Depacon, Depakote Pregnancy Warning Updated Regarding Birth Defect Risk

The FDA is updating the warning for the antimigraine and antiepileptic drug valproate sodium and related drugs, which include Depacon, Depakote, Depakene and Stavzor. Use during pregnancy can cause neural tube defects and other major birth defects.

The agency released information for healthcare professionals on December 3, alerting them that women of childbearing age should be informed that the use of these drugs could cause a wide variety of birth defects. The FDA alert said that the agency is working with manufacturers to update label warnings and develop a Medication Guide to be provided to each consumer receiving the prescription.

All valproate-based drugs are impacted by the warnings, such as Depacon (valproate sodium), Depakote (dilvalproex) and Depakene and Stavzor (valproic acid). These drugs are used to treat epileptic seizures, bipolar disorder and migraines.

The FDA looked at data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry and found that the use of valproate during pregnancy increases the risk of major birth defects and malformations. In particular, the risk giving birth to a child with a neural tube defect was 1-in-20 for women who took valproate during the first 12 weeks of pregnancy. The risk for mothers not taking valproate was 1 in 1500 in the U.S.

The NAAED Registry reported that more than 10% of women who took an average of 1,000 mg per day of Depakene or Stavzor during pregnancy gave birth to children with some kind of major malformation. Other birth defects whose risks are increased include craniofacial defects, cardiovascular malformations and malformations of other body systems.

Pregnancy problems with Depakote birth defects have been long recognized. A “black box” warning has been on the medication’s label since 2006, warning about potential Depakote birth defects associated with use of the drug during pregnancy. A study done that year found that about 20% of babies born to mothers taking Depakote suffered serious problems, as opposed to other drugs which only had rates of between 1% and 10.7.

Abbott Laboratories, the creator of Depakote, is currently being probed by the U.S. Department of Justice (DOJ) over its sales and marketing of the drug. Federal investigators are looking into whether the company violated Medicare or Medicaid reimbursement laws. Depakote was first approved by FDA in 1983. Depakene, the first drug of the class, was approved in 1978.