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Safety and Efficacy of Mangafodipir Trisodium (MnDPDP) Injection for Hepatic MRI in Adults: Results of the U.S. Multicenter Phase III Clinical Trials (Safety)
Author(s) -
Federle Michael P.,
Chezmar Judith L.,
Rubin Daniel L.,
Weinreb Jeffrey C.,
Freeny Patrick C.,
Semelka Richard C.,
Brown Jeffrey J.,
Borrello Joseph A.,
Lee Joseph K.T.,
Mattrey Robert,
Dachman Abraham H.,
Saini Sanjay,
Harmon Ben,
Fenstermacher Marc,
Pelsang Retta E.,
Harms Steven E.,
Mitchell Donald G.,
Halford III Hollis H.,
Anderson Mark W.,
Johnson C. Daniel,
Francis Isaac R.,
Bova James G.,
Kenney Philip J.,
Klippenstein Donald L.,
Foster Gregory S.,
Turner David A.,
Stillman Arthur E.,
Nelson Rendon C.,
Young Stuart W.,
Patt Richard H.,
Rifkin Matthew,
Seltzer Steven E.,
Gay Spencer B.,
Robison Ronald O.,
Sherwin Paul F.,
Ballerini Rocco
Publication year - 2000
Publication title -
journal of magnetic resonance imaging
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.563
H-Index - 160
eISSN - 1522-2586
pISSN - 1053-1807
DOI - 10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2
Subject(s) - medicine , adverse effect , nausea , magnetic resonance imaging , radiology , clinical trial , incidence (geometry) , vomiting , nuclear medicine , anesthesia , physics , optics
The short‐term 1 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 μmol/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. J. Magn. Reson. Imaging 2000;12:186–197. © 2000 Wiley‐Liss, Inc.