ABSTRACT: The use of midazolam for children was approved in March, 2010. Since the efficacy and safety data of midazolam used in children, excluding low-birth-weight infants and newborns, for "sedation under artificial respiration in intensive care units" were quite limited, a post-marketing survey was carried out to confirm the validity of the established dosage and administration.
A consecutive enrollment method was adopted. Based on the data of 153 patients collected from 8 institutes, efficacy and safety profiles were analyzed.
Among the 149 patients included in the safety analysis set, 6 adverse reactions were reported in 6 patients. The incidence of adverse events was 4.0% (6/149). Reported adverse reactions included depressed level of consciousness: 1 event, delirium: 1 event, psychomotor hyperactivity: 1 event, hypotension: 2 events, and blood pressure increase: 1 event. Serious adverse drug reaction (ADR) reported in this survey was depressed level of consciousness. This ADR resolved on the following day after the treatment with flumazenil. Paradoxical reactions were reported in 1 patient, and tolerance was reported in 2 patients. The efficacy rate was 96.5% (138/143).
No additional safety issues (status of adverse reactions, status of adverse events, status of serious adverse events, etc.) and efficacy issue were manifest in the patients treated with the dosage and administration method established at the approval of the drug.
Masui. The Japanese journal of anesthesiology 11/2012; 61(11):1245-60.
Journal of Infection and Chemotherapy 07/2011; · 1.80 Impact Factor
ABSTRACT: The safety and efficacy of micafungin were evaluated in a Japanese post-marketing survey involving 1,142 patients with deep mycosis caused by Candida or Aspergillus. The overall clinical response was 83.0%, and the respective responses for patients with candidiasis or aspergillosis were 86.3 and 70.8%. With regard to drug reactions, 562 adverse reactions were observed in 28.5% of patients. Among the 83 serious adverse drug reactions reported by 53 patients, a causal relationship with micafungin was assessed as definite or probable for 6 reactions in 5 patients. Age and baseline hepatic and renal function status did not affect the incidence of adverse reactions, although incidence increased significantly in proportion to the severity of mycosis and daily dose (p < 0.01). In multiple logistic regression analysis, neither baseline hepatic impairment nor increased daily dose of micafungin affected the incidence of hepatobiliary disorders, however, the severity of mycosis was found to correlate significantly with hepatobiliary disorders (p = 0.031). Taken together, our post-marketing findings show that micafungin is effective against deep mycosis caused by Candida or Aspergillus in patients across a range of backgrounds.
Journal of Infection and Chemotherapy 03/2011; 17(5):622-32. · 1.80 Impact Factor