zonisamideの小児における発汗抑制
http://www.fda.gov/cder/approval/z.htm
から抜粋
Oligohidrosis and Hyperthermia in Pediatric Patients:
Oligohidrosis, sometimes resulting in heat stroke and hospitalization, is seen in association with zonisamide in pediatric patients.
During the pre-approval development program in Japan, one case of oligohidrosis was reported in 403 pediatric patient,
an incidence of 1 ease per 285 patient-years of exposure. While there were no cases reported in the US or European
development programs, fewer than 100 pediatric patients participated in these trials.
In the first 11 years of marketing in Japan, 38 cases were reported, an estimated reporting rate of about 1 case
per 10,000 patient-years of exposure. In the first year of marketing in the US, 2 cases were reported, an estimated
reporting rate of about 12 cases per 10,000 patient-years of exposure. These rates are underestimates of the true
incidence because of under-reporting. There has also been one report of heat stroke in an 1 8-year-old patient in the US.
Decreased sweating and an elevation in body temperature above normal characterized these cases. Many cases were
reported after exposure to elevated environmental temperatures. Heat stroke, requiring hospitalization, was
diagnosed in some cases. There have been no reported deaths.
Pediatric patients appear to be at an increased risk for zonlsamid~associated oligohidrosis and hyperthermia.
Patients, especially pediatric patients, treated with Zonegran should be monitored dosely for evidence of
decreased sweating and increased body temperature, especially in warm or hot weather. Caution should be used
when zonisamide is prescribed with other drugs that predispose patients to heat-related disorders; these drugs
include, but are not limited to, carbonic anhydrase inhibitors and drugs with anticolinergic activity.
The practitioner should be aware that the safety and effectiveness of zonisamide in pediatric patients have
not been established, and that zonleamide is not approved for use in pediatric patients.
Elan Biopharmaceuticals, Inc. August 27,2003: 20789scm001_zonegran_lbl.pdf
[前のページへ]
[JEPNETのホームページへ]
Last update Jul.31.2004