A non-profit group believes two epilepsy drugs should be reclassified by federal regulators to indicate their risk of birth defects if they’re taken by pregnant women.
According to a statement from AdverseEvents Inc., the epilepsy drugs Keppra and Lamictal should be classified as Category D because they have evidence pregnant women taking them can injure their fetus. These drugs are currently classified by the Food and Drug Administration as Class C, meaning they pose no known risk of adverse events.
The FDA provides a classification system which prescribing physicians rely on almost exclusively for determining the safety of prescription drugs for pregnant women. They are classified either B, C, D, or X. Category X drugs are those which should be avoided entirely.
Based on its study of records from Jan. 1, 2004, through March 31, 2011, held by the FDA Adverse Events Reporting Systems (AERS), AdverseEvents Inc. believes the drugs Keppra and Lamictal pose as great a risk to the fetus as drugs currently in Category D. Further, it found the top drugs listed in Category C carried a similar risk of birth defects when taken by epileptic women expecting a baby as drugs in Category D.
The study found that Keppra and Lamictal carry serious risks of birth defects and stillbirths among pregnant women taking these anti-seizure medications. Most troubling is that epileptic women typically aren’t afforded the option of stopping their anti-seizure medications due to the complications that could cause themselves and the child they’re carrying through a full pregnancy.
The release indicates: “Analysis using the RxFilter process, however, indicated that certain category C class drugs may actually be as dangerous to a fetus as drugs currently listed in category D. These results indicate that regulatory bodies may want to consider category shifts for some of the most widely used antiepilepsy medications.”
AdverseEvents Inc. urges the FDA to examine its data and compare it to the data it uses to categorize the drugs it has listed in its Category C.
The concerns raised by this study echo those found at the conclusion of other recent safety studies on the impact of epilepsy drugs to pregnant women and is the latest to indicate these drugs like Keppra may result in birth defects to fetuses.
One study found that pregnant women taking anti-seizure medications through their pregnancy faced a six percent risk of having a child born with at least one birth defect. The normal rate of birth defects among women not taking the drugs is two-tenths percent. Taking more than one anti-seizure medication increases the risk of birth defects to close to seven percent.