PMID- 24172794
OWN - NLM
STAT- MEDLINE
DCOM- 20140821
LR  - 20190608
IS  - 1880-2206 (Electronic)
IS  - 1347-3182 (Linking)
VI  - 12
IP  - 4
DP  - 2013 Dec 25
TI  - Safety of gadopentetate dimeglumine after 120 million administrations over 25 
      years of clinical use.
PG  - 297-304
AB  - PURPOSE: We evaluated the safety of gadopentetate dimeglumine (Gd-DTPA), the 
      first contrast agent for magnetic resonance imaging, using pharmacovigilance data 
      for spontaneously reported adverse events (AEs) after 120 million cumulative 
      administrations worldwide. METHODS: We analyzed spontaneously reported AEs for 
      Gd-DTPA for pre-specified time periods between 1988 and 2011. RESULTS: Since the 
      market introduction of Gd-DTPA in 1988, its global utilization reached 120 
      million cumulative administrations in 2011, more than 80% of which was by the 
      USA, countries in the European Union (EU), and Japan. The global AE reporting 
      rate was 21.2 in 100,000 administrations in 1988 and 14.4 in 100,000 
      administrations by 2011. Regional differences included higher reporting rates in 
      the USA and Japan, and reporting rates lower than global rates in the EU. The 
      reported rate of global serious AEs changed from 1.4 in 100,000 administrations 
      in 1988 to 4.0 in 100,000 administrations in 2011. The highest number of reports 
      of nephrogenic systemic fibrosis (NSF) was received from 2006 to 2008. Since 
      2009, no report of a current onset of NSF has been received. The reduced report 
      rate of NSF may be due to increased awareness about the use of gadolinium-based 
      contrast agents (GBCAs). CONCLUSION: After more than 120 million cumulative 
      administrations, Gd-DTPA is a widely used GBCA that shows a consistently low and 
      stable incidence of AEs.
FAU - Matsumura, Toru
AU  - Matsumura T
AD  - Bayer Yakuhin Ltd., Medical Affairs Pharmacovigilance.
FAU - Hayakawa, Masakane
AU  - Hayakawa M
FAU - Shimada, Fumiki
AU  - Shimada F
FAU - Yabuki, Masahisa
AU  - Yabuki M
FAU - Dohanish, Susan
AU  - Dohanish S
FAU - Palkowitsch, Petra
AU  - Palkowitsch P
FAU - Yoshikawa, Kohki
AU  - Yoshikawa K
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20131029
PL  - Japan
TA  - Magn Reson Med Sci
JT  - Magnetic resonance in medical sciences : MRMS : an official journal of Japan 
      Society of Magnetic Resonance in Medicine
JID - 101153368
RN  - 0 (Contrast Media)
RN  - K2I13DR72L (Gadolinium DTPA)
SB  - IM
MH  - Contrast Media/adverse effects
MH  - Drug Utilization Review/*statistics & numerical data
MH  - Europe
MH  - Gadolinium DTPA/*adverse effects
MH  - Humans
MH  - Internationality
MH  - Japan
MH  - Longitudinal Studies
MH  - Magnetic Resonance Imaging/*statistics & numerical data
MH  - Nephrogenic Fibrosing Dermopathy/*epidemiology/*etiology
MH  - Pharmacovigilance
MH  - *Registries
MH  - United States
EDAT- 2013/11/01 06:00
MHDA- 2014/08/22 06:00
CRDT- 2013/11/01 06:00
PHST- 2013/11/01 06:00 [entrez]
PHST- 2013/11/01 06:00 [pubmed]
PHST- 2014/08/22 06:00 [medline]
AID - DN/JST.JSTAGE/mrms/2013-0020 [pii]
AID - 10.2463/mrms.2013-0020 [doi]
PST - ppublish
SO  - Magn Reson Med Sci. 2013 Dec 25;12(4):297-304. doi: 10.2463/mrms.2013-0020. Epub 
      2013 Oct 29.