Fetal valproate syndrome

Fetal valproate syndrome (FVS) may be caused by exposure of a developing baby to valproic acid when a pregnant woman takes it during pregnancy. The risk for the baby to have one or more of the major birth defects associated with FVS is highest if exposure occurs during the first trimester, especially if the mother is taking doses greater than 800 mg/day. This is because the brain and spinal cord, heart, facial features, bones, muscles, and genitals all begin to develop in the first trimester.

Fetal valproate syndrome (FVS) is often suspected in an infant who has one or more of the signs and symptoms associated with FVS and whose mother reports having taken valproic acid during the pregnancy. There is no test that can confirm the diagnosis of FVS, instead other possible causes of the signs and symptoms seen in the baby must be ruled out.

Fetal valproate syndrome (FVS) may occur if a developing baby is exposed to valproic acid during pregnancy. Valproic acid, also known as valproate, is a medication that is often used to treat epilepsy, bipolar disorder, and migraines. Many babies who are exposed to this medication during pregnancy are born healthy with normal growth and development. However, studies have found that women who take valproate during pregnancy have a greater chance of having a baby with a major birth defect or other health problem. Symptoms of FVS vary but may include characteristic facial features, spina bifida, congenital heart defects, cleft lip and/or cleft palate, genital abnormalities, skeletal abnormalities, and developmental delay. A child exposed to valproic acid may be at a higher risk for learning and behavioral problems. Although there is no cure for FVS, many of the possible signs and symptoms of FVS do have treatments or therapies available. Early intervention programs may also be helpful.

The U.S. Food and Drug Administration (FDA) advises that valproate and related products should not be taken by women for the prevention of migraine headaches during pregancy. With regard to valproate use in pregnant women with epilepsy or bipolar disorder, valproate products should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable. However, it is important to note that women who are pregnant and taking a valproate medication should not stop their medication but should talk to their doctor or other trusted medical professional immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby. For example, the sudden discontinuation of valproate in pregnant women with seizures can result in persistent seizures, which can cause harm, including death, to the mother and/or the unborn baby.

The FDA suggests a pregnant woman taking valproate or other anti-seizure medication should talk to her doctor or other trusted medical professional about registering with the North American Antiepileptic Drug Pregnancy Registry. The purpose of this registry is to collect information about the safety of anti-seizure medications during pregnancy. A pregnant woman taking anti-seizure medication can enroll in this registry by calling 1-888-233-2334. You can read more about the registry on the North American AED (Antiepileptic Drug) Pregnancy Registry website.

It is suggested that physicians refer pregnant patients who are using valproate to register for an antiepileptic drug registration program called North American Antiepileptic Drug (NAAED) Pregnancy Registry: http://www.aedpregnancyregistry.org/

The treatment of fetal valproate syndrome (FVS) is based on the signs and symptoms present in each baby or child. Management often involves a team of medical specialists and may include:

• Birth defects such as spina bifida and other neural tube defects, congenital heart defects, and cleft lip and/or cleft palate may require surgery shortly after birth
• Long-term follow-up to detect and treat early behavioral or developmental issues
• Early speech therapy, occupational therapy, and/or physical therapy
• Extra assistance at school