Vol.66 No.5 September 2018
Efficacy and safety of fluconazole in infants including neonates a special drug use-results survey
1)Medical Affairs, Global Established Pharma Business Unit, Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan
(Present: Hospital Division, Essential Health, Pfizer Japan Inc.)
2)Post-Marketing Surveillance Planning and Management, Pfizer Japan Inc.
3)Clinical Statistics, Pfizer Japan Inc.
4)Statistical Programming and Analysis, Pfizer Japan Inc.
5)Data Monitoring and Management, Pfizer Japan Inc.
6)Medical Affairs, Global Established Pharma Business Unit, Pfizer Japan Inc.
(Present: Post-Marketing Surveillance Planning and Management, Pfizer Japan Inc.)
Abstract
In November 2011, fluconazole injection (Diflucan® intravenous solution 50 mg/100 mg/200 mg) and fluconazole capsules (Diflucan® capsules 50 mg/100 mg) were approved additionally for prevention of invasive fungal infections in patients with hematopoietic stem cell transplantation and for children through public knowledge-based application in Japan. Additionally, fluconazole dry syrup (Diflucan® dry syrup 350 mg/1,400 mg) was approved as a new formulation in February 2012. However, few reports describe the clinical use experience of fluconazole in infants and newborns in Japan. In order to evaluate the safety and efficacy of fluconazole in children including neonates in clinical practice in Japan, a special drug use-results survey was carried out. As far as adverse drug reactions were concerned, one patient developed a liver disorder among 27 patients in the safety analysis set, thus the proportion of adverse drug reaction was 3.7% (1/27 cases). No serious or unanticipated adverse drug reactions were observed. As for efficacy, two patients were treated with fluconazole among 27 patients in the efficacy analysis set. Of the two patients, fluconazole was efficacious in one patient and the efficacy in the other patient was indeterminable. The mycological efficacy was determined for one patient, and the fungal eradication was not observed. No patients developed an invasive fungal infection among 25 patients in whom fluconazole for was administered prophylaxis. Therefore, as for the safety and efficacy of fluconazole in infants and neonates, it was considered that no remarkable findings should require additional precautions.
Key word
fluconazole, child, fungal infection, postmarketing surveillance, adverse reaction
Received
November 29, 2017
Accepted
April 3, 2018
Jpn. J. Chemother. 66 (5): 600-609, 2018
