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Hepatotoxic Medication

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101. Thiopurine S-methyltransferase testing for averting drug toxicity in patients receiving thiopurines: A systematic review and quality appraisal

of Effects DHPLC Denaturing high performance liquid chromatography gHb Gram of hemoglobin h Hour Hb Hemoglobin HPLC High performance liquid chromatography HTA Health Technology Assessment IBD Inflammatory Bowel Disease IPA International Pharmaceutical Abstracts ITPA Inosine triphosphatase MA meta-analysis MALDI-TOF MS Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass spectrometry MeSH Medical Subject Headings Mg Milligram Min Minute ix Ml Millilitre MS Access Microsoft Access MTG (...) . The absence or a deficiency of TPMT can significantly increase the risk of adverse drug event (ADE) in persons receiving thiopurine therapy as they are unable to metabolize the drug. There has long been phenotype blood testing to measure TPMT enzyme activity, and more recently a genotype test is sued to identify individual as with the genetic variants that determine TPMT activity. Uncertainty remains however, regarding which is the optimal test. Objectives The objectives of this study were

2015 SickKids Reports

102. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for <em>CYP2C19</em> and voriconazole therapy.

. Uridine 5'-diphosphoglucuronosyltransferase glucuronidation of posaconazole is not significantly affected by genetic variation. Administration of posaconazole should still be guided by TDM. Other Considerations Further dose adjustments of voriconazole or selection of alternative therapy may be necessary due to other clinical factors, such as drug interactions, hepatic function, fungal species, TDM, comorbidities, and site of infection. Assessment of drug interactions with a patient's concomitant (...) appropriate agent, based on clinical advice, for a patient with poor metabolizer genotype, voriconazole should be administered at a preferably lower than standard dosage with careful therapeutic drug monitoring. Moderate a Further dose adjustments or selection of alternative therapy may be necessary due to other clinical factors, such as drug interactions, hepatic function, renal function, species, site of infection, therapeutic drug monitoring, and comorbidities. b Recommendations based upon data

2017 National Guideline Clearinghouse (partial archive)

103. Second-line hormonal therapy for men with chemotherapy-na&iuml

of ≥50% from baseline (v placebo). The drug is also well tolerated. Alternative treatment options include immunotherapy (sipuleucel-T) (Kantoff et al., 2010), chemotherapy (docetaxel and prednisone) (Basch et al., 2014), and radium-223. If none of these therapies can be obtained or tolerated by the patient, other antiandrogens, prednisone, and ketoconazole/hydrocortisone may be offered because they provide modest clinical benefits in this population, but no survival benefits have been established (...) of cardiovascular disease. Drug safety was not established in patients with a left-ventricular ejection fraction <50% or with New York Heart Association class II to IV disease. Abiraterone acetate can cause hypertension, hypokalemia, and fluid retention. Low risks of adrenocortical insufficiency or hepatotoxicity also are associated with abiraterone acetate use. A low risk of seizure associated with enzalutamide use exists; however, among chemotherapy-naïve patients, the risk (0.1%) was similar between those

2017 National Guideline Clearinghouse (partial archive)

104. Pomalidomide (Imnovid): risks of cardiac failure, interstitial lung disease and hepatotoxicity

liver function for the first 6 months of pomalidomide treatment and as clinically indicated thereafter please continue to report suspected adverse drug reactions to pomalidomide or any other medicines on a Pomalidomide in combination with dexamethasone is licensed to treat adults with relapsed and refractory multiple myeloma who have received at least two treatments, including lenalidomide and bortezomib, and whose disease has worsened since the last treatment. A review by the MHRA and other EU (...) medicines regulators concluded that pomalidomide can cause interstitial lung disease (ILD), cardiac failure and hepatotoxicity. This conclusion was based on data from clinical trials, reports from clinical practice and published case reports. Cardiac failure The review concluded that this side effect is common (ie occurs in between 1/10 and 1/100 patients who take pomalidomide). In most cases, this side effect occurred in patients with cardiac disease or cardiac risk factors and within 6 months

2015 MHRA Drug Safety Update

105. Evaluation of Silymarin for management of anti-tuberculosis drug induced liver injury: a randomized clinical trial. (Abstract)

Evaluation of Silymarin for management of anti-tuberculosis drug induced liver injury: a randomized clinical trial. This study was performed to evaluate the potential efficacy of silymarin in the management of anti-tuberculosis medication's induced liver injury.Hepatic toxicity is the most serious complication in treatment of tuberculosis.In a randomized double blind clinical trial (ACTRN12610000643077), 55 cases with hepatotoxicity caused by anti-tuberculosis drugs were divided into two groups (...) . Informed consents were obtained. The intervention group received silymarin and the control group received placebo. Severity of liver injury, the duration necessary for normalization of liver function and hospital stay were compared between the two groups.There was not any statistically significant difference in the rate of adverse effects between silymarin and placebo groups.Although silymarin is considered a safe herbal medication, it was not effective to treat hepatic toxicity of anti-tuberculosis

2019 Gastroenterology and hepatology from bed to bench Controlled trial quality: uncertain

106. Tools for causality assessment in drug-induced liver disease. (Abstract)

to scoring systems. For example, the incorporation of drug-specific clinical signature patterns, accounting for a drug's inherent hepatotoxicity potential, and/or incorporation of other drug properties to scoring systems may allow enhancement. Further, more systemic exclusion of competing diagnoses is needed. Finally, causality assessment processes will likely benefit from a data-driven and computer-assisted approach.Current tools used for DILI adjudication are imperfect. Avenues to improve these tools (...) Tools for causality assessment in drug-induced liver disease. There are three liver-specific causality assessment tools currently available to guide clinical diagnosis of Drug-Induced Liver Injury (DILI): Roussel-Uclaf Causality Assessment Method (RUCAM), Digestive-Disease-Week Japan 2004 scale (DDW-J), and Clinical Diagnostic Scale (CDS). The purpose of this review is to assess these tools and discuss how to improve the causality assessment process as a whole.Existing DILI-specific causality

2019 Current opinion in gastroenterology

107. Drug utilization patterns of flupirtine following implementation of risk minimization measures in Germany. (Abstract)

flupirtine for up to 14 days increased significantly by 22.7%, from 67.9% to 90.6% in the pre- to post-implementation periods, respectively. Over half the patients received long-term medications for conditions contraindicated with the use of other analgesics within 12 months prior to the first flupirtine prescription in the pre- and post-implementation periods (57.1% and 52.3%, respectively). Concomitant prescriptions of drugs with known potential hepatotoxic effects were recorded in 36.6% and 34.2 (...) Drug utilization patterns of flupirtine following implementation of risk minimization measures in Germany. This report characterizes flupirtine prescribing patterns before and after the implementation of risk minimization measures (RMM) in Germany as a complementary analysis to support previous study findings.A retrospective analysis was conducted using a patient-level longitudinal prescription database (IMS® LRx) in Germany. The study population included patients who were prescribed flupirtine

2019 Current medical research and opinion

108. Tuberculosis treatment with a three drug rifamycin-free regimen in liver transplant recipients. (Abstract)

Tuberculosis treatment with a three drug rifamycin-free regimen in liver transplant recipients. Active tuberculosis (TB) is a severe and potentially fatal complication of liver transplantation (1). The management of TB in liver transplant (LT) recipients is challenging not only because of the severity of this infection, but because first-line TB treatment is associated with significant hepatotoxicity and drug interactions.Copyright © 2019 by the American Association for the Study of Liver

2019 Liver Transplantation

109. Assessment of Serious Acute and Chronic Idiosyncratic Drug-Induced Liver Injury in Clinical Practice. (Abstract)

Assessment of Serious Acute and Chronic Idiosyncratic Drug-Induced Liver Injury in Clinical Practice. Drug-induced liver injury (DILI) is the leading cause of acute liver failure (ALF) in developed countries. The extremely variable phenotype of DILI, both in presentation and in severity, is one of the distinctive characteristics of the disease and one of the major challenges that hepatologists face when assessing hepatotoxicity cases. A new Hy's law that more accurately predicts the risk of ALF (...) are discussed in this study. Biomarkers to predict DILI outcome are in need.Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

2019 Seminars in Liver Disease

110. EASL Clinical Practice Guidelines: Drug-induced liver injury. Full Text available with Trip Pro

liver injury an uncertain process, requiring a high degree of awareness of the condition and the careful exclusion of alternative aetiologies of liver disease. Idiosyncratic hepatotoxicity can be severe, leading to a particularly serious variety of acute liver failure for which no effective therapy has yet been developed. These Clinical Practice Guidelines summarize the available evidence on risk factors, diagnosis, management and risk minimization strategies for drug-induced liver jury.Copyright © (...) EASL Clinical Practice Guidelines: Drug-induced liver injury. Idiosyncratic (unpredictable) drug-induced liver injury is one of the most challenging liver disorders faced by hepatologists, because of the myriad of drugs used in clinical practice, available herbs and dietary supplements with hepatotoxic potential, the ability of the condition to present with a variety of clinical and pathological phenotypes and the current absence of specific biomarkers. This makes the diagnosis of drug-induced

2019 Journal of Hepatology

111. A prospective study of the incidence of drug-induced liver injury by the modern volatile anaesthetics sevoflurane and desflurane. (Abstract)

A prospective study of the incidence of drug-induced liver injury by the modern volatile anaesthetics sevoflurane and desflurane. Volatile anaesthetics are known to cause drug-induced liver injury, a hepatotoxic reaction characterised by antibodies to trifluoroacetylated lipid and protein adducts and cytochrome p450 2E1. The incidence of volatile anaesthetic drug-induced liver injury from older agents has been described, but modern agents have not been prospectively studied.To determine (...) prospectively the incidence of volatile anaesthetic drug-induced liver injury from sevoflurane and desflurane.Adult surgical patients with a predicted post-operative stay of at least 4 days were recruited. If volatile anaesthetic was administered, liver biochemistry was performed regularly. Medications, observations and other investigations were documented. Patients with abnormal liver biochemistry were classified as likely volatile anaesthetic drug-induced liver injury or not based on clinical assessment

2019 Alimentary Pharmacology & Therapeutics

112. Effects of pharmaceutical formulations containing thyme on carbon tetrachloride-induced liver injury in rats. Full Text available with Trip Pro

Effects of pharmaceutical formulations containing thyme on carbon tetrachloride-induced liver injury in rats. Herbal supplements are widely used in the treatment of various liver disases, but some of them may also induce liver injuries. Regarding the infuence of thyme and its constituents on the liver, conflicting results have been reported in the literature. The objective of this study was to examine the influence of two commonly used pharmaceutical formulations containing thyme (Thymus (...) to be predominant active constituent in both tincture and syrup. Investigated thyme preparations exerted antioxidant effects in liver by preventing carbon tetrachloride-induced increase of lipid peroxidation. Furthermore, co-treatment with thyme preparations reversed the activities of oxidative stress-related enzymes xanthine oxidase, catalase, peroxidase, glutathione peroxidase and glutathione reductase, towards normal values in the liver. Hepatotoxicity induced by carbon tetrachloride was reflected

2015 BMC Complementary and Alternative Medicine

113. Improvement of mitochondrial function by Tapinanthus globifer (A.Rich.) Tiegh. Against hepatotoxic agent in isolated rat's liver mitochondria. (Abstract)

Improvement of mitochondrial function by Tapinanthus globifer (A.Rich.) Tiegh. Against hepatotoxic agent in isolated rat's liver mitochondria. Disturbed mitochondrial function and energy crisis serve as key mechanisms for the development of liver injury. Hence, targeting cellular mitochondria in liver diseases might serve as a therapeutic option. Tapinanthus globifer (A.Rich.) Tiegh. has been used in traditional medicine in the management of liver disease. However, there is no scientific (...) evidence supporting such use.The current investigation was designed to evaluate the protective role of Tapinanthus globifer treatment on the liver mitochondrial function after the induction of hepatotoxicity by the hepatotoxic agent Fe2+in vitro.In this study, isolated mitochondria from rats' liver was incubated with Fe2+ (10 μM) for 1 h in the absence or presence of T. globifer (50, 100 and 200 μg/mL) metanolic extract (MVA). Mitochondrial viability, mitochondrial membrane potential (ΔΨm

2019 Journal of Ethnopharmacology

114. Acetaminophen Hepatotoxicity. Full Text available with Trip Pro

Acetaminophen Hepatotoxicity. Acetaminophen (APAP) is one of the most popular and safe pain medications worldwide. However, due to its wide availability, it is frequently implicated in intentional or unintentional overdoses where it can cause severe liver injury and even acute liver failure (ALF). In fact, APAP toxicity is responsible for 46% of all ALF cases in the United States. Early mechanistic studies in mice demonstrated the formation of a reactive metabolite, which is responsible (...) death and the resulting inflammatory response. Furthermore, it discusses the translation of these findings to humans and the emergence of new therapeutic interventions.Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

2019 Seminars in Liver Disease

115. Hepatotoxicity induced by Isoniazid/Lipopolysaccharide through ERS-, autophagy- and apoptosis pathway in zebrafish. Full Text available with Trip Pro

Hepatotoxicity induced by Isoniazid/Lipopolysaccharide through ERS-, autophagy- and apoptosis pathway in zebrafish. Isoniazid (INH) is a first-line antituberculosis drug. The incidence of adverse reactions accompanied by inflammation in the liver during drug administration to tuberculosis patients is high and severely affects clinical treatment. To better understanding the mechanism of hepatotoxicity induced by INH under the inflammatory state, we compared the differences in hepatotoxicity from (...) INH between normal and inflammatory zebrafish to elucidate the hepatotoxic mechanism using different endpoints such as mortality, malformation, inflammatory effects, liver morphology, histological changes, transaminase analysis and certain genes expression. The results showed that the toxic effect of INH in inflammatory zebrafish was more obvious than that in normal zebrafish, liver areas were significantly decreased measured by lfabp reporter fluorescence and intensity, and ALT and AST levels

2019 Antimicrobial Agents and Chemotherapy

116. Phase I study of PF‐04895162, a Kv7 channel opener, reveals unexpected hepatotoxicity in healthy subjects, but not rats or monkeys: clinical evidence of disrupted bile acid homeostasis. Full Text available with Trip Pro

Phase I study of PF‐04895162, a Kv7 channel opener, reveals unexpected hepatotoxicity in healthy subjects, but not rats or monkeys: clinical evidence of disrupted bile acid homeostasis. During a randomized Phase 1 clinical trial the drug candidate, PF-04895162 (ICA-105665), caused transaminase elevations (≥grade 1) in six of eight healthy subjects treated at 300 mg twice daily for 2-weeks (NCT01691274). This was unexpected since studies in rats (<6 months) and cynomolgus monkeys (<9 months (...) collectively suggest that the human liver injury by PF-04895162 was due to alterations in bile acid handling driven by dual BSEP/mitochondrial inhibition, two important risk factors associated with drug-induced liver injury in humans. Alterations in systemic bile acid composition were more important than total bile acids in the manifestation of clinical liver injury and may be a very early biomarker of BSEP inhibition.© 2019 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons

2019 Pharmacology research & perspectives Controlled trial quality: uncertain

117. A sub-chronic Xysmalobium undulatum hepatotoxicity investigation in HepG2/C3A spheroid cultures compared to an in vivo model. (Abstract)

A sub-chronic Xysmalobium undulatum hepatotoxicity investigation in HepG2/C3A spheroid cultures compared to an in vivo model. Traditional herbal medicines are utilized by 27 million South Africans. Xysmalobium undulatum (Uzara) is one of the most widely used traditional medicinal plants in Southern Africa. A false belief in the safety of herbal medicine may result in liver injury. Herb-induced liver injury (HILI) range from asymptomatic elevation of liver enzymes, to cirrhosis and in certain (...) instances even acute liver failure. Various in vitro and in vivo models are available for the pre-clinical assessment of drug and herbal hepatotoxicity. However, more reliable and readily available in vitro models are needed, which are capable of bridging the gap between existing models and real human exposure. Three-dimensional (3D) spheroid cultures offer higher physiological relevance, overcoming many of the shortcomings of traditional two-dimensional cell cultures.This study investigated

2019 Journal of Ethnopharmacology

118. Is Intravenous Acetylcysteine More Effective Than Oral Administration For the Prevention of Hepatotoxicity in Acetaminophen Overdose?

Washington University School of Medicine St. Louis, MO Results Pooled rates of hepatotoxicity with intravenous versus oral acetylcysteine. Time of administration Intravenous Acetylcysteine (95% CI), % Oral Acetylcysteine (95% CI), % Overall 13.2 (8.7–19.6) 12.6 (8.2–18.8) Early 5.3 (3.2–8.5) 5.9 (4.2–8.1) Late 23.3 (11.7–41.1) 26.3 (23.6–29.0) CI, Con?dence interval. Head-to-head randomized trials com- paring the ef?cacy of intravenous versus oral acetylcysteine were not identi?ed by the investigators (...) - ceived intravenous acetylcysteine and 1,023 (79.1%) received oral ace- tylcysteine. The rate of hepatotoxicity was similar for the intravenous and oral routes in both the early and late treatment groups. Although pediatric patients were included, only 5 studies included patients who were younger than 12 years. Data not reported in METHODS DATA SOURCES The authors of the systematic review searched EMBASE, MEDLINE, and International Pharmaceutical Abstracts through Ovid from 1966 to 2009. The search

2013 Annals of Emergency Medicine Systematic Review Snapshots

119. Adverse drug reactions

. Black Triangle products are new drugs and vaccines that are being intensively monitored by the MHRA to confirm their risk/benefit profile. Black Triangle products are marked with an inverted Black Triangle in the British National Formulary (BNF), the British National Formulary for Children (BNFC), the Monthly Index of Medical Specialties (MIMS), the Association of the British Pharmaceutical Industry (ABPI) Medicines Compendium, the MHRA Drug Safety Updates, Summaries of Product Characteristics (SPCs (...) studies, worldwide published medical literature, pharmaceutical companies, worldwide regulatory authorities, and morbidity and mortality databases. Pharmacovigilance and reporting of ADRs are important because the information collected during the pre-marketing phase of drug development is inevitably incomplete with regard to possible ADRs. This is because [ ; ]: Tests in animals are insufficient to predict human safety. Participants in clinical trials are selected and limited in number; the conditions

2017 NICE Clinical Knowledge Summaries

120. Drug-induced liver injury associated with Complementary and Alternative Medicine: a review of adverse event reports in an Asian community from 2009 to 2014. Full Text available with Trip Pro

Drug-induced liver injury associated with Complementary and Alternative Medicine: a review of adverse event reports in an Asian community from 2009 to 2014. The use of Complementary and Alternative Medicine (CAM) has been increasing over the years. A recent review of adverse event reports (AERs) associated with CAM in Singapore found a notable number of AERs submitted. The objectives of this study are to analyse hepatotoxicity cases associated with CAM in Singapore based on spontaneous adverse (...) event reporting to the Health Sciences Authority (HSA), and to highlight safety signals for specific herbal ingredients.AERs associated with CAM and hepatotoxicity submitted to the Vigilance and Compliance Branch (VCB) of the HSA from 2009 to 2014 were compiled. The following information was extracted and analysed: Demographic information; time to onset; hospitalisation status; outcome; type of hepatotoxicity; ingredients of CAM, and the total daily doses (TDD); concurrent western medicines

2016 BMC Complementary and Alternative Medicine

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