Audience: Neurologists, Pediatricians, and other healthcare professionalsFDA and Elan Pharmaceuticals added a bolded WARNING to inform healthcare professionals that pediatric patients appear to be at an increased risk for zonisamide-associated oligohidrosis and hyperthermia. Patients, especially pediatric patients, treated with Zonegran should be monitored closely for evidence of decreased sweating and increased body temperature, especially in warm or hot weather. The safety and effectiveness of zonisamide in pediatric patients have not been established. Zonisamide is not approved for use in pediatric patients.
[June, 2002 Letter - Elan Pharmaceuticals]
[June, 2002 Full, revised label and Patient Information leaflet - Elan Pharmaceuticals]