title: Safety of zonisamide therapy: prospective follow-up survey.
abstract: Zonisamide safety was evaluated based on a postmarketing surveillance study of patients treated for 1-3 years. Nine hundred twenty-eight children and 584 adults (ages 1 month to 79 years), including 372 newly-diagnosed patients, received zonisamide for partial and generalized epilepsies. Of the intractable patients, 1008 received zonisamide in combination with other antiepileptic drugs (AED), and 52 successfully transitioned to zonisamide monotherapy. A total of 1089 adverse events occurred in 476 (31.5%) of 1512 patients. Incidence of adverse effects was significantly lower among patients receiving zonisamide monotherapy than in those receiving polytherapy: 21% (18.9% of children, 29.4% of adults) versus 35.6% (30.4% of children, 41.7% of adults), respectively. The total incidence of adverse effects was lower for children (26.2%) than for adults (39.9%). Most common adverse events included mental/psychiatric symptoms (19.4%), gastrointestinal symptoms (8.7%), and neurological symptoms (5.8%). Effects that seemed unique to zonisamide were impairment of mental function, motivation or volition, and hypohidrosis. Urinary calculi were detected in only two patients (0.13%). Teratogenicity was evaluated in six patients. Two patients on zonisamide monotherapy and three on polytherapy delivered normal children. One of four patients on polytherapy conceived a fetus with a skull defect with cerebral and cerebellar dysgenesis.
authors.affiliation: Department of Child Neurology, Okayama University Medical School, Shikata-cho 2-5-1, Okayama 700-8588, Japan. ohtahara@md.okayama-u.ac.jp
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Ohtahara
authors.forename: Yasuko
authors.initials: Y
authors.lastname: Yamatogi
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000150:complications* / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007223:Infant; D007555:Isoxazoles / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced / Q000453:epidemiology; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D000078305:Zonisamide
chemical_list: D000927:Anticonvulsants; D007555:Isoxazoles; D000078305:Zonisamide