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Oligohydrosis and fever in pediatric patients treated with zonisamide
James F Knudsen1, Lopa R Thambi, Leonard P Kapcala
1Center for Drug Evaluation and Research, Division of Neuropharmacological Drug Products, Rockville, Maryland 20857, USA.
Insights
Zonisamide, an antiepileptic drug, is linked to oligohydrosis (reduced sweating) in children. Pediatric patients showed a higher reporting rate of this side effect, suggesting a potential risk in this age group.
Area of Science:
- Pharmacology
- Pediatric Neurology
- Adverse Drug Reactions
Background:
- Zonisamide is an antiepileptic medication first marketed in Japan in 1989.
- Oligohydrosis (deficient sweat production) cases were reported in children during zonisamide's development and postmarketing in Japan.
- Zonisamide received FDA approval in the US in 2000 for adjunctive treatment of partial seizures in adults.
Purpose of the Study:
- To identify and analyze cases of zonisamide-associated oligohydrosis and/or fever in the United States.
- To compare the reporting rates of oligohydrosis in pediatric patients in the US versus Japan.
- To investigate potential risk factors, such as pediatric age, for zonisamide-induced oligohydrosis.
Main Methods:
- Searched the Food and Drug Administration's Adverse Events Reporting System (AERS).
- Identified and reviewed domestic cases of zonisamide-associated oligohydrosis and/or fever.
- Calculated the reporting rate of oligohydrosis per pediatric-years of exposure.
Main Results:
- Six domestic cases of zonisamide-associated oligohydrosis and/or fever were identified, all in patients 18 years of age or younger.
- The calculated reporting rate was 13 cases per 10,000 pediatric-years of exposure.
- This rate is approximately 10-fold higher than the reporting rate observed in Japan.
Conclusions:
- Pediatric age may be a risk factor for zonisamide-associated oligohydrosis, potentially due to higher drug blood levels relative to body size.
- Zonisamide may affect eccrine sweat glands by inhibiting carbonic anhydrase, altering pH and calcium dynamics.
- Increased awareness of zonisamide-associated oligohydrosis is crucial for preventing morbidity, particularly in pediatric populations.
Abstract:
Zonisamide is an antiepileptic drug developed and first marketed in Japan in 1989. Cases of oligohydrosis, characterized by deficient production and secretion of sweat, were reported in children treated with zonisamide in Japan during development and in the postmarketing period. Zonisamide was approved in the United States in March 2000 for adjunctive treatment of partial seizures in adults. Searching the Food and Drug Administration's Adverse Events Reporting System, we identified six domestic cases of zonisamide-associated oligohydrosis and/or fever, all in patients