Analysis Finds Keppra, Lamictal May Need Tougher Birth Defect Warning

Analysis conducted by Adverse Events reveals that epilepsy medications <"">Keppra and Lamictal are more dangerous than first believed. Using U.S. Food and Drug Administration (FDA) data, Adverse Events found that Keppra and Lamictal appear to be more dangerous when taken during pregnancy that the drugs’ FDA labeling indicates, said the San Francisco Gate.

The comparison used FDA adverse event reporting data and information on popularly prescribed epilepsy drugs taken by women when pregnant, said the SF Gate. It turns out that there are inconsistencies between FDA’s drug labeling and its data.

Today, the FDA classifies medications taken during pregnancy on a risk scale from Class A (“no known risk”), through Class D, in which the drugs increase in risk, to the one final class X (“danger – do not use”). Lamictal and Keppra, both Class C, were found to be “as dangerous to a fetus as drugs currently listed” in the riskier Class D, said the SF Gate.

The analysis also revealed that, based on an “average birth defect rate comparison” between classes C and D, no meaningful differences were detected between the two drugs, pointing to a disparity, or even a bias, in how the FDA classifies pregnancy risks for epilepsy medications, said the SF Gate.

As we have long written, epilepsy drugs have been linked to a number of serious side effects. A study published in the January issue of Archives of Neurology, found that most epilepsy drugs are associated with an increased risk of nontraumatic fracture in individuals 50 years of age and older.

Earlier research also revealed an adverse effect on anti-epileptic drug treatment on bone and mineral metabolism. And, one previous study revealed anti-seizure medications had the same effect on the incidence of osteoporosis in older men as it did in older women.

Some epilepsy drugs have been associated with an increased risk of neural tube and other birth defects when taken by expectant mothers, especially in the early months of pregnancy. Some of those medications have been identified as Class D drugs.

In December 2009, the FDA ordered that a suicide warning be added to the labels of more than two dozen epilepsy medications including Keppra, Keppra XR, and Lamictal. The FDA’s action followed a review of 199 clinical trials of 11 antiepileptic drugs, which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent).

Another study—results appeared in the Journal of the American Medical Association (JAMA)—reviewed anti-seizure medication Lamictal (generic: lamotrigine) and other similar drugs. The study revealed a slightly increased risk in birth defects in expectant mothers versus other women who did not take anti-seizure medication.

As we’ve written, use of anti-seizure drugs in pregnant women is on the rise because while about one in 200 women take the medication for epilepsy, the medications are being used to treat other conditions, including migraines and bipolar disorder.

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