Warnings & Recalls for Divalproex sodium

Black box warning

Hepatotoxicity

serious or fatal hepatic failure reported, usually in 1st 6mo of tx preceded by malaise, weakness, lethargy, facial edema, anorexia, vomiting and loss of seizure control; incr. risk fatal hepatotoxicity if <2 yo especially if multiple anticonvulsant tx, congenital metabolic disorder, severe seizure disorder w/ mental retardation, or organic brain dz; in pts <2 yo, weigh benefit vs. risk, use w/ extreme caution as monotherapy; incidence of fatal hepatotoxicity decr. considerably in progressively older pt groups >2 yo; monitor hepatotoxicity s/sx incl. LFTs at baseline and frequently thereafter especially in 1st 6mo

Teratogen

can cause teratogenic effects incl. neural tube defects; weigh benefits/risks before use in women of child-bearing potential especially if used for spontaneously reversible event not usually associated w/ permanent injury or fatality risk

Pancreatitis

Cases of Life-threatening pancreatitis have been reported in both children and adults receiving 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. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternate treatment for the underlying medical condition should be initiated as clinically indicated. (See warnings and precautions).

Other warnings

You shouldn't be on divalproex sodium if you are allergic to any ingredient in this medication or have liver disease, or a urea cycle disorder. So be sure to tell your doctor if you have any of these before starting this medication. Other conditions you should tell your doctor about include a bleeding or clotting disorder; a history of head injury, brain disorder, or coma; a family history of a urea cycle disorder or infant deaths with unknown cause; or HIV or CMV infection. Tell your doctor if you have any thoughts about suicide that are new or worsening depression or suicidal thoughts.

Drugs that may interact with Divalproex sodium

• topiramate (Topamax);
• tolbutamide (Orinase);
• a blood thinner such as warfarin (Coumadin, Jantoven);
• aspirin or acetaminophen (Tylenol);
• zidovudine (Retrovir);
• clozapine (Clozaril, FazaClo);
• diazepam (Valium);
• meropenem (Merrem) or imipenem and cilastatin (Primaxin);
• rifampin (Rifadin, Rimactane, Rifater); or
• ethosuximide (Zarontin).

Family planning

The FDA categorizes divalproex sodium as a category D pregnancy because it can cause birth defects. Some of the birth defects include cleft palate; fetal death; growth retardation; hand deformations; heart malformations; dydranencephaly; hypoplasia; iniencephaly; neural tube birth defects; skeletal birth defects; or spina bifida. There have been recent studies that have linked anticonvulsant medication like dicalproex sodium to one of the most common causes as harm to a fetus in utero in 1% to 2% of infants. See your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding. Don't stop taking this medication if you become pregnant without telling your doctor because he may offer a safer alternative treatment.