Hepatotoxicity by drugs and dietary supplements: safety perspectives on clinical and regulatory issues
Journal Title: Annals of Hepatology - Year 2009, Vol 8, Issue 3
Abstract
Hepatotoxicity by drugs and dietary supplements (DDS) is a rare and unpredictable event but with the risk of a life-threatening clinical course when it occurs. It may emerge despite intensive chemical, toxicological and observational studies that indicate no hepatotoxic signals. This suggests major clinical and regulatory issues that must be addressed in the area of accurate testing, reporting, and accessibility of reliable n data. Consequently, in a clinical setting, safety concerns are key elements in the treatment of patients, and require that the diagnosis of DDS hepatotoxicity clearly be established. Causality of DDS hepatotoxicity may be pursued using a diagnostic algorithm consisting of a pre-test, a main-test as the scale of the updated CIOMS (Council for International Organizations of Medical Sciences), and a post-test. The results of these tests are then sent item by item to the National Health Agency, where the case will undergo further evaluation for pharmacovigilance, strategic aspects and safety issues. After this analysis, all items of the tests are included in the regulatory database freely accessible to the health and scientific community. With this diagnostic and regulatory algorithm the risk of misdiagnoses and inappropriate regulatory measures may be minimized and the safety improved. In conclusion,DDS hepatotoxicity is a rare but is a potentially life-threatening entity requiring a reliable diagnosis with the aid of a diagnostic algorithm, and a thorough pharmacovigilance evaluation by national and international health agencies. Safety aspects in DDS hepatotoxicity represent a major clinical and regulatory issue and should consequently be addressed.
Authors and Affiliations
Rolf Teschke
Genotype f prevails in Venezuelan urban patients with chronic hepatitis B
Hepatitis B virus (HBV) has been classified into 8 genotypes (A-H). Genotypes A, D and F have been identified in some South American countries, but in Venezuela studies have been more restricted to aboriginal communities...
Non-invasive markers of liver fibrosis in chronic liver disease in a group of Mexican children. A multicenter study
Introduction. Identifying liver fibrosis is important to evaluate the severity of liver damage and to establish a prognosis. Utility of non-invasive markers of liver fibrosis has been proved in adults but there are few r...
Noninvasive assessment of hepatic fibrosis using gadoxetate-disodium-enhanced 3T MRI
Introduction. Gadoxetate-disodium is a liver-specific MR contrast agent absorbed by hepatocytes via organic anion transporting polypeptide 1B3 and is excreted into the biliary system by multidrug resistance-associated pr...
Multiple Biliary Hamartomas, The ‘‘Von Meyenburg Complexes’’
-
Fibrin-mediated integrin signaling plays a critical role in hepatic regeneration after partial hepatectomy in mice
Background. The regenerative capacity of the liver is critical for proper responses to injury. Fibrin extracellular matrix (ECM) deposition is a common response to insult and contributes to inflammatory liver injury. Ho...