Depakote FDA Warning
Pregnancy
Teratogenic Effects: Pregnancy Category D.
Use of Depakote ER during pregnancy can cause congenital malformations including neural tube defects. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Depakote ER should be considered for women of childbearing potential only after the risks have been thoroughly discussed with the patient and weighed against the potential benefits of treatment.
Congenital Malformations
The North American Antiepileptic Drug Pregnancy Registry reported 16 cases of congenital malformations among the offspring of 149 women with epilepsy who were exposed to valproic acid monotherapy during the first trimester of pregnancy at doses of approximately 1,000 mg per day, for a prevalence rate of 10.7% (95% CI 6.3%-16.9%). Three of the 149 offspring (2%) had neural tube defects and 6 of the 149 (4%) had less severe malformations. Among epileptic women who were exposed to other antiepileptic drug monotherapies during pregnancy (1,048 patients) the malformation rate was 2.9% (95% CI 2.0% to 4.1%). There was a 4-fold increase in congenital malformations among infants with valproic acid-exposed mothers compared with those treated with other antiepileptic monotherapies as a group (Odds Ratio 4.0; 95% CI 2.1 to 7.4). This increased risk does not reflect a comparison versus any specific antiepileptic drug, but the risk versus the heterogeneous group of all other antiepileptic drug monotherapies combined. The increased teratogenic risk from valproic acid in women with epilepsy is expected to be reflected in an increased risk in other indications (e.g., migraine or bipolar disorder).
The strongest association of maternal valproate usage with congenital malformations is with neural tube defects (as discussed under the next subheading). However, other congenital anomalies (e.g. craniofacial defects, cardiovascular malformations and anomalies involving various body systems), compatible and incompatible with life, have been reported. Sufficient data to determine the incidence of these congenital anomalies are not available.
Neural Tube Defects
The incidence of neural tube defects in the fetus is increased in mothers receiving valproate during the first trimester of pregnancy. The Centers for Disease Control (CDC) has estimated the risk of valproic acid exposed women having children with spina bifida to be approximately 1 to 2%. The American College of Obstetricians and Gynecologists (ACOG) estimates the general population risk for congenital neural tube defects as 0.14% to 0.2%.
Tests to detect neural tube and other defects using currently accepted procedures should be considered a part of routine prenatal care in pregnant women receiving valproate.
Evidence suggests that pregnant women who receive folic acid supplementation may be at decreased risk for congenital neural tube defects in their offspring compared to pregnant women not receiving folic acid.
Whether the risk of neural tube defects in the offspring of women receiving valproate specifically is reduced by folic acid supplementation is unknown. Dietary folic acid supplementation both prior to and during pregnancy should be routinely recommended to patients contemplating pregnancy.
Other Adverse Pregnancy Effects
Patients taking valproate may develop clotting abnormalities. A patient who had low fibrinogen when taking multiple anticonvulsants including valproate gave birth to an infant with afibrinogenemia who subsequently died of hemorrhage. If valproate is used in pregnancy, the clotting parameters should be monitored carefully. Patients taking valproate may develop hepatic failure. Fatal hepatic failures, in a newborn and in an infant, have been reported following the maternal use of valproate during pregnancy.
Nursing Mothers
Valproate is excreted in breast milk. Concentrations in breast milk have been reported to be 1-10% of serum concentrations. Because of the potential for adverse reactions in a nursing infant, a decision between the physician and the patient should be made on whether to discontinue nursing or consider an alternative drug treatment for the mother, as appropriate.
Speak to a Depakote Lawyer
The Willis Law firm has represented clients in Pharmaceutical Product Liability and Personal Injury litigation for over 25 years. We thoroughly understand the pharmaceutical industry and pharmaceutical product-liability drug litigation. You are not alone. If your child was born with Spina Bifida or other major congenital neural tube and skeletal malformations that may have resulted from your being prescribed and taking Depakote during pregnancy, please contact our law firm immediately to discuss your legal options. Please keep in mind that certain states have a statute of limitations regarding the amount of time you have to seek legal action.
The Willis Law Firm has been responsible for recovering significant settlements and verdicts for our clients. Financial recoveries can never bring back a loved one, but can help families deal with the financial stress associated with a life-changing injury or illness. They may also help prevent similar injuries to others in the future by holding pharmaceutical companies responsible today. Consulting a skilled and experienced pharmaceutical products-liability attorney is your first step in receiving the justice you and your family deserve. Contact us today for a free and confidential Depakote side effects lawsuit evaluation.
