Rivaroxaban postmarketing risk of liver injury
| Autor: | Stefan Russmann, Caroline Schmidt, Gerd A. Kullak-Ublick, Bruno Stieger, Sandra Hürlimann, David Niedrig, Mathias Budmiger |
|---|---|
| Přispěvatelé: | University of Zurich, Russmann, Stefan |
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Risk medicine.medical_specialty Morpholines 610 Medicine & health Thiophenes 030204 cardiovascular system & hematology 03 medical and health sciences Liver disease 0302 clinical medicine Rivaroxaban U6 Integrative Human Physiology Internal medicine Pharmacovigilance Product Surveillance Postmarketing medicine Humans Adverse effect Aged Aged 80 and over Liver injury Hepatology medicine.diagnostic_test business.industry Middle Aged medicine.disease 3. Good health 10199 Clinic for Clinical Pharmacology and Toxicology Anesthesia Liver biopsy Relative risk 2721 Hepatology Female 030211 gastroenterology & hepatology Chemical and Drug Induced Liver Injury business Adverse drug reaction Factor Xa Inhibitors medicine.drug |
| Zdroj: | Journal of Hepatology |
| ISSN: | 0168-8278 |
| DOI: | 10.1016/j.jhep.2014.03.026 |
| Popis: | Background & Aims Rivaroxaban is an oral direct factor Xa inhibitor that has been marketed worldwide since 2008 for the primary and secondary prevention and treatment of thromboembolic disorders. Although liver injury was observed in premarketing trials of rivaroxaban, there are no published postmarketing cases of liver injury associated with rivaroxaban. Methods Report of 14 cases of liver injury associated with rivaroxaban, including two with liver biopsy, and search queries in three large international pharmacovigilance databases for comparable cases. Results Formal causality assessment classified rivaroxaban as the "highly probable", "probable", and "possible" cause in 4, 7, and 3 patients, respectively. Search results from three large international pharmacovigilance databases revealed a considerable number of additional hepatic adverse events where rivaroxaban was reported as a suspected cause. Conclusions We interpret the presented information as a relevant safety signal that should be followed by pharmacoepidemiological studies in order to reliably estimate absolute and relative risks of liver injury associated with rivaroxaban in support of rational risk-benefit assessment. Meanwhile, incident symptoms and signs of liver disease in patients treated with rivaroxaban should be considered as a potential adverse drug reaction, and if no other likely cause can be identified rivaroxaban should be stopped as soon as possible. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect