These highlights do not include all the information needed to use VALPROATE SODIUM INJECTION, USP safely and effectively. See full prescribing information for VALPROATE SODIUM INJECTION, USP.VALPROATE SODIUM INJECTION, USP for intravenous injectionInitial U.S. Approval: 1996

WARNING: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning Hepato toxicity, including fatalities, usually during first 6 months o f treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients c losely, and perform serum liver testing prior to therapy and at frequent intervals thereafter (5.1) Fetal Risk, particularly neural tube defects, o ther major malformations, and decreased IQ (5.2, 5.3, 5.4 ) Pancreatitis, including fatal hemorrhag ic cases (5.5)