Depakote Birth Defects

Depakote (also known as valproate semisodium or divalproex sodium) is a popular drug used to treat epilepsy and manic episodes of bipolar disorder. Unfortunately, there are many Depakote side effects associated with the anti-convulsant such as spina bifida that have resulted in Depakote lawsuits, including a class action lawsuit in the UK. The Food and Drug Administration classified Depakote into pregnancy category D due to its likelihood of causing serious and potentially life-threatening birth defects.


The most dangerous Depakote side effects involve damage to the unborn fetus. Consequently, women who are pregnant, likely to become pregnant, or are nursing should not take Depakote because it can cause the following conditions:

Depakote and Birth Defects:

The most dangerous side effects of Depakote involve damage to an unborn fetus. These side effects include:

• Cleft palate
• Hypoplastic right heart ( a condition that results in an underdeveloped right side of the heart)
• Undescended testes
• Hand malformations
• Dysplastic (abnormally developed) ribs
• Hypospadia (a condition in male babies that causes the opening of the urethra to occur in the wrong place)
• Spina Bifida (a condition that results in the spinal column failing to completely enclose the spinal cord.
• Fetal death

Spina Bifida
The most serious side effects of Depakote involve birth defects. The use of valproic acid during pregnancy, particularly during the first trimester, has been associated with a number of fetal abnormalities. Spina bifida is a birth defect in which the spinal cord and backbone fail to develop or close properly. The risk of spina bifida in the offspring of mothers taking valproic acid during pregnancy is 1 percent – 2 percent. A recent study found that babies subjected to their mothers' use of valproic acid during the first trimester were 12.7 times more likely to have spina bifida compared to babies whose mothers did not take the drug.

Depakote Studies

A study conducted over a period of seven years at five Boston area hospitals, involving more than 1,000 single births, determined that more than 20 percent of infants whose mothers had taken an anticonvulsant during pregnancy—including Depakote--had major birth defects. Babies born to mothers who had taken more than one anticonvulsant during their pregnancy were 24 percent more likely to have fetal trauma, while underdosed women only suffered 9.1 percent likelihood of birth defects.

The study found that spina bifida, a serious condition where the back of the spine is left open, endangering the spinal cord, was the most common birth defect found when mothers had taken both carbamazepine and valproic acid (Depakote), two drugs frequently used as mood stabilizers.

Meanwhile, a small British study, published in the Journal of Neurology, Neurosurgery & Psychiatry (1/30/13), suggests women who take valproate while pregnant have an increased risk of having children with autism and neurodevelopment problems. Furthermore, the study suggests that damage to the fetus happens during the early stages of pregnancy.

Health professionals have warned about Depakote side effects for almost a decade. In April 2001 the New England Journal of Medicine. reported that the frequency of major malformations, growth retardation, and hypoplasia of the midface and fingers, known as anticonvulsant embryopathy, is increased in infants exposed to anticonvulsant drugs in utero. "A distinctive pattern of physical abnormalities in infants of mothers with epilepsy is associated with the use of anticonvulsant drugs during pregnancy, rather than with epilepsy itself," the study concluded.

The Neurodevelopmental Effects of Antiepileptic Drugs study group reported that Depakote (valproate) should be "at the bottom of the list" when prescribing antiepileptic drugs for pregnant women with epilepsy. Neurology (August 8, 2006) reported that major congenital malformations and fetal deaths were significantly more common in pregnancies of women taking Depakote compared with other antiepileptic drugs, and the effect of Depakote was dose-dependent.

These reports are of serious concern to bipolar women because some of the epilepsy medications involved in this study are also used as mood stabilizers, and women who take any of these drugs for migraine headaches should also be aware of Depakote side effects.

Depakote is manufactured by Abbott Pharmaceuticals Ltd. Divalproex sodium has been on the market since 1983 as Depakote; there are several generic forms of it manufactured by (among others) Mylan, Dr. Reddy's Laboratories, Lupin Pharmaceuticals, Sandoz, Sun Pharmaceutical Industries and Teva Pharmaceuticals USA.

Depakote Lawsuits

While Depakote has been marketed as a treatment for psychiatric conditions, a similar drug called Epilim, which is used in the UK and also contains sodium valproate, has been marketed for epilepsy. A class action suit is underway in the UK involving Epilim, brought by parents who claim their children have been disabled by the anti-convulsant drug. Birth defects range from cleft palate and spina bifida to learning difficulties and behavioral problems.

If your child suffers from the side effects associated with Depakote, including spina bifida, a cleft palate or any other malady, Defakote attorneys advise that you schedule an appointment with your doctor to fully evaluate your child's condition and document the diagnosis, prognosis and if possible, the expected costs associated with the treatment your child will need throughout his or her life.

If you or someone you know is the victim of Depakote birth injury side effects, you may be entitled to financial compensation for pain and suffering Please click the link below to send your Depakote birth defects complaint to an attorney who will evaluate your claim free of charge.

Depakote Side Effects Legal Help

If you or a family member have taken Depakote and have subsequently had a child with birth defects, you may be eligible for compensation. Please fill in our form to send your complaint to a lawyer who will review your claim at no charge.
Last updated on May-7-15