Valpros Pedia Warnings

Life-threatening Adverse Reactions: Hepatotoxicity: Hepatic failure resulting in fatalities has occurred in patients receiving valproate or its derivatives, usually during the first 6 months of treatment. Patients who are at a considerable risk of having hepatotoxicity are those taking multiple anticonvulsants, those with congenital metabolic disorders, severe seizure disorder associated with brain damage and/or mental retardation, those with organic brain disease, and children less than 2 years old. Above this age group, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreased considerably in progressively older patient (see Precautions).
Fetal Risk: Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores following in utero exposure. Accordingly, the use of sodium valproate syrup in pregnant women requires that the benefits of its use be weighed against the risk of harm to the fetus (see Use in Pregnancy & Lactation).
Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA polymerase-γ (POLG) gene (e.g., Alpers Huttenlocher Syndrome). Sodium valproate is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children <2 years old who are clinically suspected of having a mitochondrial disorder (see Precautions).
Pancreatitis: Cases of life-threatening pancreatitis have been reported in both adults and children receiving sodium valproate. Some of the cases have been described as hemorrhagic, with a rapid progression from initial symptoms to death. Cases have been reported shortly after initial use as well as after several years of use (see Precautions).