Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: Results of the US multicenter Phase III clinical trials (safety)

The short-term(1) safety of mangafodipir trisodium (MnDPDP) injection was s tudied in 546 adults with known or suspected focal liver lesions. An initia l contrast-enhanced computed tomography examination was followed by unenhan ced magnetic resonance imaging (NM), injection of MnDPDP (5 mu mol/kg), and enhanced AM. Adverse events were reported for 23% of the patients; most we re mild to moderate in intensity, did not require treatment, and were not d rug related. The most commonly reported adverse events were nausea (7%) and headache (4%). The incidence of serious adverse events was low (nine event s in six patients) and not drug related. Injection-associated discomfort wa s reported for 69% of the patients, and the most commonly reported discomfo rts included heat (49%) and flushing (33%). Changes in laboratory values an d vital signs were generally transient, were not clinically significant, an d did not require treatment. There were no clinically significant short-ter m risks from exposure to MnDPDP. (C) 2000 Wiley-Liss, Inc.