Depakote® (Valproic Acid) and Pregnancy

If you are taking Depakote® and become pregnant or are thinking about becoming pregnant, you should speak with your doctor about the potential risks of birth defects. Data has proven there may be an increase in the risk of serious congenital malformations if Depakote® and similar medications are taken early during pregnancy.

FDA Pregnancy Warning

The U.S. Food and Drug Administration (FDA) issued a warning to alert patients and healthcare providers about an increase in the risk of major birth defects in babies whose mothers take valproate sodium and related products during their pregnancies.

The FDA warning involved Depakote®, Depakote CP®, Depakote ER® (dilvalproex sodium), Depacon® (valproate sodium), Depakene® (valproic acid) and Stavzor® (valproic acid). The medications are used for the treatment of epilepsy, bipolar disorder and migraine headaches.

According to the FDA warning, these medications increase the risk of serious birth defects, including neural tube defects, craniofacial defects and heart malformations.

FDA Pregnancy Recommendations

The FDA included the following pregnancy recommendations in the warning:

  • Women should contact their healthcare providers immediately if they become pregnant while taking valproic acid or a related medication
  • Women should talk to their healthcare providers and should not stop taking their medication unless instructed to do so
  • Women who are planning a pregnancy or who become pregnant should talk to their doctors about the potential risks of congenital defects
  • Women of child bearing age who are not planning a pregnancy should take an effective form of birth control

Despite evidence that there might be an increased risk of birth defects when taken during pregnancy, healthcare providers believe that the benefits outweigh the risks for some women. It is very important to discuss your individual circumstances with your healthcare provider without stopping treatment on your own.

If you were instructed to take Depakote® during your pregnancy and your baby is born with serious birth defects, you should speak with a Depakote® birth defect lawyer about your legal rights. For more information, please contact us today.