The agency sent a letter to neurological and obstetric health workers warning that when taken by pregnant women, valproate sodium (marketed as Depacon), valproic acid (marketed as Depakene and Stavzor), divalproex sodium (marketed as Depakote, Depakote CP and Depakote ER) and related products have been shown to increase the risk of cardiovascular malformations, craniofacial defects, neural tube defects and other major birth defects.
For example, while the risk of neural tube defects in the general population is only 1 in 1,500, it is 1 in 20 among children born to women who took Depacon during the first 12 weeks of their pregnancy. The rate of overall birth defects is nearly four times higher in women taking valproate than in women taking different anti-seizure drugs.
Because neural tube defects often develop before a woman even knows she is pregnant, the FDA emphasized that the drugs should not be used in women who are planning a pregnancy, and that birth control should be used by all women of childbearing age who are taking the drugs.
Women are considered “of childbearing age” between the onset of puberty and the end of menopause unless they have had their ovaries or uterus removed.
The drugs are currently approved for the treatment of epileptic seizures and bipolar disorder, but are often prescribed “off label” for less severe conditions such as migraine headaches. The FDA emphasized that women of childbearing age should not be prescribed valproate or related drugs except for life-threatening conditions or in cases where other treatments have been ineffective.
Untreated epilepsy or bipolar disorder can also pose a risk to developing infants. Stopping anti-seizure medications suddenly can also be dangerous. The FDA recommends that any women being treated with valproate or related products consult a doctor immediately if they become pregnant or are planning a pregnancy.
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