. . "Depakote ER (Tablet, Extended Release)" . . . "BOXED WARNING: WARNING: LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity Hepatic failure resulting in\nfatalities has occurred in patients receiving valproic acid and its\nderivatives. Children under the age of two years are at a considerably\nincreased risk of developing fatal hepatotoxicity, especially those\non multiple anticonvulsants, those with congenital metabolic disorders,\nthose with severe seizure disorders accompanied by mental retardation,\nand those with organic brain disease. When Depakote ER is used in\nthis patient group, it should be used with extreme caution and as\na sole agent. The benefits of therapy should be weighed against the\nrisks. The incidence of fatal hepatotoxicity decreases considerably\nin progressively older patient groups. These\nincidents usually have occurred during the first six months of treatment.\nSerious or fatal hepatotoxicity may be preceded by non-specific symptoms\nsuch as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.\nIn patients with epilepsy, a loss of seizure control may also occur.\nPatients should be monitored closely for appearance of these symptoms.\nLiver function tests should be performed prior to therapy and at frequent\nintervals thereafter, especially during the first six months [see Warnings and Precautions (5.1)]. Teratogenicity Valproate can produce teratogenic\neffects such as neural tube defects (e.g., spina bifida). Accordingly,\nthe use of Depakote ER in women of childbearing potential requires\nthat the benefits of its use be weighed against the risk of injury\nto the fetus. This is especially important when the treatment of a\nspontaneously reversible condition not ordinarily associated with\npermanent injury or risk of death (e.g., migraine) is contemplated [see Warnings and Precautions(5.2)]. An information sheet describing the teratogenic potential of valproate\nis available for patients [see Patient\nCounseling Information(17.7)]. Pancreatitis Cases of life-threatening pancreatitis have been reported in both\nchildren and adults receiving valproate. Some of the cases have been\ndescribed as hemorrhagic with a rapid progression from initial symptoms\nto death. Cases have been reported shortly after initial use as well\nas after several years of use. Patients and guardians should be warned\nthat abdominal pain, nausea, vomiting and/or anorexia can be symptoms\nof pancreatitis that require prompt medical evaluation. If pancreatitis\nis diagnosed, valproate should ordinarily be discontinued. Alternative\ntreatment for the underlying medical condition should be initiated\nas clinically indicated [see Warnings\nand Precautions (5.3)]." . . . . . . . . . . . . "Divalproex sodium" . "Depakote ER (Tablet, Extended Release)" . . . "Depakote ER" .