Depakote Increases Risks of Birth Defects

(May 2, 2012) – Depakote is an anti-seizure drug manufactured by Abbott Laboratories, designed for the treatment of epileptics and individuals with manic behavior associated with bipolar disorder. In more recent years, Depakote has also been used for migraine headaches.

The U.S. Food and Drug Administration (FDA) warned that Depakote (divalproex sodium or valproate) is a major teratogen (an agent that increases the incidence of abnormal prenatal development). Exposure to Depakote drastically increases the risk of neural tube defects, such as spina bifida.  Children with spina bifida were exposed to Depakote in utero. These children have a lifetime of special needs. According to the FDA, “the risk of neural tube defects is much higher in babies born to mothers treated with valproate during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies…The rates for neural tube defects in babies exposed to valproate during the first trimester are 30-80 times higher than the rate for neural tube defects in the general U.S. population.”

Depakote received the FDA’s Black-Box Birth Defect Warning, the most serious type of warning that can be placed on a  drug label.

Depakote was originally approved in 1978 for the treatment of epilepsy. Approvals for similar drugs followed for Depakote CP, Depakote Extended Release, Depakene, Depacon, and Stavzor. Divalproex sodium has been on the market since 1983 as Depakote; there are several generic forms manufactured by Mylan, Dr. Reddy’s Laboratories, Lupin Pharmaceuticals, Sandoz, Sun Pharmaceutical Industries and Teva Pharmaceuticals, USA.

For years there has been controversy over Depakote because of its serious side effects. It is known to contribute to liver damage in patients who have liver problems or in children being treated for seizures. But the most serious side effect of Depakote is the increased risk for birth defects in children born to women who used the medication during their pregnancy.

The FDA ordered a black box warning for Depakote packaging, suggesting that women who are pregnant or considering pregnancy find an alternative treatment to Depakote. Data suggests a definite increased incidence of congenital malformations among the children of women with epilepsy receiving valproate during pregnancy, compared with those who do not receive antiepileptic drugs (AEDs) and those who receive other AEDs.

Depakote and Spina Bifida

The most serious congenital side effect associated with Depakote is spina bifida, a malformation or incomplete formation of the embryonic neural tube. The result is an infant born with incomplete spinal formation, allowing exposure of the spinal cord.

Depakote Side Effects

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:

–       spina bifida (a condition that results in the spinal column failing to completely enclose the spinal cord

–       cleft palate/cleft lip

–       undescended testes

–       hand malformations (missing or extra fingers or toes)

–       dysplastic (abnormally developed) ribs

–       hypospadias (a condition in male babies that causes the opening of the urethra to occur in the wrong place

–       fetal death

Cleft Lip

Depakote Birth Defects

Various studies have found a link between Depakote use by pregnant women and the presence of birth defects thought to have been caused by the anti-convulsant. The FDA included Depakote on a list of drugs linked to severe birth defects, such as holes in the heart, abnormal skull formation, cleft lip/cleft palate and spina bifida.

A cleft lip or cleft palate can be surgically repaired. In most cases, patients are left with a scar and difficulty with speech. Eventually males will grow facial hair and this will help conceal the scars on the outside, but women do not have this option. The emotional scars are not as easy to hide. Unfortunately, society puts a lot of clout into outer appearances. When this happens due to the negligence of a drug manufacturer, the outcome can be devastating, and leads to a Depakote lawsuit.

Researchers at University of Groningen in the Netherlands found that babies subjected to their mother’s 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. Babies whose mothers took valproic acid were also 2.5 times more likely to have an atrial septal defect (which involves the heart), about 5 times as likely to have a cleft palate (a defect of the upper lip and roof of the mouth) or hypospadias (a penis abnormality), more than twice as likely to be born with an extra digit on the hand (polydactyly), and nearly 7 times more likely to have craniosynostosis (premature fusion of the skull during fetal development that restricts skull and brain growth). The review is published in the June 10 issue of the New England Journal of Medicine.

Previous research has also linked valproic acid to spinal bifida, other birth defects and cognitive problems in children, says  Dr. Kimford Meador, professor of neurology at Emory University in Atlanta.

In April 2009, Meador was the lead author of a study that appeared in the New England Journal of Medicine that linked exposure to valproic acid in the womb to lower IQ scores in children at the age of 3.  The American Academy of Neurology recommends avoiding the use of valproic acid in pregnant women, according to the article. Despite such concerns, valproic acid is often still prescribed, Meador said. In 2006, valproic acid was the second most commonly prescribed epilepsy drug, he noted.

There is currently a case against Abbott Laboratories alleging that Depakote during the first trimester of pregnancy caused her son to be born with hypospadias.  This is a penile defect in which the urethra of the male is deformed, usually growing on the underside of the penis. They are seeking damages for product liability and negligence. Is this justice?

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