Depakote Side Effects

Depakote Linked to Birth Defects

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Depakote is a prescription medication used to treat epilepsy and manic episodes associated with bipolar disorder. Manufactured by Abbott Laboratories, Depakote (divalproex sodium and/or valproate) was released onto the market in 1983 for the treatment of epilepsy. In 1995, Depakote was approved for the treatment of manic episodes in patients suffering from bipolar disorder.

Following this success, physicians began prescribing the drug to treat migraine headaches and other neuropathy conditions. Depakote received FDA (United States Food and Drug Administration) approval in 2000. However, since giving its approval, the FDA has issued warnings on the dangers and risks of taking Depakote.

In 2006, the FDA issued a black box warning (the strongest possible warning the agency can give) for Depakote. This warning cautioned women of childbearing age that the benefits of Depakote use might be outweighed by the serious risks the medication poses to unborn fetuses. Also, the black box warning indicated that Depakote could cause liver failure or pancreatitis in some individuals.

The major side effects of using Depakote include:

• Hepatic failure (liver failure)
• Pancreatitis
• Somnolence (constant sleepiness)
• Increased risk for birth defects

The most serious of these side effects is the increased risk for birth defects in children whose mothers were using Depakote during pregnancy. Many studies have shown that antiepileptic (or anticonvulsant) medications, such as Depakote, can lead to major birth defects. A study performed at five Boston area hospitals over a 7-year period found that over 20 percent of newborns whose mothers used antiepileptic drugs, such as Depakote, during pregnancy had serious birth defects.

Furthermore, in the August 8, 2006 issue of Neurology, a study reported that major birth defects and even fetal deaths were much more likely to occur in pregnant women using Depakote than any other antiepileptic medication. This study also collected data suggesting that the toddlers of women who used Depakote during pregnancy, scored nearly 8 points lower in I.Q. testing than other toddlers whose mothers used other antiepileptic drugs.

As compared to other antiepileptic medication options, the study also found that the chances of the child being mentally retarded were double if the mother was using Depakote. This information led the Neurodevelopmental Effects of Antiepileptic study group to conclude that Depakote should be at the “bottom of the list” of recommended antiepileptic drugs.

All of the data and information gathered on the dangers of Depakote recently led the FDA to take additional action. In December 2009, the FDA issued a statement warning physicians and patients about the very serious birth defects associated with the use of Depakote during pregnancy. In an effort to assist patients in weighing these risks, the FDA now requires that a medication guide be provided with the antiepileptic drug. This guide warns patients of the many birth defects that may occur.

The types of birth defects linked to Depakote include:

• Cleft palate
• Hand deformations
• Undescended testes
• Hypospadia (opening of the urethra in the wrong place)
• Heart malformations
• Limb reduction and/or deformities
• Dysplastic (abnormally developed) ribs
• Fetal death
• Neural tube malformations
• Spina Bifida

Spina Bifida is the most common type of neural tube defect. It occurs when the embryonic neural tube is not completely formed. This neural tube malformation results in the child having an opening in the vertebrae, leaving their spinal cord exposed. This birth defect typically occurs just weeks after conception. Although most warnings have cautioned women not to take Depakote while they are pregnant, some data also suggests that women should be weary of taking Depakote after pregnancy. The drug may pass through the breast milk, causing the baby to suffer the dangerous side effects of Depakote.

The long list of birth defects is frightening. Many of these side effects are considered life threatening. Additionally, many of the possible birth defects that may occur as a result of using Depakote cannot be corrected through surgical procedures or treatments. This means that the child could potentially suffer from a non-fatal birth defect for the rest of their lives.

PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING THE USE OF DEPAKOTE OR ANY OTHER PRESCRIPTION DRUGS.

Contact the Law Offices of d'Oliveria & Associates, P.C.

If you believe that you or a loved one has suffered as a result of taking Depakote, you may want to speak with an injury attorney, today, regarding your potential lawsuit. A personal injury lawyer familiar with new developments in the investigation of Depakote may be able to help you make important personal and legal decisions.

Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.