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Drug Effects or Epilepsy Effects?

A new study finds that more babies of women with epilepsy taking antiepileptic drugs during pregnancy had malformations than did babies born to women without epilepsy or to women with epilepsy who were not taking medication during pregnancy.

A study by Lewis Holmes, M.D. and his colleagues, writing in the April 11 issue of the New England Journal of Medicine, found that effects of medications during pregnancy (based on results in two groups of pregnant women with epilepsy and one group of pregnant women without epilepsy) reported an increased rate of malformations.

The study was designed to see whether use of antiepileptic drugs or the fact of having epilepsy was responsible for higher malformation rates.

In this study, more babies of women with epilepsy taking antiepileptic drugs during pregnancy had malformations than did babies born to women without epilepsy or to women with epilepsy who were not taking medication during pregnancy.

Holmes concluded that, since the children of the women with epilepsy who were not on medication did not have a higher malformation rate, it was therefore the drugs, not the epilepsy, that were responsible for the higher rates in the medication group.

Others were not so sure, noting that the group of women with epilepsy who were able to live free of medication might have a different experience of epilepsy and therefore might not be directly comparable to the women who needed medication.

All the drugs studied in the New England Journal of Medicine report - phenytoin, phenobarbital, carbamazepine, valproic acid and combinations of these - were associated with one or more types of defect.

Major birth defects were found in 4 percent of the 223 babies whose mothers had taken one of the drugs during pregnancy and 8.6 percent of the 93 whose mothers took two or more.

None of the 98 babies whose mothers with epilepsy not on medication had defects; 1.8 percent of the comparison group of 508 babies whose mothers did not have epilepsy or take medication had major defects.

Newer medications were not included in the study.

The results of these studies do not change current advice to women with epilepsy who are already pregnant (don't suddenly stop the medication, check with your doctor) or who are considering becoming pregnant (check with your doctor about your therapy before becoming pregnant, and be sure to ask about folic acid supplementation).

Despite the rates of malformation (primarily cleft lip/cleft palate and heart abnormalities) reported in the studies, more than 90 percent of women with epilepsy who become pregnant deliver healthy babies.

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