title: Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients.
abstract: Background Safety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet. Purpose To assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting. Material and Methods Six multicenter studies were performed in Europe, USA, Australia, and Asia to evaluate the safety and efficacy of gadoxetate disodium (Primovist®/Eovist®) enhanced liver MRI. Patients received a single intravenous bolus injection of the standard approved dose of 0.025 mmol/kg body weight (0.1 mL/kg). The number of patients, the characteristics of adverse events, related adverse events, and serious adverse events were analyzed. Results A total of 8194 patients were included in the database. A total of 141 patients (1.7%) reported 230 AEs of which 129 were considered being related to the use of gadoxetate disodium by the investigators. None of the AEs in the pediatric population ( n = 52) were related. The most frequent AEs independent of relationship to the drug included dyspnea (25/0.31%), nausea (22/0.27%), liver disorders (13/0.16%), and renal disorders (9/0.11%). Nine related SAEs were recorded. No patient died during the studies. Conclusion Gadoxetate disodium for liver MRI is safe and well tolerated in the routine clinical setting.
authors.affiliation: 1 Bayer HealthCare Pharmaceuticals, Medical Care, Radiology & Interventional, Berlin, Germany.|2 Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
authors.affiliation: 3 University of Ulsan College of Medicine, Asan Medical Center, Department of Radiology, Seoul, Republic of Korea.
authors.forename: So Yeon
authors.initials: SY
authors.lastname: Kim
authors.affiliation: 4 Bayer Yakuhin, Ltd., Medical Affairs Pharmacovigilance, Osaka, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Sakaguchi
authors.affiliation: 5 Bayer HealthCare Pharmaceuticals, Global Pharmacovigilance and Risk Management, Whippany, NJ, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Dohanish
authors.affiliation: 1 Bayer HealthCare Pharmaceuticals, Medical Care, Radiology & Interventional, Berlin, Germany.
authors.forename: Josy
authors.initials: J
authors.lastname: Breuer
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D004417:Dyspnea / Q000453:epidemiology; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D038622:Internationality; D007674:Kidney Diseases / Q000453:epidemiology; D008107:Liver Diseases / Q000000981:diagnostic imaging* / Q000453:epidemiology; D008279:Magnetic Resonance Imaging / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000453:epidemiology; D015995:Prevalence; D012307:Risk Factors; D017678:Sex Distribution; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA
keywords: Gadoxetate disodium; liver; magnetic resonance imaging (MRI); safety