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Birth Defect Risk Seen With Topamax

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Topamax, a drug used to treat epilepsy and migraines, has been linked to birth defects, especially when used in combination with the drug valproate. Many epilepsy drugs carry an added risk for miscarriage and birth defects, but women with epilepsy often have no choice but to continue taking drugs like Topamax during pregnancy because epileptic seizures also put fetuses at risk. However, unlike many other epilepsy drugs, Topamax is taken by millions of women of child bearing age for migraines, which means much more of the population could be at risk for birth defects associated with the drug.

Since 2004, when the Food & Drug Administration (FDA) approved it for the treatment of migraines, Topamax has become one of the most widely prescribed drugs for the condition, which affects almost 30 million Americans. Women are three times more likely to suffer from migraines than men; women in their childbearing years are particularly vulnerable

The study, published in the journal “Neurology”, which was conducted by British researchers at the Royal Group of Hospitals in Belfast, Northern Ireland. It involved 203 women who were taking Topamax either alone or in combination with another epilepsy drug when they became pregnant. Of 178 live births that occurred, three babies whose mothers took Topamax alone and 13 whose mothers took Topamax along with other anti-epilepsy drugs had major birth defects.

Four of the babies had cleft palates or cleft lips, which was 11 times higher than would be expected among women not taking epilepsy medication. Four male babies had genital birth defects, with two of these classified as major birth defects. Minor defects included a hole above the buttocks, a flattened head, toe webbing, clicky hips and immature hip joints. The birth weights weren’t significantly lower than in the normal population.

All epilepsy drugs are known to increase the risk of miscarriage and birth defects, and researchers conducting this study said the Topamax risk was similar to that seen with similar medications. However, more birth defects occurred in women taking Topamax along with the drug valproate, or valproic acid, than in women taking other epilepsy drugs or other Topamax drug combinations. Valproate is sold as Depakote by Abbott Laboratories and as Depakine by Sanofi- Aventis. Previous research has shown that valproate is associated with an increased risk of birth defects such as heart defects and spina bifida.

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