DEPAKOTE - Divalproex sodium (comprised of sodium valproate and valproic acid) is an anticonvulsant drug marketed by Abbott Laboratories under the brand names Depakote, Depakote ER (extended release) and Depakote Sprinkles (for sprinkling onto food.)

Depakote was FDA approved in 1983 for the treatment of epilepsy. In 1995 approval broadened to include treatment for manic-depression, and in 1996 it was approved to treat migraine headaches. Beginning in 2008, generic versions of divalproex sodium became available from many drug manufacturers.

The FDA has required multiple black box warnings for Depakote. These warnings address potentially lethal side effects from the ingestion of valproic acid and/or sodium valproate. Some of the most severe consequences from regular Depakote use can include: 

• hepatic (liver) failure resulting in fatalities during the first six months of treatment (especially in children under the age of 2) 
• life-threatening pancreatitis 
• hyperammonemic encephalopathy (blood ammonia toxicity) sometimes resulting in death in patients with urea cycle disorders 
• somnolence (unrelenting sleepiness) in the elderly, with potential nutritional depletion and weight loss 
• elevated liver enzymes (thrombocytopenia) 
• congenital fetus malformations and neural tube defects during pregnancy

A recent FDA alert, issued January 31, 2008 and updated December 16, 2008, describes the agency’s analysis of reports regarding suicidal behavior or suicidal thoughts when taking anticonvulsant drugs, including Depakote. Based on the review of 199 placebo-controlled clinical trials, the FDA now requires manufacturers of the relevant drugs to include a label warning and create a Medication Guide to inform patients of increased risks of suicidal thoughts or actions. Elevated risk was observed throughout the duration of the treatments, and adverse events began to materialize in as little as one week following initial dosage.

In January of 2009, the FDA sent a letter to Abbott Laboratories calling the company’s Pharmacy Formulary Flashcard misleading with regards to risk and material information.

Depakote serious side effects include, but are not limited to:

• vomiting, extreme weakness, confusion or fainting 
• bruising, bleeding or blood in the urine 
• reduced urination
• hallucinations 
• extreme drowsiness 
• double vision or erratic eye movement 
• flu-like symptoms 
• blistering, skin rash or yellowing of the skin 
• clay-colored stools

If you or someone you know has taken Depakote and experienced commonly recognized, or unexplained side effects, use the form below for a free evaluation with an attorney who specializes in Depakote cases. Unsafe drug cases are complex and guidance by a lawyer who is intimately familiar with the drug is crucial.

If you have safety concerns about the use of Depakote, our free evaluation may provide important information. 

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