Short-Term Side Effects of Low Dose Valproate Monotherapy in Epileptic Children: A Prospective Study

Iran J Child Neurol. 2019 Spring;13(2):37-46.

Abstract

Objectives: Considering the common use of valproate among children, we investigated the short-term side-effects of low dose valproate monotherapy in epileptic children.

Materials & methods: In this prospective study, 209 epileptic children (48.3% male, mean age: 7.02 ± 3.13 yr) on low therapeutic dose of valproate monotherapy (20-30 mg/kg/d) were enrolled during 2014-2015 in Isfahan Pediatric Neurology Clinic, Isfahan University of Medical Sciences, Isfahan, Iran and side-effects were evaluated through frequent clinical visits and laboratory tests during 6 months of valproate therapy.

Results: Weight gain was reported in 53.1% of patients. Decreased appetite was seen in 11% of patients, more frequent in younger cases (P=0.006). Abdominal pain, nausea/vomiting, diarrhea, and constipation were reported in 16.3%, 2.4%, 1.4%, and 1% of patients, respectively. Headache, tremor, dizziness, abnormal color vision, myoclonus, and bruxism were seen in 5.7%, 1.4%, 1%, 1%, 1%, and 0.5% of patients, respectively. Enuresis, hair loss, and skin rash were reported in 8.1%, 6.7%, and 0.5% of patients, respectively. Thrombocytopenia, impaired liver function tests, and leukopenia occurred in 1%, 1%, and 0.5% of patients, respectively.

Conclusion: Low dose valproate monotherapy may cause numerous side-effects, mostly not life-threatening and requiring no action. Besides more reported complications, we observed decreased appetite (among younger patients), enuresis, and abnormal color vision which are onlybriefly discussed in the literature and need to be addressed more.

Keywords: Adverse drug reactions; Epilepsy; Pediatrics; Valproate monotherapy.