PMID- 11536405
OWN - NLM
STAT- MEDLINE
DCOM- 20010913
LR  - 20190915
IS  - 1053-1807 (Print)
IS  - 1053-1807 (Linking)
VI  - 14
IP  - 3
DP  - 2001 Sep
TI  - Safety assessment of gadobenate dimeglumine (MultiHance): extended clinical 
      experience from phase I studies to post-marketing surveillance.
PG  - 281-94
AB  - 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.
CI  - Copyright 2001 Wiley-Liss, Inc.
FAU - Kirchin, M A
AU  - Kirchin MA
AD  - Medical Affairs Europe, Bracco Imaging SpA, Via E Folli 50, 20134 Milan, Italy. 
      mkirchin@bracco.it
FAU - Pirovano, G
AU  - Pirovano G
FAU - Venetianer, C
AU  - Venetianer C
FAU - Spinazzi, A
AU  - Spinazzi A
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Journal Article
PL  - United States
TA  - J Magn Reson Imaging
JT  - Journal of magnetic resonance imaging : JMRI
JID - 9105850
RN  - 0 (Contrast Media)
RN  - 0 (Organometallic Compounds)
RN  - 15G12L5X8K (gadobenic acid)
RN  - 6HG8UB2MUY (Meglumine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Pressure/drug effects
MH  - Contrast Media/*adverse effects
MH  - Electrocardiography/drug effects
MH  - Female
MH  - Humans
MH  - Magnetic Resonance Imaging
MH  - Male
MH  - Meglumine/*adverse effects/analogs & derivatives
MH  - Middle Aged
MH  - Organometallic Compounds/*adverse effects
MH  - Product Surveillance, Postmarketing/*statistics & numerical data
MH  - Safety Management
EDAT- 2001/09/06 10:00
MHDA- 2001/09/14 10:01
CRDT- 2001/09/06 10:00
PHST- 2001/09/06 10:00 [pubmed]
PHST- 2001/09/14 10:01 [medline]
PHST- 2001/09/06 10:00 [entrez]
AID - 10.1002/jmri.1184 [pii]
AID - 10.1002/jmri.1184 [doi]
PST - ppublish
SO  - J Magn Reson Imaging. 2001 Sep;14(3):281-94. doi: 10.1002/jmri.1184.