Valproic acid hepatic fatalities: a retrospective review.

We reviewed all US cases of fatal hepatotoxicity coincident with valproate anticonvulsant therapy that were reported between 1978 and 1984. Thirty-seven hepatic fatalities were determined to have occurred coincident with the use of valproate. All but one patient had such other medical conditions as mental retardation, developmental delay, congenital abnormalities, and other neurologic diseases. The primary risk of fatal hepatic dysfunction (1/500) was found to be in children 0 to 2 years old receiving valproate as polytherapy. The risk declined with age and was low in patients receiving valproate as monotherapy (1/37,000). No hepatic fatalities occurred in patients above the age of 10 years receiving valproate as monotherapy.

Evidence of lack of abuse or dependence following pemoline treatment: results of a retrospective survey.

Pemoline is recognized as an efficacious and safe therapeutic agent for children suffering from Attention Deficit Disorder (ADD). A review of adverse experience reports submitted to the manufacturer suggests that Cylert (brand of pemoline) has a limited potential for abuse or dependence. Drug dependence studies in animals have demonstrated that pemoline is not self-administered in naive nor cocaine-dependent animals. Human experience indicates that, despite the fact that the drug has been available in the U.S. since 1975, use is limited and is increasing slowly. A review of the literature revealed no published case reports of euphoria, abuse, dependence or withdrawal. While there have been a few reports of tolerance, it is possible that these were a reflection of inadequate dosing rather than actual tolerance to the drug's therapeutic effects. During the 10 years that Cylert has been available in the United States, there have been only four reports of withdrawal reactions and no reported cases of dependence. Reports of intentional overdose of Cylert are minimal, with no reports involving abuse via the intravenous route.