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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)

Publication Type:

Journal Article

Source:

J Magn Reson Imaging, Volume 12, Number 1, p.186-97 (2000)

Accession Number:

10931579

Keywords:

Abdominal Pain/chemically induced, Adult, Aged, Aged, 80 and over, Cardiovascular Diseases/chemically induced, Contrast Media/adverse effects, Diagnosis, Differential, Edetic Acid/adverse effects/*analogs & derivatives/diagnostic use, Female, Human, Image Enhancement/*methods, Injections, Intravenous/adverse effects, Liver Cirrhosis/*diagnosis, Liver Neoplasms/*diagnosis, Magnetic Resonance Imaging/*methods, Male, Middle Age, Pain/etiology, Pregnancy, Pyridoxal Phosphate/adverse effects/*analogs & derivatives/diagnostic use, Risk Assessment, Sensitivity and Specificity, Support, Non-U.S. Gov't, Vomiting/chemically induced

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.