Biotech Values

[jellybean]

July 23, 2008 — Preliminary results from a new study suggest taking the antiepileptic drug (AED) topiramate (Topamax, Ortho-McNeil Neurologics) during pregnancy, either alone or in combination with other AEDs, has been linked to an increased risk for congenital malformations.

Investigators found that topiramate, also used to prevent migraine, was linked to an overall rate of cleft lips or cleft palates that was 11 times higher than that of the general population. Of 78 live male births, hypospadias occurred in 4 of these infants, 2 of which were considered major congenital malformations (MCMs). This rate is 14 times higher than that seen in the general population.

However, the investigators and other experts say the findings should be interpreted with caution, owing to the small number of study subjects and wide confidence intervals.

"More research needs to be done to confirm these results, especially since it was a small study. But these results should get the attention of women with migraine and their doctors, since topiramate is also used for preventing migraine, which is an even more common condition that frequently occurs in women of childbearing age," principal investigator John Craig, MRCP, from the Royal Group of Hospitals, in Belfast, Northern Ireland, said in a statement from the American Academy of Neurology.

The study is published in the July 22 issue of Neurology.