Safety assessment of gadobenate dimeglumine (MultiHance®): Extended clinical experience from phase I studies to post-marketing surveillance
✍ Scribed by Miles A. Kirchin; Gianpaolo Pirovano; Carol Venetianer; Alberto Spinazzi
- Publisher
- John Wiley and Sons
- Year
- 2001
- Tongue
- English
- Weight
- 116 KB
- Volume
- 14
- Category
- Article
- ISSN
- 1053-1807
No coin nor oath required. For personal study only.
✦ Synopsis
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.