This page was written in nine years ago but it has 2024 updates in it. We talk about a lot related to Depakote, including the link it could have to autism.
Depakote
Depakote is not exactly a new drug considering that it was approved by the FDA back in 1978. Since then, it has been approved to treat epileptic seizures and convulsions. The drug soon found itself on the FDA’s radar, prompting them to issue a Black Box warning alerting both patients and doctors of the potential birth defects that the drug may cause. A few years later the FDA specifically warned patients about the possibility of neural tube defects, heart defects, and craniofacial birth defects, while also warning about suicidal thoughts and actions associated with Depakote use. Still, the drug was making too much money for Abbott to voluntarily recall.
A 2010 study really put the nail in the coffin for the drug, confirming that the risk of spina bifida increased nearly twelve-fold for children of women who were taking Depakote at the time of pregnancy. And in 2011 the FDA issued another warning, claiming that there was a correlation between Depakote and diminished cognitive abilities. The warning suggested that children born to mothers who were on the drug also have lower IQs.
The drug was a huge cash cow for AbbVie and Abbott Laboratories, generating around $1.5 billion in sales each year. But considering how closely Depakote was linked to birth defects and other conditions, it is likely that the verdict, in this case, will not be AbbVie’s last for the drug. Millions of people were prescribed Depakote. Unfortunately, the damage has already been done.
The Problem with Depakote
Depakote is a known human teratogen. Plaintiffs’ lawyers allege that it is associated with a number of congenital malformations and cognitive deficits. Possible harmful effects include heart defects, hydrocephalus, craniofacial defects, spinal Bifida, microcephaly, heart defects, limb, and digital defects, urogenital defects, cleft lip and palate, decreased IQ, mental retardation, and developmental delay.
When do these injuries happen? Early in the pregnancy. These malformations generally occur in the first nine weeks of gestation. Depakote specifically affects cells and neurons, including those which develop the brain, face, and limbs. The thumbs are completely formed by sixteen weeks, but the absolute dysmorphia occurs in the first nine weeks.
After years on the market, the FDA required Abbott to include a “Boxed Warning” alerting doctors and patients – most notably, mothers and women of childbearing age who might become pregnant – of the risk of birth defects as a result of Depakote use. There are also risks on the box now about hepatotoxicity and pancreatitis. These are serious and potentially fatal conditions.
Depakote lawsuits that involve birth defects such as spina bifida, craniofacial defects, cardiovascular malformations, and similar malformations in young children whose moms were taking Depakote when they were pregnant.
A Verdict
A Missouri jury awarded $15,ooo,ooo to the family of a girl who was born with spina bifida, finding that the drug Depakote led to her condition. Specifically, the suit alleged that AbbVie, who also manufactures drugs like AndroGel, failed to sufficiently warn pregnant mothers who were on the drug about the risk of birth defects.
This specific lawsuit was a product liability action brought by a 12-year-old girl and her family after she experienced health problems throughout her entire life. They alleged that AbbVie failed to adequately warn pregnant women about the correlation between Depakote and birth defects. The $15,000,000 verdict is comprised of compensatory damages for the girl’s medical care (which will be required throughout her entire life), along with pain and suffering, and other costs. There is actually a possibility that AbbVie could be responsible for paying millions more in punitive damages in the second phase of the trial that will determine whether AbbVie recklessly endangered the lives of unborn children.
This isn’t the only Depakote lawsuit floating around the judicial system either. Numerous families have raised similar allegations against AbbVie, claiming that the drug has caused all manner of birth defects. Depakote has actually kept AbbVie’s legal department fairly busy considering that the United States government launched an official investigation into the drug being used off-label. The investigation stemmed from allegations of health care fraud when AbbVie marketed the drug as a cure for aggression and agitation in the elderly. Not to worry though, the company pled guilty to all the criminal and civil allegations and forked over $1.5 billion to the federal and various state governments to make it all go away.
Depakote and Autism
Depakote use during pregnancy has been linked to an increased risk of developmental disorders, including autism, in children. The literature on this subject highlights several key points:
- Increased Risk of Autism: Research has shown that children born to mothers who took valproate during pregnancy are at a higher risk of developing autism spectrum disorders. A significant study published in the Journal of Neurology, Neurosurgery, and Psychiatry in 2013 found that children exposed to valproate in utero were significantly more likely to develop autism and other neurodevelopmental disorders.
- Neurodevelopmental Delays: Aside from autism, exposure to valproate during pregnancy is also associated with other neurodevelopmental delays. These can include lower IQ and cognitive functions, which have been documented in various studies.
- Regulatory Warnings and Recommendations: Due to these risks, regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued warnings regarding the use of valproate during pregnancy. They recommend that valproate should not be used during pregnancy whenever possible, especially for conditions not considered life-threatening.
- Mechanisms of Impact: The exact mechanism by which valproate influences fetal development is not fully understood, but it is believed to involve alterations in gene expression and inhibition of histone deacetylase, which play crucial roles in brain development.
- Clinical Guidelines: As a result of these findings, clinicians are advised to weigh the benefits and risks of prescribing valproate to women of childbearing age and to consider alternative treatments where possible. There is also a strong emphasis on using effective contraception in women who are prescribed valproate.
These conclusions are based on a body of evidence from observational studies, clinical trials, and meta-analyses, underscoring the need for careful management and discussion of treatment options for women who may become pregnant.
More Depakote Information
Specifically, there is data suggesting that:
- Infants whose mothers took Depakote during the first trimester were more than 12 times more likely to have spina bifida than mothers who were not on Depakote; (Note: all of this data is for valproic acid. Valproic acid is the active and key ingredient in Depakote.)
- Babies whose mothers took Depakote were also 2.5 times more likely to have a heart defect;
- Depakote users who became pregnant were five times as likely to have a baby with a cleft palate or a penis abnormality;
- Children of moms on Depakote were more than two times as likely to have an extra digit on their hand; and
- Mothers on Depakote are seven times – seven times – more likely to have a premature fusion of the skull during fetal development which limits brain growth.
- They found women who took Depakote early in their pregnancy had two to 12 times the risk of having a baby with one of six specific birth defects compared to women who took no epilepsy drugs.
Can you see why plaintiffs’ lawyers are predicting a lot of Depakote lawsuits? You would think there would have been a recall. But instead of a recall – which still has not happened – this problem has festered on for years. How on earth is this possible? I have no idea. Ultimately, this may prove to be the tip of the iceberg in terms of birth defects from Depakote.
Let’s make matters worse. The United States is investigating Abbott for federal violations of impermissible off-label marketing of Depakote as a treatment for agitation and aggression in the elderly, and health care fraud arising out of that allegedly improper use. So not only were they not keeping us abreast of the real risks, they may have been pushing Depakote for uses that were not approved by the FDA.
If your child has suffered a birth injury and you or the child’s mother was taking Depakote, do two things: (1) tell the FDA and (2) call a lawyer to get more information. Are we handling Depakote lawsuits in 2024? We are not.
Have you had a good or bad experience with Depakote? Let us all know by making a comment in the space below.