The Food and Drug Administration (FDA) recently issued a warning that taking Depakote (divalproex sodium) or related drugs during pregnancy poses a serious risk of birth defects. The likelihood of neural tube defects is a staggering 30-80 times higher if the mother takes valproate during the first trimester, as compared to the general U.S. population. Among pregnant women taking antiepileptic drugs, the risk of birth defects is four times higher with valproate than with alternative drugs.
Valproate sodium, valproic acid and divalproex sodium are marketed as Depacon, Depakene, Stavzor or Depakote, and are used to treat epilepsy, bipolar disorder and migraines.
The most common birth defect linked to valproate is spina bifida, a condition where the spinal canal does not close properly. Other defects associated with valproate use include skull, facial, heart and other organ malformations. These conditions can be life-threatening or can require the babies to go through surgeries and extensive medical treatment.
General information on birth defects
Teratogens are substances that can cause birth defects, and are present in some prescription and over-the-counter medications. There are three ways that teratogenic drugs can cause birth defects. Some cause damage to the fetus, resulting in abnormal development. Other drugs adversely affect the placenta, which decreases the supply of oxygen and nutrients to the fetus (causing low birth weight and underdevelopment). Lastly, some drugs cause contractions which can injure the fetus or induce premature labor.
The most dangerous time for a fetus to be exposed to teratogenic drugs is during the first 3-8 weeks of the pregnancy. However, some drugs can harm the fetus at any time during the pregnancy. Drugs taken 20 days or more before conception can either have no effect, or induce miscarriage.
There are five categories the FDA uses to classify drugs according to the risk of harm to a fetus when taken during pregnancy:
- Category A - Sufficient and well-controlled studies show no evidence of risk to the fetus.
- Category B - Animal studies show no evidence of risk to the fetus; no sufficient and well-controlled studies on pregnant women.
- Category C - Studies on animals indicate a possible adverse effect on the fetus, but the drug's potential benefits may outweigh the risk. Sufficient and well-controlled studies in humans do not yet exist.
- Category D - Positive evidence of risk to human fetuses; however, the use of drug by pregnant women may still be warranted in some cases.
- Category X - Positive evidence of human fetal risk; women who are or could become pregnant should not take this drug.
- Category N - The FDA has not yet classified this drug.
The birth defect attorneys of Oshman & Mirisola, LLP has over 35 years of experience representing clients in personal injury lawsuits. If your child suffers from birth defects that may be caused by valproate, you may be entitled to damages for medical expenses, pain and suffering, and other compensation. Call us at (800) 400-8182 or fill out and submit our online Contact Us form for a free consultation. We are committed to seeking justice for you and your family.