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DEPAKOTE
by Jane Mundy
Depakote (divalproex sodium) is approved for the treatment of bipolar disorder and certain types of epilepsy. (Divalproex sodium consists of valproic acid and valproate sodium --the salt of valproic acid. Divalproex delayed-release tablets are prescribed for the treatment of manic episodes associated with bipolar disorder and Divalproex sprinkle capsules may be used to control epileptic seizures.) It is also approved for the prevention of migraine headaches, even though its safety for migraine patients over 65 and under the age of 10 has not been established. However, what has been established is that Depakote can cause serious and life-threatening side effects.
There are growing numbers of reports that Depakote is associated with life-threatening pancreatitis (from both children and adult patients) and liver damage, particularly during the first six months of treatment. As well, pancreas damage has been diagnosed in some patients years after taking Depakote.
Even with label changes (December 2006) warning of risks associated with Depakote, it is one of the most-prescribed off-label drugs and widely prescribed. It is taken by patients who may be taking several other medications at the same time, by children under 10 years of age, and taken, most alarmingly, by pregnant women: Depakote has recently been linked to birth defects. On January 31, 2007, the FDA approved further safety labeling revisions to advise of the risk for congenital malformations in infants exposed to divalproex sodium during gestation. Depakote is now classed as "Category C" for pregnant women, meaning that animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.
According to the American College of Obstetricians and Gynecologists, the risk of spina bifida among infants born to mothers receiving Depakote during the first trimester is estimated to be 1% to 2%, compared to 0.14% to 0.2% in the general population. In a report by the North American Antiepileptic Drug Pregnancy Registry, Depakote use during the first trimester of pregnancy is linked to a 4-fold increased risk of congenital malformations when compared with other antiepileptic drugs (AEDs).
Abbot Laboratories, the makers of Depakote, reported an increase of 18.5 percent in overall sales of Depakote in 2006, earning the company $384 million in the 4th quarter of 2006, and $1.2 billion in 2005.
If you or a family member was prescribed Depakote and suffered serious side effects, you may want to seek legal advice. As well, if you or someone you know took Depakote while pregnant and had a child with birth defects, you may be entitled to compensation.
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