical characteristics, laboratory indices, hepatotoxic drugs, risk factors and outcomes concerning DILI, and explored the similarities in mechanisms between Chinese and Western drug-induced DILI. Patients with a first diagnosis of DILI and a Roussel Uclaf Causality Assessment Method (RUCAM) score >3 points were enrolled for systematic retrospective study...
October 2016: Experimental and Therapeutic Medicine
Peng Zhang, Yongan Ye, Xianzhao Yang, Yuntao Jiao
Background. In recent years, with the popularity of CHM, its hepatotoxicity has also been increasingly noticed. However, there are still veils on causative herbs and clinical characteristics. Aim. To systematically review data on CHM induced liver injury with particular focus on causative herbs and clinical characteristics. Methods. Using terms related to CHM and liver injury, PubMed and three Chinese electronic databases were searched, which was limited to the past 5 years. Publications meeting our eligibility criteria were included and further analyzed...
2016: Evidence-based Complementary and Alternative Medicine: ECAM
Christian Frenzel, Rolf Teschke
Herb induced liver injury (HILI) and drug induced liver injury (DILI) share the common characteristic of chemical compounds as their causative agents, which were either produced by the plant or synthetic processes. Both, natural and synthetic chemicals are foreign products to the body and need metabolic degradation to be eliminated. During this process, hepatotoxic metabolites may be generated causing liver injury in susceptible patients. There is uncertainty, whether risk factors such as high lipophilicity or high daily and cumulative doses play a pathogenetic role for HILI, as these are under discussion for DILI...
April 27, 2016: International Journal of Molecular Sciences
Rolf Teschke, Gaby Danan
The relationship between drugs and pre-existing liver disease is complex, particularly when increased liver tests (LTs) or new symptoms emerge in patients with pre-existing liver disease during drug therapy. This requires two strategies to assess whether these changes are due to drug-induced liver injury (DILI) as a new event or due to flares of the underlying liver disease. Lacking a valid diagnostic biomarker, DILI is a diagnosis of exclusion and requires causality assessment by RUCAM, the Roussel Uclaf Causality Assessment Method, to establish an individual causality grading of the suspected drug(s)...
August 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Rolf Teschke, Axel Eickhoff
In 2013, physicians at the Honolulu Queen's Medical Center (QMC) noticed that seven liver disease patients reported the use of OxyELITE Pro (OEP), a widely consumed dietary supplement (DS). Assuming a temporal association between OEP use and disease, they argued that OEP was the cause of this mysterious cluster. Subsequent reexamination, however, has revealed that this QMC cohort is heterogeneous and not a cluster with a single agent causing a single disease. It is heterogeneous because patients used multiple DS's and drugs and because patients appeared to have suffered from multiple liver diseases: liver cirrhosis, liver failure by acetaminophen, hepatotoxicity by non-steroidal antiinflammatory drugs (NSAIDs), resolving acute viral hepatitis by hepatitis B virus (HBV), herpes simplex virus (HSV), and varicella zoster virus (VZV), and suspected hepatitis E virus (HEV)...
March 31, 2016: International Journal of Molecular Sciences
Yun Zhu, Yong-gang Li, Yao Wang, Li-ping Wang, Jia-bo Wang, Rui-lin Wang, Li-fu Wang, Ya-kun Meng, Zhong-xia Wang, He Xiao Xiao
OBJECTIVE: To observe clinical characteristics of herb-induced liver injury (HILI). METHODS: General conditions, medical history, clinical manifestations, biochemical indices, prognosis, and Roussed Uclaf Causality Assessment Method (RUCAM) scores were retrospectively analyzed in 595 inpatients at 302 Military Hospital between January 2009 and January 2014. RESULTS: There were 423 cases (accounting for 71.1%) were females with multiple onset age ranging 41 to 50 years old...
January 2016: Chinese Journal of Integrated Traditional and Western 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...
December 24, 2015: International Journal of Molecular Sciences
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
Lauren Heidemann, James Law, Robert J Fontana
BACKGROUND: Idiosyncratic drug-induced liver injury (DILI) is an uncommon but important cause of liver disease that is challenging to diagnose and identify in the electronic medical record (EMR). AIM: To develop an accurate, reliable, and efficient method of identifying patients with bonafide DILI in an EMR system. METHODS: In total, 527,000 outpatient and ER encounters in an EPIC-based EMR were searched for potential DILI cases attributed to eight drugs...
March 2017: Digestive Diseases and Sciences
Ran Nissan, Alina Poperno, Gideon Y Stein, Barak Shapira, Shmuel Fuchs, Ronny Berkovitz, Zipora Hess, Mickey Arieli
Detection of Phosphodiesterase Type 5 (PDE-5) inhibitors and their analogues in "100% natural" or "herbal" supplements have been described in numerous reports. However, few reports have been published in relation to actual harm caused by counterfeit erectile dysfunction herbal supplements. We describe a case of a 65-year old male admitted to a tertiary hospital with acute liver toxicity, possibly induced by adulterated "Chinese herbal" supplement "Tiger King" for sexual enhancement. Chemical analysis of the tablets discovered the presence of therapeutic doses of sildenafil with no other herbal components...
2016: Current Drug Safety
Paul B Watkins
The diagnosis of drug-induced liver injury (DILI) is largely a diagnosis of exclusion because, with the possible exception of protein:drug adducts in paracetamol overdose, there are no laboratory, biopsy or imaging tests that alone are capable of establishing an unequivocal diagnosis of DILI. However, it is increasingly appreciated that drugs that cause DILI typically have characteristic clinical presentations or 'signatures' that can be very useful in the diagnosis of DILI. Indeed, knowing a drug's DILI signature (or sometimes signatures) and the incidence rate of DILI during treatment with that drug are perhaps the most useful pieces of historical information in arriving at the diagnosis of DILI...
2015: Digestive Diseases
Fernando Bessone, M I Lucena, Marcelo G Roma, Camilla Stephens, Inmaculada Medina-Cáliz, Bernardo Frider, Guillermo Tsariktsian, Nelia Hernández, Miquel Bruguera, Gisela Gualano, Eduardo Fassio, Joaquín Montero, María V Reggiardo, Sebastián Ferretti, Luis Colombato, Federico Tanno, Jaime Ferrer, Lelio Zeno, Hugo Tanno, Raúl J Andrade
BACKGROUND & AIMS: Cyproterone acetate (CPA), an anti-androgenic drug for prostate cancer, has been associated with drug-induced liver injury (DILI). We aim to expand the knowledge on the spectrum of phenotypes and outcomes of CPA-induced DILI. METHODS: Twenty-two males (70 ± 8 years; range 54-83) developing liver damage as a result of CPA therapy (dose: 150 ± 50 mg/day; range 50-200) were included. Severity index and causality by RUCAM were assessed. RESULTS: From 1993 to 2013, 22 patients were retrieved...
February 2016: Liver International: Official Journal of the International Association for the Study of the Liver
Andreas Benesic, Alexandra Leitl, Alexander L Gerbes
BACKGROUND: Idiosyncratic drug-induced liver injury (iDILI) is a frequent cause of acute liver injury and a serious problem in late stage drug-development. Its diagnosis is one of the most challenging in hepatology, since it is done by exclusion and relies on expert opinion. Until now no reliable in vitro test exists to support the diagnosis of iDILI. In some instances it is impossible to determine the causative drug in polymedicated patients. AIM: To investigate if monocyte-derived hepatocyte-like (MH) cells might be a tool supporting clinical judgment for iDILI diagnosis and causality assessment...
September 2016: Gut
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
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
E Shelton, K Chaudrey, J Sauk, H Khalili, R Masia, D D Nguyen, V Yajnik, A N Ananthakrishnan
BACKGROUND: Anti-tumour necrosis factor α (anti-TNF) agents have been implicated in drug-induced liver injury. There is minimal data on this occurrence in inflammatory bowel disease (IBD) patients. AIM: To identify the characteristics of liver enzyme elevations following anti-TNF therapy initiation in IBD. METHODS: A retrospective cohort of patients initiating anti-TNF therapy were analysed for new onset alanine transaminase (ALT) elevation (≥60 U/L)...
May 2015: Alimentary Pharmacology & Therapeutics
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