Safety of gadoxetate disodium: Results from the clinical phase II-III development program and postmarketing surveillance

• Published in: Journal of magnetic resonance imaging 2015-09, Vol.42 (3), p.634-643
• Main Authors: Endrikat, Jan S., Dohanish, Susan, Balzer, Thomas, Breuer, Josy A.M.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged, 80 and over; Body Weight; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Contrast Media - adverse effects; Contrast Media - therapeutic use; Female; Gadolinium DTPA - adverse effects; Gadolinium DTPA - therapeutic use; gadoxetate disodium; Humans; Liver; Liver - drug effects; Liver - pathology; Liver Diseases - pathology; liver MR imaging; Liver Neoplasms - pathology; Magnetic Resonance Imaging; Male; Middle Aged; NMR; Nuclear magnetic resonance; Patient Safety; Pharmaceutical industry; Product Surveillance, Postmarketing; safety; Surveillance; Young Adult
• ISSN: 1053-1807; 1522-2586
• DOI: 10.1002/jmri.24838

Purpose To summarize the safety data of gadoxetate disodium, reported in 12 Phase II and III clinical development studies and in the postmarketing surveillance database. Materials and Methods Patients with liver lesions received gadoxetate disodium‐enhanced liver magnetic resonance imaging (MRI). Adverse events (AEs) were recorded and evaluated with regard to a potential drug relationship. Subgroup analyses were run on patients with special medical history. Worldwide spontaneous AEs and adverse drug reactions (ADRs) from postmarketing safety surveillance were analyzed. Results A total of 1989 patients were included in the clinical development program. A total of 1581/1989 (79.5%) patients received the finally approved dose of 0.025 mmol/kg body weight. 10.1% of patients reported AEs, 4.1% were classified as related AEs. Nausea and headache were the most frequently reported related AEs, with 1.1% each. Age, history of contrast media allergy, liver cirrhosis, or impaired liver or renal function did not significantly impact the frequency and type of AEs. The postmarketing safety surveillance database encompassed more than 2.2 million patients. Nausea was the most frequent ADR, with a reporting rate of 0.00652%; all other symptoms were below 0.004%. Conclusion Gadoxetate disodium for liver MRI has an excellent safety profile. J. Magn. Reson. Imaging 2015;42:634–643.