Valproic Acid Birth Defect Risks - Consumer Justice Foundation

Valproic Acid Birth Defect Risks

Written by Faith Anderson on June 29, 2011

Valproic acid, or Depakote, is an anticonvulsant drug approved for the treatment of epilepsy, seizures, migraine headaches, and the manic phase of bipolar disorder. The drug was approved by the FDA in 1983 and has remained one of the most frequently prescribed antiepileptic drugs since. Depakote functions by inhibiting the firing of certain impulses in the brain, thereby reducing the frequency and intensity of seizure-related disorders. Depakote is currently manufactured by pharmaceutical company, Abbott Laboratories.

Valproic Acid (Depakote) Use in Pregnancy

Researchers involved in this study reviewed eight previous studies which observed nearly 1,600 births and identified about fourteen birth defects that seem to be significantly more prevalent among infants exposed to valproic acid (Depakote) during pregnancy. The researchers then used this information to analyze data from a large European study which included nearly four million births and 98,000 birth defects, from which they concluded that children born to women who take valproic acid during the first trimester of pregnancy are much more likely to have serious birth defects affecting the heart, brain and limbs.

According to the NEJM study, infants whose mothers took valproic acid during the first trimester of pregnancy were 12.7 times more likely to develop spina bifida compared to infants who were not exposed to the drug in utero. Spina bifida is a neural tube birth defect caused by the failure of a child’s neural tube to close properly during fetal development. The neural tube is the precursor to the child’s central nervous system, which consists of the brain and spinal cord, and is an integral component of a child’s ability to function properly after birth. Babies exposed to valproic acid in utero were also 2.5 times more likely to be born with heart defects (atrial and ventricular septal defects), nearly five times as likely to have a cleft palate or hypospadias, more than twice as likely to be born with an extra digit on the hand (polydactyly), and nearly seven times as likely to have craniosynostosis.

Alternatives to Valproic Acid May be Safer

Depakote (valproic acid) has been classified by the FDA as a pregnancy category D medication, which means there is positive human evidence of the drug’s potential to cause serious harm to a fetus when taken during pregnancy. Given mounting evidence of the risks of fetal exposure to valproic acid, researchers have urged women of childbearing age to try alternative drugs to control their seizures. Most of the malformations potentially linked to valproic acid (Depakote) occur during the first trimester of pregnancy, before many women are even aware they are pregnant. And, because nearly half of all pregnancies are unplanned, all women of childbearing age taking valproic acid may be at risk of unknowingly causing irreversible harm to their unborn child.

Because of this potential danger, Dr. Meador, a professor of neurology at Emory University in Atlanta and head researcher of another NEJM study linking valproic acid to lower IQ scores in young children, declared that valproic acid should not be used as a first-line drug for treating epilepsy in women of childbearing age. Women currently taking valproic acid (Depakote) who are pregnant or planning to become pregnant should consult their physician immediately. The FDA has advised physicians to avoid prescribing valproic acid to pregnant women unless the possible benefits of the treatment justify the potential risks to the fetus. This concern is echoed by the American Academy of Neurology, which recommends that pregnant women seek safer alternatives to Depakote for treating their medical conditions.

Legal Help for Victims of Potential Valproic Acid Birth Defects

Despite the risk of serious birth defects potentially associated with the drug, valproic acid (Depakote) remains on the market, available to millions of consumers across the country. In fact, as of 2006, valproic acid was the second most commonly prescribed anticonvulsant drug available in the U.S. If you took valproic acid during pregnancy and your child was born with a serious birth defect, contact a Depakote attorney as soon as possible. Your child may be entitled to lifetime care or financial compensation for his injuries, which you can collect by filing a Depakote lawsuit against Abbott Laboratories. Pharmaceutical drugs should never harm mothers or their children when taken during pregnancy. Unfortunately, there are some drugs currently on the market for which the potential risks may actually outweigh the possible benefits. Only when they are aware of all risks and benefits associated with their prescription medications can consumers make educated decisions about which drugs are safe for them to take. With the help of a Depakote lawyer, victims of alleged valproic acid birth defects can protect their rights and collect the compensation they deserve.

Posted Under: FDA - Food and Drug Administration
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