| 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 adult (ages 1 month to 79 years), including 372 newly-diagnosed patients, received zonisamide for partial and generalized epilepsies. Of the intractable patients, 1088 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 (6.5%). Effects that seemed unique to zonisamide were impairment of mental function, motivation or volition, and hipohidrosis. 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, namely anencephaly. |
| Authors | Shunsuke Ohtahara, Yasuko Yamatogi
(Affiliation: Department of Child Neurology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Shikata-cho 2-5-1, Okayama 700-8588, Japan. ohtahara at md.okayama-u.ac.jp)
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| Journal | Seizure : the journal of the British Epilepsy Association
(Seizure)
Vol. 16
Issue 1
Pg. 87-93
(Jan 2007)
ISSN: 1059-1311 England |
| PMID | 17269155
(Publication Type: Corrected and Republished Article, Journal Article)
|
| Chemical References |
- Anticonvulsants
- Isoxazoles
- zonisamide
|
| Topics |
- Abnormalities, Drug-Induced
(etiology)
- Adolescent
- Adult
- Age Factors
- Aged
- Anticonvulsants
(adverse effects, therapeutic use)
- Child
- Child, Preschool
- Drug Therapy, Combination
- Epilepsy
(drug therapy)
- Female
- Follow-Up Studies
- Gastrointestinal Diseases
(chemically induced, epidemiology)
- Humans
- Incidence
- Infant
- Isoxazoles
(adverse effects, therapeutic use)
- Male
- Mental Disorders
(chemically induced, epidemiology)
- Middle Aged
- Product Surveillance, Postmarketing
|
