Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety).

Published

Journal Article

The short-term safety of mangafodipir trisodium (MnDPDP) injection was studied in 546 adults with known or suspected focal liver lesions. An initial contrast-enhanced computed tomography examination was followed by unenhanced magnetic resonance imaging (MRI), injection of MnDPDP (5 micromol/kg), and enhanced MRI. Adverse events were reported for 23% of the patients; most were mild to moderate in intensity, did not require treatment, and were not drug related. The most commonly reported adverse events were nausea (7%) and headache (4%). The incidence of serious adverse events was low (nine events in six patients) and not drug related. Injection-associated discomfort was reported for 69% of the patients, and the most commonly reported discomforts included heat (49%) and flushing (33%). Changes in laboratory values and vital signs were generally transient, were not clinically significant, and did not require treatment. There were no clinically significant short-term risks from exposure to MnDPDP.

Full Text

Duke Authors

Cited Authors

  • Federle, MP; Chezmar, JL; Rubin, DL; Weinreb, JC; Freeny, PC; Semelka, RC; Brown, JJ; Borello, JA; Lee, JK; Mattrey, R; Dachman, AH; Saini, S; Harmon, B; Fenstermacher, M; Pelsang, RE; Harms, SE; Mitchell, DG; Halford, HH; Anderson, MW; Johnson, CD; Francis, IR; Bova, JG; Kenney, PJ; Klippenstein, DL; Foster, GS; Turner, DA

Published Date

  • July 2000

Published In

Volume / Issue

  • 12 / 1

Start / End Page

  • 186 - 197

PubMed ID

  • 10931579

Pubmed Central ID

  • 10931579

Electronic International Standard Serial Number (EISSN)

  • 1522-2586

International Standard Serial Number (ISSN)

  • 1053-1807

Digital Object Identifier (DOI)

  • 10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2

Language

  • eng