In clinical trials, a total of 637 subjects (57 healthy volunteers and 580 patients) with known or suspected liver lesions received the contrast agent at a dose of 5 µmol/kg. Of these subjects, there were 387 men and 250 women with a mean age of 56 years (19 to 86).There were 497 (78%) Caucasian, 72 (11%) Black, 32 (5%) Oriental, and 36 (6%) in other racial groups.

Of these 637 subjects, 481 (76%) reported at least one adverse event.In clinical trials, there were 4 deaths and 2 serious events. The serious events included prolonged vomiting in one patient. The deaths occurred in patients with advanced multisystem disease (hepatocellular carcinoma, esophageal variceal bleeding, sepsis, and pneumonia) and were attributed to the underlying disorders.

The most commonly noted adverse experiences were injection site discomfort 430 (67%), headache - 32 (5%), and any gastrointestinal event - 79 (12%).(See Table 5 for details.)

As with other contrast media, patients receiving TESLASCAN reported injection-associated discomfort. Overall 430 (67%) of the patients receiving TESLASCAN reported mild to moderate injection-associated discomfort. Of these, the discomfort was described as heat 266 (42%), flushing 234 (36%), pressure 26 (4%), pain 19 (3%), and cold 9 (1%).

The following selected adverse events occurred in <0.5% of the subjects. The majority (93%) of these adverse events were of mild to moderate intensity:chest pain, dizziness, hot flushes, hypersensitivity, hypertension, palpitation, pruritus, rash, taste perversion, urticaria.

In another 798 subjects who received the contrast agent in foreign clinical trials, similar types and rates of adverse events were reported.

Drug interactions with other contrast agents and other drugs were not studied.

Transmetalation of manganese may occur.The extent to which this might affect laboratory assays of ferritin, iron, bilirubin, and zinc is not known.

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