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drug-induced liver injury guidelines

Muzamil Latief, Waseem Raja Dar, Najeebullah Sofi, Imtiyaz Ahmad Dar, Basharat Kasana, Moomin Hussain, Faheem Arshad, Bashir Ahmad Shah, Parvaiz Ahmad Koul
INTRODUCTION: ATT remains the standard treatment for tuberculosis. Drug-induced liver injury (DILI) has been a long-standing concern in the treatment of tuberculosis (TB) infection. AIMS AND OBJECTIVES: To study the occurrence and risk factors of DILI in patients on ATT by regular clinical and biochemical monitoring. MATERIALS AND METHODS: 200 patients, in whom ATT was started, were enrolled in the study. None of the patients with established risk factor for DILI as recognized by ATS guidelines was included in our study population...
January 2017: Indian Journal of Tuberculosis
Sebastian J Wallace, Glynn W Webb, Richie G Madden, Hugh C Dalton, Joanne Palmer, Richard T Dalton, Adam Pollard, Rhys Martin, Vasilis Panayi, Gwyn Bennett, Richard P Bendall, Harry R Dalton
AIM: Hepatitis E virus (HEV) is endemic in developed countries, but unrecognized infection is common. Many national guidelines now recommend HEV testing in patients with acute hepatitis irrespective of travel history. The biochemical definition of 'hepatitis' that best predicts HEV infection has not been established. This study aimed to determine parameters of liver biochemistry that should prompt testing for acute HEV. METHODS: This was a retrospective study of serial liver function tests (LFTs) in cases of acute HEV (n=74) and three comparator groups: common bile duct stones (CBD, n=87), drug-induced liver injury (DILI, n=69) and patients testing negative for HEV (n=530)...
February 2017: European Journal of Gastroenterology & Hepatology
Elena Cabb, Shanna Baltar, David Wes Powers, Karthik Mohan, Antonio Martinez, Eric Pitts
Drug-induced liver injury (DILI) presents as a broad spectrum of adverse drug reactions which can range from a mild elevation in liver enzymes to fulminant liver failure. The primary goal is to identify DILI early when the patient's liver enzymes are elevated and to discontinue the offending agent as soon as possible to prevent further injury. Herbal, dietary supplements and anabolic steroids represent a significant component of the drugs thought to cause DILI in the United States. Unlike all other drugs known to cause DILI, these drugs fall into a category of injury that is neither intrinsic nor idiosyncratic due to overlapping characteristics between the two...
May 2016: Case Reports in Gastroenterology
Young Mi Hong, Ki Tae Yoon, Jeong Heo, Hyun Young Woo, Won Lim, Dae Seong An, Jun Hee Han, Mong Cho
Analgesics, known to be hepatotoxic drugs, are frequently prescribed to patients with liver cirrhosis who are prone to drug-induced liver injury. No guidelines are available regarding the prescription of analgesics in these patients. Therefore, we aimed to evaluate the prescription pattern of most frequently used analgesics in patients with cirrhosis. We assessed the prescription pattern of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with liver cirrhosis registered in Health Insurance Review Assessment Service database between January 1, 2012 and December 31, 2012...
October 2016: Journal of Korean Medical Science
Jaymon Patel, Saqib Walayat, Nikhil Kalva, Sidney Palmer-Hill, Sonu Dhillon
Bile cast nephropathy is a condition of renal dysfunction in the setting of hyperbilirubinemia. There are very few cases of this condition reported in the last decade and a lack of established treatment guidelines. While the exact etiology remains unknown, bile cast nephropathy is presumed to be secondary to multiple concurrent insults to the kidney including direct toxicity from bile acids, obstructive physiology from bile casts, and systemic hypoperfusion from vasodilation. Therapy directed at bilirubin reduction may improve renal function, but will likely need dialysis or plasmapheresis as well...
July 21, 2016: World Journal of Gastroenterology: WJG
Mathieu Vinken
Adverse outcome pathways (AOPs) are novel tools in toxicology and human risk assessment with broad potential. AOPs are designed to provide a clear-cut mechanistic representation of toxicological effects that span over different layers of biological organization. AOPs share a common structure consisting of a molecular initiating event, a series of key events connected by key event relationships, and an adverse outcome. Development and evaluation of AOPs ideally complies with guidelines issued by the Organization for Economic Cooperation and Development...
2016: Methods in Molecular Biology
Nobuyuki Horita, Naoki Miyazawa, Takashi Yoshiyama, Ryota Kojima, Yoshiaki Ishigatsubo, Takeshi Kaneko
OBJECTIVE: In the 1950s, a high-dose (40-70 mg/kg/day) of pyrazinamide (PZA), was reported to cause drug-induced liver injury (DILI) at an unacceptable frequency. It remains unclear whether adding PZA (Z) at the currently accepted low-dose (20-25 mg/kg/day) for two months to a regimen of isoniazid (H) + rifampicin (R) + ethambutol (E) actually increases the risk of DILI. METHOD: Smear-positive tuberculosis patients were treated with daily HRE or HRZE regimen under direct observation...
2015: Internal Medicine
(no author information available yet)
No abstract text is available yet for this article.
2015: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
Simin Zhang, Hongqiu Pan, Xianzhen Peng, Hui Lu, Hong Fan, Xianzhi Zheng, Guisheng Xu, Min Wang, Jianming Wang
BACKGROUND AND AIM: Hepatoprotectants are routinely prescribed in China to prevent anti-tuberculosis drug-induced liver injury (ATLI). However, their biological mechanisms have not yet been clearly demonstrated. This study aims to evaluate the preventive effects of Silybum marianum against drug-induced liver injury among tuberculosis patients and to provide clinical guidelines for tuberculosis management in China. METHODS: A randomized controlled trial was performed in Jiangsu, China...
February 2016: Journal of Gastroenterology and Hepatology
James H Lewis
Drug-induced liver injury (DILI) remains a leading reason why new compounds are dropped from further study or are the subject of product warnings and regulatory actions. Hy's Law of drug-induced hepatocellular jaundice causing a case-fatality rate or need for transplant of 10% or higher has been validated in several large national registries, including the ongoing, prospective U.S. Drug-Induced Liver Injury Network. It serves as the basis for stopping rules in clinical trials and in clinical practice. Because DILI can mimic all known causes of acute and chronic liver disease, establishing causality can be difficult...
November 2015: Clinical Gastroenterology and Hepatology
Thomas Powles, Sergio Bracarda, Mei Chen, Elliot Norry, Natalie Compton, Mark Heise, Thomas Hutson, Philipp Harter, Christopher Carpenter, Lini Pandite, Neil Kaplowitz
Drug-induced liver chemistry abnormalities, primarily transaminase elevations, are commonly observed in pazopanib-treated patients. This meta-analysis characterises liver chemistry abnormalities associated with pazopanib. Data of pazopanib-treated patients from nine prospective trials were integrated (N=2080). Laboratory datasets were used to characterise the incidence, timing, recovery and patterns of liver events, and subsequent rechallenge with pazopanib. Severe cases of liver chemistry abnormalities were clinically reviewed...
July 2015: European Journal of Cancer
Shigeo Yamaguchi, Shunsuke Kato
No abstract text is available yet for this article.
February 2015: Nihon Rinsho. Japanese Journal of Clinical Medicine
Ronan T Swords, Harry P Erba, Daniel J DeAngelo, Dale L Bixby, Jessica K Altman, Michael Maris, Zhaowei Hua, Stephen J Blakemore, Hélène Faessel, Farhad Sedarati, Bruce J Dezube, Francis J Giles, Bruno C Medeiros
This trial was conducted to determine the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of the first in class NEDD8-activating enzyme (NAE) inhibitor, pevonedistat, and to investigate pevonedistat pharmacokinetics and pharmacodynamics in patients with acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). Pevonedistat was administered via a 60-min intravenous infusion on days 1, 3 and 5 (schedule A, n = 27), or days 1, 4, 8 and 11 (schedule B, n = 26) every 21-days. Dose escalation proceeded using a standard '3 + 3' design...
May 2015: British Journal of Haematology
Paul H Hayashi, Robert J Fontana, Naga P Chalasani, Andrew A Stolz, Jay A Talwalkar, Victor J Navarro, William M Lee, Timothy J Davern, David E Kleiner, Jiezhun Gu, Jay H Hoofnagle
BACKGROUND & AIMS: Isoniazid is a leading cause of liver injury but it is not clear how many cases are reported or how many clinicians and patients adhere to American Thoracic Society (ATS) guidelines. We collected data on cases of isoniazid hepatotoxicity and assessed adherence to ATS guidelines and reports to the Centers for Disease Control's (CDC) isoniazid severe adverse events program. METHODS: We analyzed Drug-Induced Liver Injury Network (DILIN) cases considered definite, highly likely, or probable for isoniazid injury from 2004 through 2013...
September 2015: Clinical Gastroenterology and Hepatology
Natasha Palipane, Estabrak Jiad, Jacob F de Wolff
No abstract text is available yet for this article.
February 2015: British Journal of Hospital Medicine
Roberta Elisa Rossi, Ioanna Parisi, Edward John Despott, Andrew Kenneth Burroughs, James O'Beirne, Dario Conte, Mark Ian Hamilton, Charles Daniel Murray
Abnormalities in liver function tests, including transient and self-limiting hypertransaminasemia, cholestatic disease and hepatitis, can develop during treatment with anti-tumour-necrosis-factor (TNF) therapy. The optimal management of liver injury related to anti-TNF therapy is still a matter of debate. Although some authors recommend discontinuing treatment in case of both a rise of alanine aminotransferase more than 5 times the upper limit of normal, or the occurrence of jaundice, there are no standard guidelines for the management of anti-TNF-related liver injury...
December 14, 2014: World Journal of Gastroenterology: WJG
Marc-Andre Cornier, Robert H Eckel
In this manuscript, three manifestations of statin intolerance will be covered. The first, myopathy, is mostly subjective with variable complaints of myalgias often worsened by exercise, muscle cramping or weakness, and at times associated with a biomarker, elevations in creatine kinase (CK). A rare but serious manifestation can be rhabdomyolysis. The second, liver toxicity, is associated with reversible biochemical increases in transaminases and rarely other liver function tests. Finally, statin-related central nervous system (CNS) toxicity typically defined as cognitive impairment is quite rare and appears to be idiosyncratic...
2015: Current Atherosclerosis Reports
Aditya K Gupta, Deanne Daigle, Kelly A Foley
INTRODUCTION: Ketoconazole was the first broad-spectrum oral antifungal approved by the FDA in 1981. Post-marketing reports of drug-related hepatotoxicity, endocrine dysregulation and drug interactions resulted in market withdrawal of the drug in some countries and strict product relabeling in others. AREAS COVERED: This drug safety review summarizes reports of oral ketoconazole-related adverse events retrieved from a search of the PubMed database using the search strategy 'ketoconazole OR Nizoral AND hepat*', references from relevant publications, and data from the FDA Adverse Event Reporting System...
February 2015: Expert Opinion on Drug Safety
Gerd A Kullak-Ublick, Michael Merz, Louis Griffel, Neil Kaplowitz, Paul B Watkins
The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects...
November 2014: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Bader Faiyaz Zuberi, Faisal Faiyaz Zuberi, Nimrah Bader, Haris Alvi, Javeria Salahuddin
OBJECTIVE: To compare the efficacy of British Thoracic Society and American Thoracic Society guidelines for reintroduction of anti-tuberculous therapy after drug-induced liver injury, and to assess the ease of administration of each guideline on a scale of 1-10. METHODS: The randomised prospective interventional study was conducted at the Department of Medicine and Pulmonology, Dow University of Health Sciences, Karachi, from December 2011 to November 2013. Patients with anti-tuberculous therapy drug-induced liver injury were selected...
August 2014: JPMA. the Journal of the Pakistan Medical Association
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