Depakote, known generically as valproate semisodium, was approved by the US Food and Drug Administration (FDA) in 1983 for the treatment of epileptic seizures and various other psychological disorders, including but not limited to bipolar disorder. Beyond the approved indications, however, Depakote is also prescribed off-label for the treatment of migraine headaches and symptoms of aggression in the elderly.
Like all medications, Depakote is effective in association with the indication(s) for which it is approved and prescribed. However, side effects can vary in severity, and those adverse reactions affecting women during pregnancy are alleged to have had, in some cases, dire consequences on the fetus while in the womb.
The concern remains greatest during the first trimester of a woman's pregnancy.
The Depakote lawsuit, filed March 22 in St. Clair County Circuit Court, accuses Depakote manufacturer Abbott Laboratories of misleading doctors and other medical professionals as to the true risks of the drug, together with an accusation that Depakote is a defective drug. Negligence on the part of Abbott Laboratories is alleged.
READ MORE DEPAKOTE BIRTH DEFECT LEGAL NEWS
Various other lawsuits accuse the manufacturer of intentionally omitting the potential risk of birth defects from the product warning label. Birth defects alleged to be associated with Depakote range from cleft palate to spina bifida, the latter thought to be one of the most severe alleged Depakote side effects and one of the most disabling of the possible birth injuries. Additional Depakote side effect injuries include growth malformation, skeletal defects, hydranencephaly, iniencephaly, fetal valproate syndrome and fetal death.
Depakote has been classified by the FDA under pregnancy category "D" due to the potential for serious Depakote birth defects that could haunt a child for an entire lifetime.