June 7, 2011 – According to a new study published in this week’s The Lancet Neurology medical journal, the risk of birth defects from the use of anti-epileptic medications may increase when higher doses of the drugs are taken by pregnant women. Birth defects associated with these types of drugs include neural tube defects, craniofacial defects, cardiovascular malformations and other major birth defects. Among the epilepsy drugs named in the new research are Depakote, Tegretol, Lamictal, Epitol and others.
Depakote Birth Defects Update 1/24/13: A new study has determined that Depakote can cause lowered IQ’s and other cognitive deficiencies in children born to mothers who take the drug during pregnancy. Specifically, the research found that babies exposed to Depakote in the womb had IQ’s that were seven to 10 points lower than other children at age six, as well as reduced language skills and memory capacity. Click here to learn more.
Free Epilepsy Drug Case Evaluation: If you or a loved one has given birth to a child with a congenital defect you feel may have been caused by an epilepsy medication, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
The Lancet Neurology study analyzed data on nearly 4,000 pregnancies in 33 different countries, and found that the rate of birth defects increased in women taking the following medications when they took them at high doses:
- Depakote (valporic acid)
- Tegretol (carbamazepine)
- Epitol (carbamazepine)
- Lamictal (lamotrigine)
The new study confirms previously held suspicions that women who were prescribed anti-epileptic drugs in their first twelve weeks of pregnancy – a time when many women may still be unaware that they are pregnant – could increase the risk of their child developing a life-threatening birth defect. Therefore, it may be too late for some women to quit using such medications in order to prevent their child from being born with congenital defects. Among the new study’s additional findings:
- Depakote and phenobarbital had the highest birth defects risk across all dose sizes
- Tegretol and Epitol birth defects risk increases above 400 mg a day
- The lowest birth control risk was in women taking less than 300 mg of Lamictal a day
- A family history of birth defects quadrupled a baby’s risk of being born with a congenital defect
In light of the new research, healthcare providers are advised to take into account the dose dependent nature of epilepsy drug birth defects before prescribing them to pregnant women.
Depakote Birth Defects
Depakote was once more widely prescribed, without warnings, to pregnant women until it was discovered that there was a significant risk of birth defects associated with its use. Neural tube issues are the most commonly reported birth defects resulting from the use of Depakote during pregnancy. Incidences of neural tube defects are estimated to be at 1-2% of exposed fetuses. Other birth defects can include (but are not limited to):
- Cleft palate
- Cleft lip
- Facial dysmorphism
- Congenital cardiac defects
- Limb reduction and/or other skeletal anomalies
- Spina Bifida
- Atrial septal defects (ASD)
- Ventricular septal defects (VSD)
In 2010, a European study found that Depakote increases the risk of birth defects when taken as early as the first trimester of pregnancy. The study also indicated that taking Depakote resulted in a:
- 12-fold increased risk of spina bifida
- 7-fold increased risk of craniosynostosis (abnormal skull)
- five-fold increased risk of cleft palate
- 2.5 times the risk of the baby developing an atrial septal defect (a hole in the heart).
Abbott Laboratories is currently being probed by the U.S. Department of Justice over its sales and marketing of Depakote. Federal investigators are looking into whether the company violated Medicare or Medicaid reimbursement laws. Depakote was first approved by the FDA in 1983.
Do I have an Epilepsy Drug Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in epilepsy drug lawsuits. We are handling individual litigation nationwide and currently accepting new birth defects cases in all 50 states.