Simulect Adverse Reactions

In 2 controlled trials, the pattern of adverse events in 363 patients treated with the recommended dose of Simulect was indistinguishable from that in 359 patients treated with placebo. Simulect did not appear to add to the background of adverse events seen in organ transplant patients as consequence of their underlying disease and the concurrent administration of immunosuppressant and other medications. Adverse events were reported by 99% of the patients in the Simulect-treated group. Simulect did not increase the incidence of serious adverse events observed when compared to placebo. The most commonly reported (>20%) events in both treatment groups were constipation, urinary tract infection, pain, nausea, peripheral edema, hypertension, anemia, headache and hyperkalemia.
Incidence of Malignancies: The overall incidence of malignancies among all patients in the two 12-month controlled trials was not significantly different between the Simulect and the placebo-treatment groups. Overall, lymphoma/lymphoproliferative disease occurred in 1 patient (0.3%) in the Simulect group compared with 2 patients (0.6%) in the placebo group. Other malignancies were reported among 5 patients (1.4%) in the Simulect group compared with 7 patients (1.9%) in patients treated with placebo.
Incidence of Infectious Episodes: Cytomegalovirus infections were reported in 14% of Simulect-treated patients and 18% of placebo-treated patients. The rates of infections were 81% in both groups; for serious infections, they were 28% in the Simulect and 27% in the placebo group, while for infectious organism, they were similar in both the Simulect- and the placebo-treatment groups.
The incidence and causes of deaths were similar in both groups, with the most common cause of deaths in the both treatment groups being infections (13/26 or 50%).