Abstract
In order to confirm the efficacy and safety of Desmopressin Injection 4 Kyowa, we conducted a post-marketing survey in the patients with mild / moderate hemophilia A or type 1 / type2A von Willebrand disease in Japan. During the ten-year survey, 234 patients from 83 medical institutions were enrolled. Two hundred twelve patients were eligible for the analysis of safety. One hundred thirty nine adverse reactions were reported in 66 patients (31.13%). Frequent adverse reactions were facial flushing (39 events, 18.40%), warm feeling (27 events, 12.74%), hot flushes (18 events, 8.49%), headache (13 events, 6.13%), oliguria (12 events, 5.66%), nausea (7 events, 3.30%) and thirst 7 events, 3.30%). Two cases of convulsive attack were reported and one of the events could have been prevented with a care on fluid balance. Based on these results of the survey, we considered that patients should be carefully controlled in fluid replacement therapy and water intake.
Hemostatic effects were found 65.22%, 62.50%, 93.10% and 94.74% in the patients with mild hemophilia A, moderate hemophilia A, type 1 von Willebrand disease and type2A von Willebrand disease, respectively. The percentage of clotting factors improvement were found 76.47%, 85.71% and 100% in the patients with hemophilla A, type 1 von Willebrand disease and type2A von Willebrand disease, respectively.
