The FDA requires that labels on prescribed Depakote include the warning that taking the medication during pregnancy may cause birth defects in the fetus. Depakote is used in the treatment of epilepsy, bipolar disorder and migraine headaches.
The North American Antiepileptic Drug Pregnancy Registry reported that use of drugs like Depakote, which is a form of divalproex sodium, in the first trimester can present a risk for congenital malformations four times greater than with other anti-epileptic drugs. The FDA recommends that pregnant women or women planning to become pregnant use an alternative treatment to Depakote.
Depakote use also has been linked to liver damage, particularly in children under 2 years of age and patients with inherited metabolic disorders. The medication has caused pancreatitis, though the incidents have been rare. Symptoms of liver disease and pancreatitis include unusual tiredness, weakness, vomiting, face swelling, abdominal pain, and loss of appetite.
In May 2012 Abbott Laboratories, which makes Depakote, agreed to pay $1.6 billion in settlement of lawsuits and a Justice Department investigation into allegations that Abbott illegally marketed anti-seizure drug Depakote for treatment of schizophrenia and agitated dementia, uses not approved by the Food and Drug Administration.
Abbott agreed to pay in addition to $800 million to resolve civil claims and $700 million in criminal penalties, $100 million to resolve state-level consumer protection complaints.
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