Houston, Texas — Babies born to women taking Depakote (valproate), the commonly prescribed anti-seizure medication, were 5 times more likely in one study, and 14 times more likely in another study, to suffer from serious birth defects and other congenital problems, including spina bifida and other neural tube defects. Furthermore, researchers also stated that women should avoid taking Depakote, if possible, during childbearing years.
In a recent study by Page Pennell, MD, of Atlanta’s Emory University School of Medicine that was presented at the American Academy of Neurology, it was shown that birth defect problems were far more common when women took Depakote during pregnancy when compared to women who took other anti-epileptic drugs.
Birth defects, developmental delays and death of the fetus occurred in 28% of children whose mothers took Depakote when compared to just 2% of children whose mothers took other anti-seizure drugs, in the case of this study, the newer drug Lamictal.
Similar complications were also noted with the use of some other anti-seizure medications during pregnancy, but not nearly to the same degree as with the use of Depakote. Among other anti-seizure drugs, only 10% of children whose mothers took Tegretol and 7% of children born to mothers who took Dilantin experienced such problems. Again, 28% of children whose mothers took Depakote suffered from spina bifida, neural tube defects or other birth defect complications.
The oldest children in this quoted study are now 8 ½, and researchers from Atlanta’s Emory University School of Medicine, say that these children suffering from Depakote induced birth defects still need to be monitored for at least a few more years to see how the serious defects and developmental differences persist or further develop.
According to the study, many women taking anti-seizure medications for epilepsy may need to consider staying on the drugs during pregnancy, since uncontrolled seizures during pregnancy may in some cases cause miscarriage. Also, the serious risk of not being able to regain control of a patient’s seizures after stopping an anti-seizure medication is always present. In many instances, this risk exists in spite of being able to restart the exact same anti-epileptic drug that was effective, at a later time.
The moral question then becomes:
“If a woman had all of the facts regarding the potentially catastrophic birth defect side effects of Depakote, like spina bifida, and fully understood the risks to her unborn child associated with the use of Depakote while pregnant, would she have chosen to use Depakote?”
The answer to that question may not be known, but most would agree that every woman is entitled to have a full knowledge of the birth defect risks associated with Depakote in making educated decisions before getting pregnant. It would be safe to assume that some family planning decisions would be greatly affected by the knowledge that Depakote has such serious risks of potentially catastrophic birth defects like spina bifida.
Knowing what we know now about the strong link between Depakote use by women while pregnant and the occurrence of neural tube birth defects such as spina bifida, pharmaceutical companies and the medical community need to ensure that pregnant women and their doctors have full access to the data related to Depakote and spina bifida.
Conventional wisdom has always been that taking seizure medication doubles a pregnant woman’s risk of having a child with birth defects. But the study showed that it is becoming very clear that certain anti-seizure drugs like Depakote carry a far greater risk of birth defects than even previously thought. When compared to the drug Lamictal, Depakote has a 10 times greater risk for serious birth defects.
“The evidence against the use of Depakote by women during pregnancy is mounting, but the message has not gotten out,” the study says. “This drug is being increasingly prescribed for other conditions like migraines, bipolar disorder, and mood disorders.”
Researchers in the study actually presented data from the five-year study a year early, because the findings were so striking.
A spokesman for Depakote manufacturer Abbott Laboratories stated that the fact that only 25 women in the study took the drug could easily have distorted the findings.
“Depakote has been around for more than 20 years, and more than 3 million people have been treated with it,” said the spokesman for Abbott Labs. “Untreated epilepsy has potentially serious or fatal consequences for both the mother and the child.”
Another study has also shown greatly increased rates of problems in children whose mothers took Depakote during pregnancy. This research will be presented in Vancouver this summer at a meeting of birth defect specialists.
In this latest study investigators followed 149 women with epilepsy who took Depakote, from early on in their pregnancies through the period following their deliveries.
In that study, it was found that among mothers who took Depakote, 11% had children with birth defects, the most common of which was spina bifida, a neural tube defect in which spinal cord development is incomplete or deformed. The same type of spina bifida and other neural tube defects were seen in only 3% of children of pregnant women taking all other anti-seizure drugs studied combined. In this same study, less than 2% of children born to mothers without epilepsy had similar congenital birth defects. The results of this study point to a 500% greater risk for birth defects or other complications when pregnant women took Depakote during their pregnancies.
According to this latest study, all pregnant women who were taking Depakote also either took a prenatal multivitamin and/or folic acid supplements during the term of their pregnancies. It is generally recommended that women who are pregnant or might become pregnant take 400 micrograms of folic acid daily to prevent spina bifida. According to the researchers in this study, women taking Depakote may actually need to take more than 10 times that amount of folic acid to possibly try and counter the effects of Depakote, although this has not been definitively proven yet.
“There is no question in my mind that Depakote causes birth defects,” stated Dr. Wyszynski of the study. “Women who do not have to take it shouldn’t, but those who do may be able to decrease the risk of spina bifida birth defects in their children by taking higher doses of folic acid.”
According to representatives at the American Epilepsy Foundation, the good news from the Pennell study is that it showed a much lower rate of spina bifida and other birth defect problems and complications seen with the use of some of the newer anti-seizure medications. As previously stated in this article, sixty women in the Pennell study took the newer drug Lamictal, with only 2% of their children having the same birth defect problems that occurred in a full 28% of children born to pregnant mothers taking Depakote during their pregnancies. The fact still remains that in Pennell study, there was shown to be a 1400% greater risk of suffering birth defects and other complications associated with the taking of Depakote by women while pregnant than there was associated with taking a newer medication like Lamictal. Restated, that represents 14x greater risk of birth defects with Depakote.
“We have been suspicious for some time that our full appreciation of the potential adverse effects of various anticonvulsive drugs on fetal development has not been completely understood. Studies like this one [the Pennell Study] are exactly what we need to get as close to the truth as we can” — Daniel Lowenstein, President of the American Epilepsy Foundation
There are great differences between an individual Depakote (valproate) Spina Bifida lawsuit and a Depakote Spina Bifida class action lawsuit.
In most instances, a Depakote Spina Bifida lawsuit that involves severe birth injuries is better served by having a lawyer file an individual Depakote Spina Bifida lawsuit. In an individual Depakote Spina Bifida lawsuit, the plaintiffs’ cases are filed by a lawyer and presented on their own merit, individually.
In class action Depakote Spina Bifida lawsuits, a group of victims typically are joined to form a “class”, which in this case a lawyer would bring to court as a class action lawsuit against Abbott Laboratories, the manufacturer of Depakote (valproate). All potential Depakote Spina Bifida plaintiffs would be grouped into a single Depakote Spina Bifida class action lawsuit, regardless of the severity of spina bifida or neural tube injuries. Depakote victims in a Depakote Spina Bifida class action lawsuit would then only share any resulting settlements or awards from the Depakote Spina Bifida class action lawsuit.
On the other hand, individual Depakote (valproate) Spina Bifida lawsuits filed by lawyers allow each Depakote Spina Bifida plaintiff to have their own individual case considered on an singular basis when damages, awards and settlement figures are considered. In individual Depakote Spina Bifida lawsuits, awards or settelments are based on an individual victim’s current spina bifida injuries and all of their future and potential spina bifida needs, and not as part of a grouped class action lawsuit.
If you took Depakote (valproate) or any other anti-seizure drug during pregnancy and your child was born with a Spina Bifida birth defect, please contact a Depakote Spina Bifida Litigation Attorney at our law firm immediately. While it may be too late to recover from all of the devastating effects of Depakote an experienced products liability pharmaceutical lawsuit lawyer at the Willis Law Firm can assist you in any legal action against Abbott Laboratories, the maker of Depakote. You are not alone. Join other Depakote Spina Bifida and other neural tube birth defect victims and their families in speaking up and fighting for your legal rights.
Please fill out our free online legal evaluation form and we will contact you within 24 hours. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that you can speak to a Depakote lawyer and so that we may explain the rights and options available to you and your family.