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Hepatotoxic Drugs (hepatotoxic + drug)
Selected AbstractsCase-crossover study of hospitalization for acute hepatitis in Chinese herb usersJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 10 2008Chang-Hsing Lee Abstract Background and Aim:, Despite the increase in popularity of herbal products, there is growing concern over potential health hazards caused by the Chinese herbal medicines (CHMs) that are regularly reimbursed under the National Health Insurance system in Taiwan. This study attempts to determine the association between CHM prescriptions and acute hepatitis,related hospitalizations. Methods:, A case-crossover study was designed on 200 000 randomly selected individuals from the National Health Insurance Research Database who were then followed from 1997 to 2002. All medications taken in the 30- and 60-day periods prior to hospitalization were explored and compared with four control periods (the 180- and 360-day periods prior to and after the hospitalization). A conditional logistic regression model was then constructed to determine the odds of CHM being prescribed during these risk periods. Results:, There were a total of 12 cases with nonviral, nonalcoholic hepatitis patients who took CHM prescriptions during the 30-day risk or control periods. After adjustment for conventional hepatotoxic drugs, the odds ratio during the 30-day risk period was 3.4 (95% confidence interval [CI]: 1.1, 9.8) for nonviral, nonalcoholic acute hepatitis. A detailed historical review of CHMs for each patient revealed that the odds ratio increased to 4.2 for those prescribed formulae containing Radix Paeoniae (95% CI: 1.1, 15.7) and Radix Glycyrrhizae (95% CI: 1.2, 15.2). Conclusions:, Chinese herbal users revealed a slightly increased risk of acute hepatitis. We therefore recommend pharmacovigilance and active surveillance for CHMs suspected with hepatotoxicity. [source] Liver cirrhosis in HIV-infected patients: prevalence, aetiology and clinical outcomeJOURNAL OF VIRAL HEPATITIS, Issue 3 2008C. Castellares Summary., Liver disease is frequently seen in HIV+ patients as a result of coinfection with hepatitis B (HBV) or C (HCV) viruses, alcohol abuse and/or exposure to hepatotoxic drugs. The aim of this study was to assess the prevalence of liver cirrhosis, its main causes and clinical presentation in HIV+ patients. Observational, cross-sectional, retrospective study of all HIV+ individuals followed at one reference HIV outpatient clinic in Madrid. Liver fibrosis was measured in all cases using transient elastometry (FibroScan®). All 2168 HIV+ patients on regular follow-up (76% males, 46% injecting drug users) were successfully examined by FibroScan® between October 2004 and August 2006. Liver cirrhosis was recognized in 181 (overall prevalence, 8.3%), and the main aetiologies were HCV, 82.3%; HBV, 1.6%; dual HBV/HCV, 2.8%; and triple HBV/HCV/ hepatitis delta virus (HDV) infection, 6.6%. The prevalence of cirrhosis differed among patients with distinct chronic viral hepatitis: HCV, 19.2%; HBV, 6.1%; HBV/HCV, 41.7%; and HBV/HCV/HDV, 66.7%. In 12 patients with cirrhosis (6.7%), no definite aetiology was recognized. Overall, cirrhotics had lower mean CD4 counts than noncirrhotics (408 vs 528 cells/,L respectively; P = 0.02), despite similar proportion of subjects with undetectable viraemia on highly active antiretroviral therapy. Clinical manifestations of liver cirrhosis were: splenomegaly, 61.5%; oesophageal varices, 59.8%; ascites, 22.6%; encephalopathy, 12.1%; and variceal bleeding, 6.1%. Liver cirrhosis and hepatic decompensation events are relatively frequent in HIV+ individuals. Chronic HCV and alcohol abuse, but not chronic HBV, play a major role. Transient elastometry may allow the identification of a significant number of HIV+ individuals with asymptomatic liver cirrhosis. [source] What is prescription labeling communicating to doctors about hepatotoxic drugs?PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2004A study of FDA approved product labeling Abstract Purpose The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States. Methods We searched the Physicians' Desk Reference,2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the ,informativeness' and consistency of the labeling content. An informativeness score equaled the proportion of checklist items present in each drug's labeling. Results Ninety-five prescription drugs were included in the study. Eleven (12%) of the drugs had information related to hepatic failure in a Black Boxed Warning, 52 (54%) in the Warnings section and 32 (34%) in the Adverse Reactions section of the label. The mean informativeness score was 35%; the score was significantly higher, 61%, when the risk was perceived to be high. The informativeness of labeling was not affected by the time of the labeling, but differed across the Center for Drug Evaluation and Research (CDER) Review Division responsible for the labeling. Conclusions The information provided in labeling is variable and affected by many factors, including the perceived level of risk and review division strategy. Product labeling may benefit from current FDA initiatives to improve the consistency of risk-related labeling. Published in 2003 by John Wiley & Sons, Ltd. [source] | ||||||||||