Literature DB >> 10931579

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

M P Federle1, J L Chezmar, D L Rubin, J C Weinreb, P C Freeny, R C Semelka, J J Brown, J A Borello, J K Lee, R Mattrey, A H Dachman, S Saini, B Harmon, M Fenstermacher, R E Pelsang, S E Harms, D G Mitchell, H H Halford, M W Anderson, C D Johnson, I R Francis, J G Bova, P J Kenney, D L Klippenstein, G S Foster, D A Turner.   

Abstract

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.

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Year:  2000        PMID: 10931579     DOI: 10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2

Source DB:  PubMed          Journal:  J Magn Reson Imaging        ISSN: 1053-1807            Impact factor:   4.813


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