Side-effects of sodium valproate, mainly related to its hepatic and pancreatic toxicity

A study was made of 134 patients (67 males and 67 females) treated with sodium valproate, with ages from 1.5 to 70 years (50 on monotherapy and 84 on multitherapy), to detect side-effects of this treatment. To meet this goal, a clinical questionnaire was used with special emphasis on biological parameters to detect hepatic and pancreatic toxicity. 71.6% developed side-effects, without differences either between groups of sex or age, or patients on monotherapy and multitherapy, or the duration of the treatment, longer or shorter than six months. The side-effects were mild and transient, and without relationship with doses or plasma levels of the drug. The most noticeable side-effects in the study were the increase in amylase values, mainly in urine (23.9%), eosinophilia (30% in the monotherapy group), increase in gamma-glutamyltranspeptidase (20.2% in the polytherapy group) and weight gain in 25% of adult women on polytherapy. Only a 4.7% developed mild and transient elevation of transaminases, that did not differ from the control population. The relevance of using a clinical questionnaire and biological parameters to evaluate the side-effects of a drug is emphasized.