Vol.70 No.4 July 2022
Assessment of the incidence of joint-related adverse effects in patients under the age of 18 years treated with tosufloxacin based on the Japanese health insurance claims database
1)Department of Infectious Diseases, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
2)FUJIFILM Toyama Chemical Co., Ltd.
Abstract
Using the Japanese health insurance claims database provided by the JMDC Inc., we assessed the incidence of joint-related adverse effects (AEs) in patients under the age of 18 years treated with tosufloxacin (TFLX) between January 1, 2010, and December 31, 2019. The results were as follows:
1) The incidence of joint-related AEs in patients under the age of 18 years treated with TFLX was 10.42%, similar to that in the patient group treated with non-fluoroquinolone systemic antibacterial agents (Non-Quinolones group), which was 10.57%. In addition, the incidences classified by the interval between the initial dose and the first onset and by the age at the initial dose were similar between the TFLX-group and the Non-Quinolones group.
2) The incidence of joint-related AEs classified by the number of administrations was in the range of 9.52-10.74%, almost regardless of the number of administrations in the TFLX group.
3) The incidence of joint-related AEs in the TFLX group as assessed by the person-years method, which takes into consideration the observation period in each insured subject, was 31.48 (1,000 person-years), similar to that in the Non-Quinolones group (32.24; 1,000 person-years) and the relative risk against the Non-Quinolones group was 0.98 (95% Confidence interval: 0.96-0.99).
This is the first long-term assessment of the incidence of joint-related AEs in patients under the age of 18 years treated with TFLX using medical receipt data. The results revealed no clinically detectable differences in the incidence of joint-related AEs between patients under 18 years of age treated with TFLX or Non-Quinolones.
Although the incidence of joint-related AEs in patients under the age of 18 years treated with TFLX or Non-Quinolones appears to be similar, it is necessary to continue to collect its safety information, including on joint symptoms, to promote safe and effective use of TFLX as a treatment option for pneumonia and otitis media in children.
Key word
tosufloxacin, health insurance claim, child, joint-related adverse effect
Received
March 2, 2022
Accepted
May 26, 2022
Jpn. J. Chemother. 70 (4): 366-372, 2022
