Several studies have shown that the use of Depatkote (divalproex sodium) in pregnant women significantly increases the risk of birth defects, including: spinal bifida, cleft palate, hypospadia, heart deformities, facial dymorphism , limb reduction and skeletal defects. Depakote is marketed by Abbott Laboratories and is approved for the treatment of manic episodes associated with bipolar disorders and seizure disorders like epilepsy.
In December 2009, the FDA notified healthcare professionals that they should inform women of childbearing age that that the use of Depakote could cause a wide variety of birth defects. After reviewing data of pregnant women taking Depakote, the FDA found that the use of Depakote during pregnancy significantly increases the risk of birth defects. In fact the analysis found that women taking Depakote during the first 12 weeks of pregnancy had a 1-in-20 chance of having a child with a neural tube defect versus 1-in- 1500 for women not taking the drug.
The risk of Depakote during pregnancy was much greater than any other antiepileptic drug. The risk of a major malformation in babies of women taking Depakote while pregnant was 10.7% versus 2.9% in babies of women taking other epilepsy medications. Depakote is currently listed as a pregnancy category D medication by the FDA which means there is positive evidence of fetal harm.
Depakote Birth Defects:
- Spinal bifida
- Cleft palate
- Hypospadia
- Heart deformities
- Facial dymorphism
- Limb reduction
- Skeletal defects
