PMID- 1812350
OWN - NLM
STAT- MEDLINE
DCOM- 19920611
LR  - 20190824
IS  - 0740-3194 (Print)
IS  - 0740-3194 (Linking)
VI  - 22
IP  - 2
DP  - 1991 Dec
TI  - Safety of gadolinium-DTPA: extended clinical experience.
PG  - 222-8; discussion 229-32
AB  - This review reports data on the general and renal tolerance of the paramagnetic 
      contrast agent Gd-DTPA after intravenous administration. Gd-DTPA was administered 
      usually at a dose level of 0.1-0.2 mmol/kg body wt (range: 0.005-0.25 mmol/kg 
      body wt) in cranial, spinal and body MR indications. In phase I-IIIa studies a 
      total of 2154 healthy volunteers and patients were investigated, usually at a 
      dose of 0.1 mmol/kg body wt. From the obtained results it was concluded that 
      adverse events (AEs) may be expected in the order of magnitude of 1%. In phase 
      IIIb-IV studies 13,439 patients were investigated at 0.1 or 0.2 mmol/kg body wt. 
      Tolerance data were collected according to a standardized protocol and 
      metaanalysis of obtained data was performed. AEs, irrespective of their drug 
      relationship, were observed in 1.15% of the patients. The observed AEs were 
      comparable to those after intravenous administration of iodinated nonionic X-ray 
      contrast media. There was no correlation between patient age and the incidence of 
      AEs. In patients with a known history of allergy the incidence of AEs increased 
      to 2.6%. In pediatric use no added risk was observed in a total of 826 neonates, 
      children, and adolescents up to 18 years of age. Gd-DTPA showed good renal 
      tolerance in patients with and without preexisting impairment of renal function. 
      A prospective open safety and pharmacokinetic study was conducted in patients 
      with hemodialysis. Gd-DTPA was shown to be eliminated completely by hemodialysis. 
      Fast bolus injections were tolerated without added risk. Presented data from 
      postmarketing surveillance (up to March 31, 1991) cover an estimated total of 
      more than 2,000,000 applications.(ABSTRACT TRUNCATED AT 250 WORDS)
FAU - Niendorf, H P
AU  - Niendorf HP
AD  - Clinical Research Diagnostics, Schering AG, Berlin, Federal Republic of Germany.
FAU - Haustein, J
AU  - Haustein J
FAU - Cornelius, I
AU  - Cornelius I
FAU - Alhassan, A
AU  - Alhassan A
FAU - Clauss, W
AU  - Clauss W
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Magn Reson Med
JT  - Magnetic resonance in medicine
JID - 8505245
RN  - 0 (Contrast Media)
RN  - 0 (Organometallic Compounds)
RN  - 7A314HQM0I (Pentetic Acid)
RN  - K2I13DR72L (Gadolinium DTPA)
SB  - IM
MH  - Adult
MH  - Child
MH  - Contrast Media/*adverse effects
MH  - Gadolinium DTPA
MH  - Humans
MH  - Incidence
MH  - Kidney/drug effects
MH  - *Magnetic Resonance Imaging
MH  - Organometallic Compounds/*adverse effects
MH  - Pentetic Acid/*adverse effects
MH  - Product Surveillance, Postmarketing
RF  - 16
EDAT- 1991/12/01 00:00
MHDA- 1991/12/01 00:01
CRDT- 1991/12/01 00:00
PHST- 1991/12/01 00:00 [pubmed]
PHST- 1991/12/01 00:01 [medline]
PHST- 1991/12/01 00:00 [entrez]
AID - 10.1002/mrm.1910220212 [doi]
PST - ppublish
SO  - Magn Reson Med. 1991 Dec;22(2):222-8; discussion 229-32. doi: 
      10.1002/mrm.1910220212.