PMID- 27504794
OWN - NLM
STAT- MEDLINE
DCOM- 20171102
LR  - 20220318
IS  - 1536-0210 (Electronic)
IS  - 0020-9996 (Linking)
VI  - 51
IP  - 9
DP  - 2016 Sep
TI  - Adverse Reactions to Gadoterate Meglumine: Review of Over 25 Years of Clinical 
      Use and More Than 50 Million Doses.
PG  - 544-51
LID - 10.1097/RLI.0000000000000276 [doi]
AB  - OBJECTIVE: The aim of this study was to evaluate the safety profile of gadoterate 
      meglumine from clinical trials, postmarketing observational studies, and 
      pharmacovigilance reports of adverse drug reactions (ADRs) encompassing 25 years 
      of clinical use and over 50 million administered doses. MATERIALS AND METHODS: 
      Assessment of the safety of gadoterate meglumine through processing and review of 
      all safety data was collected after magnetic resonance imaging procedures. All 
      ADRs originated from 3 major sources: (1) a clinical study database including 50 
      phase I to IV studies involving 2822 patients, (2) a safety database including 8 
      postmarketing safety studies (PMSs) involving 151,050 patients, and (3) a 
      pharmacovigilance database compiling safety experience following over 50 million 
      doses administered between March 1989 and September 2015. RESULTS: Among the 2822 
      patients receiving gadoterate meglumine in the clinical trials, 241 (8.5%) 
      experienced 405 postinjection adverse events (AEs), considered related to the 
      contrast agent for 113 patients (4.0%). Serious AEs were reported for 27 patients 
      (1.0%) and assessed as related to gadoterate meglumine for 2 patients (0.07%). 
      None of the PMS studies showed evidence of unexpected safety issues, with a very 
      low rate of AEs (<1%). Postmarketing safety experience with over 50 million doses 
      of gadoterate meglumine prescribed for 25 years of approved use worldwide 
      compiled spontaneous reports for 3797 patients who experienced 8397 ADRs, 
      yielding a very low reported incidence of ADRs of 0.007% of patients. There was 
      no single-agent case of confirmed nephrogenic systemic fibrosis with gadoterate 
      meglumine either from clinical development programs or from postmarketing 
      experience. CONCLUSIONS: Based on clinical trials, postmarketing observational 
      studies and pharmacovigilance data, a very low incidence of ADRs was reported 
      with gadoterate meglumine, which has no impact on its favourable benefit-risk 
      ratio.
FAU - de Kerviler, Eric
AU  - de Kerviler E
AD  - From the *Department of Radiology, Saint Louis Hospital APHP and University Paris 
      Diderot, Paris, France; daggerDepartment of Radiology, University of Washington School 
      of Medicine, Seattle, WA; double daggerDepartment of Neuroradiology, Universite Paris 
      Descartes;  section signINSERM UMR894, Hopital Sainte-Anne, Paris; and  parallelGUERBET, Roissy CdG, 
      France.
FAU - Maravilla, Kenneth
AU  - Maravilla K
FAU - Meder, Jean-Francois
AU  - Meder JF
FAU - Naggara, Olivier
AU  - Naggara O
FAU - Dubourdieu, Corinne
AU  - Dubourdieu C
FAU - Jullien, Vincent
AU  - Jullien V
FAU - Desche, Pierre
AU  - Desche P
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PL  - United States
TA  - Invest Radiol
JT  - Investigative radiology
JID - 0045377
RN  - 0 (Contrast Media)
RN  - 0 (Organometallic Compounds)
RN  - 6HG8UB2MUY (Meglumine)
RN  - L0ND3981AG (gadoterate meglumine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Child
MH  - Child, Preschool
MH  - Contrast Media/*adverse effects
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Infant
MH  - Infant, Newborn
MH  - Magnetic Resonance Imaging/methods
MH  - Male
MH  - Meglumine/*adverse effects
MH  - Middle Aged
MH  - Nephrogenic Fibrosing Dermopathy/*chemically induced
MH  - Observational Studies as Topic
MH  - Organometallic Compounds/*adverse effects
MH  - Product Surveillance, Postmarketing/*statistics & numerical data
MH  - Risk Assessment
MH  - Young Adult
EDAT- 2016/08/10 06:00
MHDA- 2017/11/03 06:00
CRDT- 2016/08/10 06:00
PHST- 2016/08/10 06:00 [entrez]
PHST- 2016/08/10 06:00 [pubmed]
PHST- 2017/11/03 06:00 [medline]
AID - 00004424-201609000-00002 [pii]
AID - 10.1097/RLI.0000000000000276 [doi]
PST - ppublish
SO  - Invest Radiol. 2016 Sep;51(9):544-51. doi: 10.1097/RLI.0000000000000276.