Safety assessment of gadobenate dimeglumine (MultiHance®): Extended clinical experience from phase I studies to post-marketing surveillance

• Published in: Journal of magnetic resonance imaging 2001-09, Vol.14 (3), p.281-294
• Main Authors: Kirchin, Miles A., Pirovano, Gianpaolo, Venetianer, Carol, Spinazzi, Alberto
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Blood Pressure - drug effects; Contrast Media - adverse effects; Electrocardiography - drug effects; Female; gadobenate dimeglumine; Gd-BOPTA/Dimeg; Humans; Magnetic Resonance Imaging; Male; Meglumine - adverse effects; Meglumine - analogs & derivatives; Middle Aged; MR contrast media; MR imaging; Organometallic Compounds - adverse effects; Product Surveillance, Postmarketing - statistics & numerical data; Safety Management; safety of MR contrast media
• ISSN: 1053-1807; 1522-2586
• DOI: 10.1002/jmri.1184

Clinical trials completed by September 2000 on gadobenate dimeglumine (Gd‐BOPTA; MultiHance®) included 2540 adult and pediatric subjects that were administered this agent. For adult patient volunteers, the overall incidence of adverse events (AEs) was 19.8%, although marked study‐ and indication‐related differences were apparent. Events potentially related to Gd‐BOPTA administration were reported for 15.1% of adult patients. The vast majority of AEs were non‐serious, mild, transient, and self‐resolving. Headache, injection site reaction, nausea, taste perversion, and vasodilation were the most common AEs, reported with a frequency of between 1.0% and 2.6%. Serious AEs potentially related to Gd‐BOPTA were reported for five (0.2%) patients overall. Controlled studies revealed no differences between Gd‐BOPTA and other gadolinium chelates or placebo in the incidence and type of AEs. Similarly, no differences with respect to adult patients and/or comparator were noted in studies on pediatric subjects and subjects with renal or liver insufficiency. Post‐marketing surveillance of approximately 100000 doses revealed an overall AE incidence of < 0.03% with serious AEs reported for < 0.005% of patients. J. Magn. Reson. Imaging 2001;14:281–294. © 2001 Wiley‐Liss, Inc.