News Brief: Warning added to zonisamide (Zonegran)

The Food and Drug Administration and Elan Pharmaceuticals have added a bolded warning to zonisamide (Zonegran) to inform health care 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. For more information, see www.fda.gov/medwatch/SAFETY/2002/safety02.htm#zonegr.