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The present study has been supported by grants of the Instituto de Salud Carlos III cofounded by Fondo Europeo de Desarrollo Regional - FEDER (contract numbers: PI12-00620, PI15-01440, AC-0073-2013, FIS PI12/00330, and FIS PI16/00043) and by the Agencia Espanola del Medicamento. CIBERehd is funded by Instituto de Salud Carlos III. SCReN and CIBERehd are funded by Instituto de Salud Carlos III.

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Herbal and Dietary Supplement-Induced Liver Injuries in the Spanish DILI Registry.

Publicated to:Clinical Gastroenterology And Hepatology. 16 (9): 1495-1502 - 2018-09-01 16(9), DOI: 10.1016/j.cgh.2017.12.051

Authors: Medina-Caliz I, Garcia-Cortes M, Gonzalez-Jimenez A, Cabello MR, Robles-Diaz M, Sanabria-Cabrera J, Sanjuan-Jimenez R, Ortega-Alonso A, García-Muñoz B, Moreno I, Jimenez-Perez M, Fernandez MC, Ginés P, Prieto M, Conde I, Hallal H, Soriano G, Roman E, Castiella A, Blanco-Reina E, Montes MR, Quiros-Cano M, Martin-Reyes F, Lucena MI, Andrade RJ, Spanish DILI Registry

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Abstract

There have been increasing reports of liver injury associated with use of herbal and dietary supplements, likely due to easy access to these products and beliefs among consumers that they are safer or more effective than conventional medications. We aimed to evaluate clinical features and outcomes of patients with herbal and dietary supplement-induced liver injuries included in the Spanish DILI Registry.We collected and analyzed data on demographic and clinical features, along with biochemical parameters, of 32 patients with herbal and dietary supplement-associated liver injury reported to the Spanish DILI registry from 1994 through 2016. We used analysis of variance to compare these data with those from cases of liver injury induced by conventional drugs or anabolic androgenic steroid-containing products.Herbal and dietary supplements were responsible for 4% (32 cases) of the 856 DILI cases in the registry; 20 cases of DILI (2%) were caused by anabolic androgenic steroids. Patients with herbal and dietary supplement-induced liver injury were a mean age of 48 years and 63% were female; they presented a mean level of alanine aminotransferase 37-fold the upper limit of normal, 28% had hypersensitivity features, and 78% had jaundice. Herbal and dietary supplement-induced liver injury progressed to acute liver failure in 6% of patients, compared with none of the cases of anabolic androgenic steroid-induced injury and 4% of cases of conventional drugs. Liver injury after repeat exposure to the same product that caused the first DILI episode occurred in 9% of patients with herbal and dietary supplement-induced liver injury vs none of the patients with anabolic androgenic steroid-induced injury and 6% of patients with liver injury from conventional drugs.In an analysis of cases of herbal and dietary supplement-induced liver injury in Spain, we found cases to be more frequent among young women than older patients or men, and to associate with hepatocellular injury and high levels of transaminases. Herbal and dietary supplement-induced liver injury is more severe than other types of DILI and re-exposure is more likely. Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses and reduce the risk of serious liver damage.Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

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