Severe Birth Defects May Be Dependent On The Dosage Of Epilepsy Medications

In a recent edition of The Lancet Neurology, an international team of researchers conducted a study that involved four of the most widely used epilepsy medications on the U.S. market. Their findings have added an unprecedented weight to the long-suspected link between epileptic drugs and their inherent ability to increase the risk of severe, life-threatening birth defects when taken in the early stages of pregnancy.

The study acknowledges that these popular medications may impose an even greater risk when the dosage is increased. The epilepsy medications that have garnished the recent onslaught of public scrutiny consist of carbamazepine (Tegretol, Epitol), lamotrigine (Lamictal), valproic acid (Depakote), and phenobarbital. All of which have shown a significant increase in birth defects when used at higher doses.

These findings should come at no surprise to the healthcare community. Over the past few years, Depakote (generic: valproic acid) had been labeled as a dangerous solution for women with epileptic tendencies that are, or may become, pregnant. In particular, studies indicated that Depakote could potentially increase the risk of women giving birth to children with birth defects.

However, those studies did not take into account influential factors such as dosage, family history, or even the severity of the epileptic episodes. In the latest publication ofThe Lancet Neurology, Dr. Torbjorn Tomson, of the Karolinska Institute in Stockholm, Sweden, stated that “Present guidelines caution on the use of valproic acid during pregnancy, but offer little guidance on alternative options and how to manage women whose seizures cannot be controlled by other drugs.”

The 11 year study included data from the International Registry of Antiepileptic Drugs and Pregnancy on nearly 4,000 pregnancies in 33 countries. In all, 230 pregnancies resulted in major birth defects by the end of the first year after birth. However, the greatest risk to the fetus was seen with the highest doses of valproic acid (1,500 mg a day or more) and phenobarbital (150 mg or more a day), the researchers said. Accordingly, those with a family history of birth defects were at an even greater risk of developing severe complications.

Dr. W. Allen Hauser, a professor of neurology and epidemiology at Columbia University in New York City added that “the findings are important to the clinician treating people with epilepsy because they provide specific information not only on the drug, but also on the dose.” Hauser continued by saying, “incidences of major congenital malformations associated with a low dose of a higher-risk drug might be lower than that associated with a high dose of a lower-risk drug.”

Do I Have an Epilepsy Drug Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in epilepsy drug lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has given birth to a child with a birth defect that you feel may be the result of taking an epilepsy drug, you should contact us immediately. You may be entitled to compensation and / or refund by participating in an epilepsy drug lawsuit and we can help.