Search

Your search keyword '"B. García-Muñoz"' showing total 20 results
Start Over Author "B. García-Muñoz"
20 results on '"B. García-Muñoz"'

2. Clinical Characteristics and Outcome of Drug‐Induced Liver Injury in the Older Patients: From the Young‐Old to the Oldest‐Old

Author

Rianne A. Weersink, Ismael Alvarez‐Alvarez, Inmaculada Medina‐Cáliz, Judith Sanabria‐Cabrera, Mercedes Robles‐Díaz, Aida Ortega‐Alonso, Miren García‐Cortés, Elvira Bonilla, Hao Niu, German Soriano, Miguel Jimenez‐Perez, Hacibe Hallal, Sonia Blanco, Neil Kaplowitz, M. Isabel Lucena, Raúl J. Andrade, R.J. Andrade, M.I. Lucena, C. Stephens, M. García Cortés, M. Robles Díaz, A. Ortega Alonso, J. Pinazo, B. García Muñoz, R. Alcántara, A. Hernández, M.D. García‐Escaño, I. Medina‐Cáliz, J. Sanabria‐Cabrera, I. Alvarez‐Alvarez, E. Bonilla, H. Niu, D. Di‐Zeo, E. Del Campo, M. Jiménez Pérez, R. González Grande, S. López Ortega, I. Santaella, A. Ocaña, P. Palomino, M.C. Fernández, A. Porcel, M. Casado, M. González Sánchez, M. Romero‐Gómez, R. Millán‐Domínguez, B. Fombuena, R. Gallego, J. Ampuero, J.A. del Campo, R. Calle‐Sanz, L. Rojas, A. Rojas, A. Gil Gómez, E. Vilar, G. Soriano, C. Guarner, E.M. Román, M.A. Quijada Manuitt, R.M. Antonijoan Arbos, M. Farré, E. Montané, A.L. Arellano, A.M. Barriocanal, Y. Sanz, R.M. Morillas, M. Sala, H. Masnou Ridaura, J. Sánchez Delgado, M. Vergara Gómez, H. Hallal, E. García Oltra, J.C. Titos Arcos, A. Pérez Martínez, C. Sánchez Cobarro, J.M. Egea Caparrós, A. Castiella, J. Arenas, M.I. Gomez Osua, A. Gómez García, F.J. Esandi, S. Blanco, P. Martínez Odriozola, J. Crespo, P. Iruzubieta, J. Cabezas, A. Giráldez Gallego, E. del P. Rodríguez Seguel, M. Cuaresma, M. Prieto, I. Conde Amiel, M. Berenguer, M. García‐Eliz, J.M. Moreno, P. Martínez‐Rodenas, M. Garrido, C. Oliva, E. Gómez Domínguez, L. Cabrera, L. Cuevas, M. Bruguera, P. Gines, S. Lens, J.C. García, Z. Mariño, M. Hernández Guerra, M. Moreno San Fiel, C. Boada Fernández del Campo, J. Fuentes Olmo, E.M. Fernández Bonilla, F. Jorquera, and J. González Gallego

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Hígado - Enfermedades, Comorbidity, elderly, Severity of Illness Index, 030226 pharmacology & pharmacy, Culprit, oldest-old, Young Adult, 03 medical and health sciences, Liver disease, Sex Factors, 0302 clinical medicine, Levofloxacin, Internal medicine, medicine, Humans, Pharmacology (medical), Ticlopidine, Child, Aged, Aged, 80 and over, Pharmacology, Polypharmacy, business.industry, Age Factors, Odds ratio, Middle Aged, Jaundice, medicine.disease, mortality, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Spain, 030220 oncology & carcinogenesis, comorbitity, Female, Chemical and Drug Induced Liver Injury, medicine.symptom, business, drug-induced liver injury, Cholestatic, medicine.drug
Abstract

Old patients with hepatotoxicity have been scarcely studied in idiosyncratic drug-induced liver injury (DILI) cohorts. We sought for the distinctive characteristics of DILI in older patients across age groups. A total of 882 DILI patients included in the Spanish DILI Registry (33% ≥65 years) were categorized according to age: “young” (

Published
2020
Full Text
View/download PDF

3. Comprehensive analysis and insights gained from long-term experience of the Spanish DILI registry

Author

Hao Niu, José M. González, R. Quiles, S. Lorenzo, Antonio Madejón, Sabela Lens, J. Pinazo, Eduardo Vilar, F.J. Esandi, A.M. Barriocanal, L. Cuevas, Raúl J. Andrade, G. Soriano, P. Martínez Odriozola, E. del P. Rodríguez Seguel, J.C. Titos Arcos, Zoe Mariño, J.A. Del Campo, E. García Oltra, J. García Samaniego, Isabel Conde, C. Boada Fernández del Campo, Germán Soriano, J.M. Moreno Sanfiel, A. de Juan Gómez, G. Pelaez, J.M. Pérez-Moreno, José Luis Montero, Rosa Maria Morillas, A. Hernández, S. Blanco, A. Ocaña, Maria Sala, Judith Sanabria-Cabrera, I. Santaella, J. Sánchez Delgado, H. Hallal, J. Miguel Moreno-Sanfiel, A. Gómez García, J.M. Egea Caparrós, M. Fernández Gil, C. Stephens, R. Calle-Sanz, Eva Román, A. Gila, E. Gómez Domínguez, B. Fombuena, Álvaro Giráldez, A. Ortega-Alonso, Ángela Rojas, A. Papineau, Pedro Otazua, Rocio Sanjuan-Jimenez, R. Millán-Domínguez, María Cuaresma, I. Álvarez-Álvarez, Joaquín Cabezas, José María Moreno-Planas, J.L. Cabriada, A. Giráldez Gallego, Martín Prieto, J. Sanabria-Cabrera, Inmaculada Medina-Caliz, E. Zapata, E. Montané, Joaquín Arenas, M. Jiménez Pérez, P. Martínez-Rodenas, Miren García-Cortés, B. García Muñoz, M. González Sánchez, Javier Ampuero, M.C. Fernandez, E. del Campo, Carlos Guarner, Miguel Jiménez-Pérez, M. Isabel Lucena, M. Prieto, Jose Luis Calleja, P. Rendon, A. Gil Gómez, E.M. Fernández Bonilla, I. Conde Amiel, Javier Crespo, Ana Lucía Arellano, J.R. Molés, César Fernández, Miguel A. Casado, M. Vergara Gómez, M. García Cortes, P. Palomino, Aida Ortega-Alonso, M. Carmen Fernández, Manuel Romero-Gómez, M. Romero-Gómez, J. González Gallego, Elvira Bonilla, A. Castiella, María García-Eliz, Marta Tejedor, M.A. Quijada Manuitt, J.M. Moreno, M.I. Lucena, J. Fuentes Olmo, E.M. Román, Agustin Castiella, A. Garayoa, I. Medina-Cáliz, Mahmoud Slim, M. Hernandez Guerra, R. Alcantara, C. Sánchez Cobarro, Marina Berenguer, J.L. Martínez Porras, Pere Ginès, J.C. García, A. Porcel, Neil Kaplowitz, Ismael Alvarez-Alvarez, D. Di Zeo, JM Salmerón, R.J. Andrade, A. González-Jiménez, A. Pérez Martínez, C. Lara, H. Masnou Ridaura, Miquel Bruguera, R. González Grande, A. Cueto, M. Villanueva, Marta Casado, J. Primo, S. López Ortega, Paula Iruzubieta, M. Carrascosa, Rocío Gallego, M. Garrido, Liliana Rendón Rojas, S. Sánchez Campos, M. Robles-Díaz, R.M. Antonijoan Arbos, Mercedes Robles-Díaz, F. Jorquera, C. Oliva, Camilla Stephens, M.D. García Escaño, M. de la Mata, Yolanda Sanz, R. González Ferrer, Magí Farré, Rocío González-Grande, Instituto de Salud Carlos III, European Commission, Agencia Española de Medicamentos y Productos Sanitarios, Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (España), and Junta de Andalucía

Subjects
0301 basic medicine, Male, Epidemiology, Autoimmune hepatitis, Hepatitis, Liver disease, 0302 clinical medicine, Anti-Infective Agents, Liver Function Tests, Causative agents, Risk Factors, Risk of mortality, Registries, Outcome, Liver injury, Liver Diseases, Age Factors, Middle Aged, Prognosis, 030211 gastroenterology & hepatology, DILI, Female, Chemical and Drug Induced Liver Injury, medicine.medical_specialty, Liver-related death, DILI, Hepatotoxicity, causative agents, drug-induced autoimmune hepatitis, epidemiology, liver-related death, outcome, risk factors, therapy in DILI, Risk Assessment, 03 medical and health sciences, Internal medicine, medicine, Epidemiología, Humans, Aspartate Aminotransferases, Mortality, Drug-induced autoimmune hepatitis, Hepatology, business.industry, Platelet Count, Hepatotoxicity, Odds ratio, medicine.disease, Comorbidity, Liver Transplantation, Transplantation, 030104 developmental biology, Risk factors, Spain, Chronic Disease, business, Therapy in DILI
Abstract

[Background & Aims] Prospective drug-induced liver injury (DILI) registries are important sources of information on idiosyncratic DILI. We aimed to present a comprehensive analysis of 843 patients with DILI enrolled into the Spanish DILI Registry over a 20-year time period., [Methods] Cases were identified, diagnosed and followed prospectively. Clinical features, drug information and outcome data were collected., [Results] A total of 843 patients, with a mean age of 54 years (48% females), were enrolled up to 2018. Hepatocellular injury was associated with younger age (adjusted odds ratio [aOR] per year 0.983; 95% CI 0.974–0.991) and lower platelet count (aOR per unit 0.996; 95% CI 0.994–0.998). Anti-infectives were the most common causative drug class (40%). Liver-related mortality was more frequent in patients with hepatocellular damage aged ≥65 years (p = 0.0083) and in patients with underlying liver disease (p = 0.0221). Independent predictors of liver-related death/transplantation included nR-based hepatocellular injury, female sex, higher onset aspartate aminotransferase (AST) and bilirubin values. nR-based hepatocellular injury was not associated with 6-month overall mortality, for which comorbidity burden played a more important role. The prognostic capacity of Hy’s law varied between causative agents. Empirical therapy (corticosteroids, ursodeoxycholic acid and MARS) was prescribed to 20% of patients. Drug-induced autoimmune hepatitis patients (26 cases) were mainly females (62%) with hepatocellular damage (92%), who more frequently received immunosuppressive therapy (58%)., [Conclusions] AST elevation at onset is a strong predictor of poor outcome and should be routinely assessed in DILI evaluation. Mortality is higher in older patients with hepatocellular damage and patients with underlying hepatic conditions. The Spanish DILI Registry is a valuable tool in the identification of causative drugs, clinical signatures and prognostic risk factors in DILI and can aid physicians in DILI characterisation and management., [Lay summary] Clinical information on drug-induced liver injury (DILI) collected from enrolled patients in the Spanish DILI Registry can guide physicians in the decision-making process. We have found that older patients with hepatocellular type liver injury and patients with additional liver conditions are at a higher risk of mortality. The type of liver injury, patient sex and analytical values of aspartate aminotransferase and total bilirubin can also help predict clinical outcomes., The present study has been supported by grants of Instituto de Salud Carlos III cofounded by Fondo Europeo de Desarrollo Regional – FEDER (contract numbers: PI19/00883, PI16/01748, PI18/00901, PI18/01804, PI-0285-2016, PI-0274-2016, PI-0310-2018, PT17/0017/0020) and Agencia Española del Medicamento. CIBERehd and Plataforma ISCIII Ensayos Clinicos are funded by Instituto de Salud Carlos III. MRD holds a Joan Rodes (JR16/00015)/Acción B clinicos investigadores (B-0002-2019) and JSC a Rio Hortega (CM17/00243) research contract from ISCIII and Consejería de Salud de Andalucía.

Published
2021

4. Distinct phenotype of hepatotoxicity associated with illicit use of anabolic androgenic steroids

Author

B. García-Muñoz, P. Rendón, Raymundo Paraná, J.M. Navarro, E. Blanco‐Reina, Aida Ortega-Alonso, J.R. Brahm, Raúl J. Andrade, María Isabel Lucena, Mercedes Robles-Díaz, Camilla Stephens, Pere Ginès, A. González-Jiménez, Fernando Bessone, Martín Prieto, Miguel Jiménez-Pérez, Inmaculada Medina-Caliz, M. García-Eliz, Miren García-Cortés, and Rocío González-Grande

Subjects
Adult, Male, Drug, medicine.medical_specialty, Bilirubin, media_common.quotation_subject, Jaundice, Logistic regression, Gastroenterology, Young Adult, chemistry.chemical_compound, Anabolic Agents, Risk Factors, Internal medicine, medicine, Humans, Pharmacology (medical), Aged, media_common, Creatinine, Cholestasis, Hepatology, business.industry, Acute kidney injury, Acute Kidney Injury, Middle Aged, medicine.disease, Anabolic-Androgenic Steroids, Phenotype, Surgery, chemistry, Androgens, Chemical and Drug Induced Liver Injury, medicine.symptom, business
Abstract

Summary Background We have observed an increase in hepatotoxicity (DILI) reporting related to the use of anabolic androgenic steroids (AAS) for bodybuilding. Aim To characterise phenotype presentation, outcome and severity of AAS DILI. Methods Data on 25 cases of AAS DILI reported to the Spanish (20) and Latin-American (5) DILI Registries were collated and compared with previously published cases. Results AAS DILI increased from representing less than 1% of the total cases in the Spanish DILI Registry in the period 2001–2009 to 8% in 2010–2013. Young men (mean age 32 years), requiring hospitalisation, hepatocellular injury and jaundice were predominating features among the AAS cases. AAS DILI caused significantly higher bilirubin values independent of type of damage when compared to other drug classes (P = 0.001). Furthermore, the cholestatic AAS cases presented significantly higher mean peak bilirubin (P = 0.029) and serum creatinine values (P = 0.0002), compared to the hepatocellular cases. In a logistic regression model, the interaction between peak bilirubin values and cholestatic damage was associated with the development of AAS-induced acute kidney impairment (AKI) [OR 1.26 (95% CI: 1.035–1.526); P = 0.021], with 21.5 ×ULN being the best bilirubin cut-off point for predicting AKI risk (AUCROC 0.92). No fatalities occurred. Conclusions Illicit recreational AAS use is a growing cause of reported DILI that can lead to severe hepatic and renal injury. AAS DILI is associated with a distinct phenotype, characterised by considerable bilirubin elevations independent of type of damage. Although hepatocellular injury predominates, acute kidney injury develops in cholestatic cases with pronounced jaundice.

Published
2014
Full Text
View/download PDF

5. Idiosyncratic Drug-Induced Liver Injury: A 20-Year Update of the Cases Enrolled by the Spanish dili Registry

Author

Germán Soriano, J.M. Navarro, R. María Morillas, E. Zapata, E. Montané, Mercedes Robles-Díaz, J. Sanabria, Ana Aldea, Raúl J. Andrade, Isabel Conde, B. García-Muñoz, Mahmoud Slim, Agustin Castiella, S. Blanco, Miren García-Cortés, Martín Prieto, A. Ortega, Manuel Hernández-Guerra, Pere Ginès, M.C. Fernandez, Eva Román, Manuel Romero-Gómez, Inmaculada Medina-Caliz, Rocio Sanjuan-Jimenez, A. González-Jiménez, Elena Gómez-Domínguez, M. Jiménez, M.I. Lucena, J.M. Moreno, and H. Hallal

Subjects
Pharmacology, Drug, Liver injury, Pediatrics, medicine.medical_specialty, business.industry, media_common.quotation_subject, Medicine, Pharmacology (medical), business, medicine.disease, media_common
Published
2017

6. Clinical characteristics and outcomes of elderly included in the Spanish Drug-Induced Liver Injury (DILI) Registry

Author

B. García-Muñoz, Manuel Romero-Gómez, Eva Román, M.C. Fernandez, A. Ortega, M.I. Lucena, Isabel Conde, Manuel Hernández-Guerra, J.M. Moreno, R.J. Andrade, M. Jiménez, Mahmoud Slim, J.M. Navarro, Inmaculada Medina-Caliz, M. García-Cortés, Agustin Castiella, Martín Prieto, Rocio Sanjuan-Jimenez, E. Zapata, E. Montané, J. Sanabria, Germán Soriano, H. Hallal, A. González-Jiménez, Ana Aldea, Elena Gómez-Domínguez, and Mercedes Robles-Díaz

Subjects
Drug, Liver injury, medicine.medical_specialty, Hepatology, business.industry, media_common.quotation_subject, Emergency medicine, Physical therapy, Medicine, business, medicine.disease, media_common
Published
2017

7. DRESS cases included in the Spanish and Latin-American DILI registries: clinical phenotype and outcome

Author

B. García-Muñoz, M.I. Lucena, María Cabello, M. Almarza, M. Quiros-Cano, Fernando Bessone, Martín Prieto, Aida Ortega-Alonso, A. González-Jiménez, Pere Ginès, A. Cueto, Inmaculada Medina-Caliz, M.C. Fernandez, Mercedes Robles-Díaz, Miren Garcia Cortes, Germán Soriano, Marco Arrese, Camilla Stephens, Nelia Hernández, M.R. Gomez, Rocio Sanjuan-Jimenez, Judith Sanabria-Cabrera, Raúl J. Andrade, Isabel Conde, and F. Martin-Reyes

Subjects
0301 basic medicine, medicine.medical_specialty, Latin Americans, Hepatology, business.industry, 01 natural sciences, Outcome (game theory), 0104 chemical sciences, 010404 medicinal & biomolecular chemistry, 03 medical and health sciences, 030104 developmental biology, Internal medicine, Medicine, Clinical phenotype, business
Published
2018
Full Text
View/download PDF

8. Drug-Induced Liver Injury: An Analysis of 461 Incidences Submitted to the Spanish Registry Over a 10-Year Period

Author

B. García-Muñoz, M. Carmen Fernández, Luis Rodrigo, G. Pelaez, Manuel Romero-Gómez, J.M. Navarro, Joan Costa, Elena García-Ruiz, Rocío González-Grande, M. Isabel Lucena, Angeles Pizarro, Rafael Martín-Vivaldi, Javier Salmerón, Africa Borras, Ketevan Pachkoria, Raúl J. Andrade, Manuel Jimenez, Ramon Planas, Aina Soler, and José Antonio Durán

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Drug-Related Side Effects and Adverse Reactions, Amoxicillin-Potassium Clavulanate Combination, Risk Assessment, Hy's law, Age Distribution, Fulminant hepatic failure, Internal medicine, Odds Ratio, medicine, Humans, Registries, Sex Distribution, Survival analysis, Aged, Probability, Proportional Hazards Models, Retrospective Studies, Aged, 80 and over, Analysis of Variance, Hepatology, Proportional hazards model, business.industry, Incidence, Liver Diseases, Incidence (epidemiology), Gastroenterology, Retrospective cohort study, Odds ratio, Middle Aged, Survival Analysis, Anti-Bacterial Agents, Surgery, Transplantation, Liver, Spain, Female, Chemical and Drug Induced Liver Injury, business, Liver Failure
Abstract

Progress in the understanding of susceptibility factors to drug-induced liver injury (DILI) and outcome predictability are hampered by the lack of systematic programs to detect bona fide cases.A cooperative network was created in 1994 in Spain to identify all suspicions of DILI following a prospective structured report form. The liver damage was characterized according to hepatocellular, cholestatic, and mixed laboratory criteria and to histologic criteria when available. Further evaluation of causality assessment was centrally performed.Since April 1994 to August 2004, 461 out of 570 submitted cases, involving 505 drugs, were deemed to be related to DILI. The antiinfective group of drugs was the more frequently incriminated, amoxicillin-clavulanate accounting for the 12.8% of the whole series. The hepatocellular pattern of damage was the most common (58%), was inversely correlated with age (P.0001), and had the worst outcome (Cox regression, P.034). Indeed, the incidence of liver transplantation and death in this group was 11.7% if patients had jaundice at presentation, whereas the corresponding figure was 3.8% in nonjaundiced patients (P.04). Factors associated with the development of fulminant hepatic failure were female sex (OR = 25; 95% CI: 4.1-151; P.0001), hepatocellular damage (OR = 7.9; 95% CI: 1.6-37; P.009), and higher baseline plasma bilirubin value (OR = 1.15; 95% CI: 1.09-1.22; P.0001).Patients with drug-induced hepatocellular jaundice have 11.7% chance of progressing to death or transplantation. Amoxicillin-clavulanate stands out as the most common drug related to DILI.

Published
2005
Full Text
View/download PDF

9. Hepatotoxicity Associated with Non-Steroidal Anti-Inflammatory Drugs. A Comparative Analysis among Ibuprofen, Diclofenac and Nimesulide fromthe Spanish and Latin-American Dili Registries

Author

Judith Sanabria-Cabrera, Aida Ortega-Alonso, M.I. Lucena, M. García-Cortés, Mercedes Robles-Díaz, R.J. Andrade, Miguel Eugenio Zoubek, Nelia Hernández, Manuel Romero-Gómez, B. García-Muñoz, A. González-Jiménez, P. Díaz-Jimenez, Mahmoud Slim, M.C. Fernandez, Marco Arrese, Inmaculada Medina-Caliz, E. Montané, Rocio Sanjuan-Jimenez, María Cabello, H. Hallal, and Fernando Bessone

Subjects
Diclofenac, Hepatology, Non steroidal anti inflammatory, business.industry, medicine, Pharmacology, Ibuprofen, business, Nimesulide, medicine.drug
Published
2016
Full Text
View/download PDF

10. Metabolic risk factors affect clinical Phenotype and outcome of Hepatotoxicity (DILI)

Author

A. González-Jiménez, B. García-Muñoz, E.M. Zapata, María Isabel Lucena, Marco Arrese, Miren García-Cortés, José María Moreno-Planas, Manuel Romero-Gómez, Mercedes Robles-Díaz, Aida Ortega-Alonso, I. Medina-Cáliz, Germán Soriano, Camilla Stephens, Agustin Castiella, H. Hallal, A. Ruíz, J.M. Navarro, M.C. Fernandez, S. Blanco, Fernando Bessone, Nelia Hernández, Judith Sanabria-Cabrera, Eva Román, A. Aldea, M. Jiménez, and Raúl J. Andrade

Subjects
Pharmacology, business.industry, Metabolic risk, Medicine, Pharmacology (medical), business, Clinical phenotype, Bioinformatics, Affect (psychology), Outcome (game theory)
Published
2015
Full Text
View/download PDF

11. Distinguishing Drug-induced Autoimmune Hepatitis from idiopatic Autoimmune Hepatitis and Dili with Autoantibodies

Author

José María Moreno-Planas, Martín Prieto, Raúl J. Andrade, Agustin Castiella, Nelia Hernández, S. Blanco, M.I. Lucena, J. Sanabria, E. Zapata, B. García-Muñoz, Marco Arrese, M.C. Fernandez, Pedro Otazua, Aida Ortega-Alonso, Fernando Bessone, Inmaculada Medina-Caliz, Miren García-Cortés, H. Hallal, J. Primo, Mercedes Robles-Díaz, Camilla Stephens, and A. González-Jiménez

Subjects
Pharmacology, Drug, business.industry, media_common.quotation_subject, Immunology, Autoantibody, Medicine, Pharmacology (medical), Autoimmune hepatitis, business, medicine.disease, media_common
Published
2015
Full Text
View/download PDF

12. P1098 : Influence of metabolic risk factors in hepatotoxicity (DILI) phenotype and outcome

Author

J.M. Navarro, M. Jiménez, Raúl J. Andrade, A. Ruíz, María Isabel Lucena, B. García-Muñoz, Miren García-Cortés, J. Sanabria, A. González-Jiménez, Agustin Castiella, S. Blanco, A. Ortega-Alonso, G. Pelaez, Ana Aldea, Mercedes Robles-Díaz, José María Moreno-Planas, Camilla Stephens, Germán Soriano, Marco Arrese, Manuel Romero-Gómez, Nelia Hernández, Eva Román, E. Zapata, H. Hallal, Fernando Bessone, and I. Medina-Cáliz

Subjects
Hepatology, business.industry, Metabolic risk, Medicine, Bioinformatics, business, Phenotype, Outcome (game theory)
Published
2015
Full Text
View/download PDF

13. Hepatotoxicity related to Herbals and Dietary Supplements (HDS): a cause for concern

Author

Mercedes Robles-Díaz, B. García-Muñoz, Camilla Stephens, M. García-Eliz, Raúl J. Andrade, Miren García-Cortés, Enrique Carrera, Fernando Bessone, Aida Ortega-Alonso, Judith Sanabria-Cabrera, M.I. Lucena, Inmaculada Medina-Caliz, E. Blanco, B. Thorpe, A.M. Barriocanal, S. Mirwani, A. González-Jiménez, Edgardo Mengual, J.M. Navarro, M.C. Fernandez, Nelia Hernández, E. Montané, Martín Prieto, Miguel Jiménez-Pérez, I. Bellido, and M.R. Montes

Subjects
Pharmacology, Drug, Diplopia, medicine.medical_specialty, genetic structures, business.industry, media_common.quotation_subject, Visual impairment, Alternative medicine, Pharmacy, eye diseases, Clinical Practice, Blurred vision, Emergency medicine, medicine, Pharmacology (medical), medicine.symptom, Adverse effect, business, media_common
Abstract

August 2015 e123 Assessment and Drug Research, Coimbra, Portugal; and University of Coimbra, School of Pharmacy, Coimbra, Portugal Background: Drugs either used in the treatment of ocular or systemic pathologic conditions have the potential to cause adverse events in the eye and to affect ocular functions. Ocular adverse events are the fewest adverse events studied and assessed in post-marketing surveillance. The investigation of the regulatory actions resulting from the identification of serious ocular disorders associated with the use of drugs, irrespective of being locally or systemically administered, during the last decade, is of utmost importance given its implication for the clinical practice. Material and Methods: The websites of four health regulatory authorities were reviewed to identify safety alerts issued on ocular adverse events. Safety alerts were included if they have been issued between January 2005 and December 2014. Only safety alerts on drugs with market authorization were considered for inclusion. Results: Thirty-eight safety alerts were included in the study. “Urologicals” (n = 11; 29%), followed by “Drugs used in diabetes”, “Antibacterials for systemic use”, “Antioneplastic agents”, and “Ophthalmologicals” were the most frequent suspected drugs evaluated in the safety alerts (n = 4; 10%, each). The most frequently evaluated adverse events were “Visual disorders NEC” (n = 12; 32%), including visual impairment, diplopia, and blurred vision. The majority (n = 25; 66%) of the safety alerts were supported by postmarketing spontaneous reports. The most commonly updated drug label section was the “Warnings and Precautions” section (n = 33; 87%), followed by the “Adverse reactions” section (n = 26; 68%). Conclusion: Ocular adverse events newly identified during this decade come mostly from systemic drugs, some of them marketed for several years. Physicians should be aware of drug-induced adverse effects in the eye in order to avoid as soon as possible their progression, which can lead to visual impairment.

Published
2015
Full Text
View/download PDF

14. P310 ANABOLIC ANDROGENIC STEROIDS (AAS) ILLICIT USE IS A RAPIDLY GROWING CAUSE OF DRUG-INDUCED LIVER INJURY (DILI): A PROSPECTIVE SERIES FROM THE SPANISH–LATIN-AMERICAN DILI REGISTRY

Author

Raymundo Paraná, A. González-Jiménez, J.R. Brahm, P. Rendón, J.M. Navarro, Maria Isabel Schinoni, I.M. Méndez, Fernando Bessone, I. Alfaro, Inmaculada Medina-Caliz, Rocío González-Grande, Manuel Romero-Gómez, M. García-Eliz, B. García-Muñoz, Pere Ginès, M. García-Cortés, A.F. González-Ramirez, Mercedes Robles-Díaz, R. Calle-Sanz, A. Crespillo, Camilla Stephens, R.J. Andrade, R. Alcantara, M. Prieto, María Cabello, M. Jiménez, and M.I. Lucena

Subjects
Drug, Liver injury, Latin Americans, Hepatology, business.industry, media_common.quotation_subject, medicine, Physiology, Pharmacology, medicine.disease, Anabolic-Androgenic Steroids, business, media_common
Published
2014
Full Text
View/download PDF

15. 486 IDIOSYNCRATIC DRUG-INDUCED LIVER INJURY (DILI) IN PATIENTS WITH PRE-EXISTING LIVER DISEASE: AN ANALYSIS OF THE CASES INCLUDED IN THE SPANISH DILI REGISTRY

Author

M.I. Lucena, S. Ávila, Agustin Castiella, N. Ortiz López, Ramón Pérez-Álvarez, B. García-Muñoz, M.C. Fernandez, M. Roble, R.J. Andrade, Y. Borraz, and S. Blanco

Subjects
Drug, Liver injury, medicine.medical_specialty, Hepatology, business.industry, media_common.quotation_subject, medicine.disease, Gastroenterology, Liver disease, Internal medicine, medicine, In patient, business, media_common
Published
2011
Full Text
View/download PDF

16. 896 THE NATURAL HISTORY OF IDIOSYNCRATIC DRUG-INDUCED LIVER INJURY (DILI): FOLLOW-UP IN A COHORT OF PATIENTS IDENTIFIED IN A SINGLE TERTIARY CARE CENTRE

Author

M.I. Lucena, M.C. Lopez-Vega, B. García-Muñoz, N. Ortiz, Mercedes Robles, A. Fernandez Castaner, R.J. Andrade, Y. Borraz, Susana Lopez-Ortega, and I. Cueto

Subjects
Liver injury, Drug, medicine.medical_specialty, Hepatology, business.industry, media_common.quotation_subject, medicine.disease, Tertiary care, Surgery, Natural history, Internal medicine, Cohort, medicine, business, media_common
Published
2008
Full Text
View/download PDF

17. 669 Chronic liver damage after an episode of idiosyncratic drug induced liver injury (DILI)

Author

M. García-Cortés, Ramon Planas, Manuel Romero-Gómez, B. García-Muñoz, Carlos Guarner, Y. Borraz, M.I. Lucena, Ketevan Pachkoria, Aina Soler, José Antonio Durán, M.C. Fernandez, T. Muñoz-Yagüe, R.J. Andrade, Neil Kaplowitz, G. Pelaez, and Luis Rodrigo

Subjects
Drug, Liver injury, medicine.medical_specialty, Hepatology, business.industry, media_common.quotation_subject, Internal medicine, Medicine, Liver damage, business, medicine.disease, Gastroenterology, media_common
Published
2006
Full Text
View/download PDF

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

Author

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, and Andrade RJ

Subjects
Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Child, Female, Humans, Male, Middle Aged, Risk Factors, Sex Factors, Spain epidemiology, Young Adult, Chemical and Drug Induced Liver Injury epidemiology, Chemical and Drug Induced Liver Injury pathology, Dietary Supplements adverse effects, Drugs, Chinese Herbal adverse effects
Abstract

Background & Aims: 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., Methods: 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., Results: 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., Conclusion: 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.)

Published
2018
Full Text
View/download PDF

19. Prolonged cholestasis after raloxifene and fenofibrate interaction: A case report.

Author

Lucena MI, Andrade RJ, Vicioso L, González FJ, Pachkoria K, and García-Muñoz B

Subjects
Biopsy, Female, Humans, Middle Aged, Cholestasis chemically induced, Cholestasis diagnosis, Fenofibrate pharmacology, Hypolipidemic Agents pharmacology, Liver drug effects, Raloxifene Hydrochloride pharmacology, Selective Estrogen Receptor Modulators pharmacology
Abstract

Assigning causality in drug-induced liver injury is challenging particularly when more than one drug could be responsible. We report a woman on long-term therapy with raloxifen who developed acute cholestasis shortly after starting fenofibrate. The picture evolved into chronic cholestasis. We hypothesized that an interaction at the metabolic level could have triggered the presentation of hepatotoxicity after a very short time of exposure to fenofibrate in this patient. The findings of an overexpression of vascular endothelial growth factor in the liver biopsy suggest that angiogenesis might play a role in the persistence of toxic cholestasis.

Published
2006
Full Text
View/download PDF

20. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period.

Author

Andrade RJ, Lucena MI, Fernández MC, Pelaez G, Pachkoria K, García-Ruiz E, García-Muñoz B, González-Grande R, Pizarro A, Durán JA, Jiménez M, Rodrigo L, Romero-Gomez M, Navarro JM, Planas R, Costa J, Borras A, Soler A, Salmerón J, and Martin-Vivaldi R

Subjects
Adolescent, Adult, Age Distribution, Aged, Aged, 80 and over, Amoxicillin-Potassium Clavulanate Combination therapeutic use, Analysis of Variance, Anti-Bacterial Agents adverse effects, Anti-Bacterial Agents therapeutic use, Female, Humans, Incidence, Liver Diseases epidemiology, Liver Failure chemically induced, Liver Failure epidemiology, Male, Middle Aged, Odds Ratio, Probability, Proportional Hazards Models, Registries, Retrospective Studies, Risk Assessment, Sex Distribution, Spain epidemiology, Survival Analysis, Amoxicillin-Potassium Clavulanate Combination adverse effects, Chemical and Drug Induced Liver Injury, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions etiology, Liver drug effects
Abstract

Background & Aims: Progress in the understanding of susceptibility factors to drug-induced liver injury (DILI) and outcome predictability are hampered by the lack of systematic programs to detect bona fide cases., Methods: A cooperative network was created in 1994 in Spain to identify all suspicions of DILI following a prospective structured report form. The liver damage was characterized according to hepatocellular, cholestatic, and mixed laboratory criteria and to histologic criteria when available. Further evaluation of causality assessment was centrally performed., Results: Since April 1994 to August 2004, 461 out of 570 submitted cases, involving 505 drugs, were deemed to be related to DILI. The antiinfective group of drugs was the more frequently incriminated, amoxicillin-clavulanate accounting for the 12.8% of the whole series. The hepatocellular pattern of damage was the most common (58%), was inversely correlated with age (P < .0001), and had the worst outcome (Cox regression, P < .034). Indeed, the incidence of liver transplantation and death in this group was 11.7% if patients had jaundice at presentation, whereas the corresponding figure was 3.8% in nonjaundiced patients (P < .04). Factors associated with the development of fulminant hepatic failure were female sex (OR = 25; 95% CI: 4.1-151; P < .0001), hepatocellular damage (OR = 7.9; 95% CI: 1.6-37; P < .009), and higher baseline plasma bilirubin value (OR = 1.15; 95% CI: 1.09-1.22; P < .0001)., Conclusions: Patients with drug-induced hepatocellular jaundice have 11.7% chance of progressing to death or transplantation. Amoxicillin-clavulanate stands out as the most common drug related to DILI.

Published
2005
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results