Drug Dilemma

Anti epilepsy drugs if taken during pregnancy may raise the risk of birth defects:

A widely used anti epilepsy drug called topiramate raises the risk of birth defects as much as 14-fold when taken by pregnant women, especially in combination with another drug called valproate, say researchers.

However, the study involved only 203 women and thus there was still significant statistical uncertainty about it, they caution.

But the results are not surprising, they added, because the drug — sold by Johnson & Johnson under the brand name Topamax — has been shown to cause similar defects in animals. Other epilepsy drugs that have been studied have also been found to increase the risk of such defects, suggesting that the entire class of drugs may interfere with the reproductive process.

Despite the enormous risks, doctors say that epileptic women cannot stop taking the drugs during pregnancy because the seizures can also damage the unborn infant, perhaps even more severely.

But women who are taking the drug to prevent migraines should halt its use if they become pregnant or are planning to do so, said Dr John Craig of the Royal Group of Hospitals in Belfast, Northern Ireland, who led the research, published recently in Neurology.

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Epilepsy is a disorder characterised by powerful seizures. Topamax accounts for about one in every five prescriptions for treating it.

Valproate, which is one of the most common drugs used in treating the problem, has previously been associated with birth defects or foetal death in about 20 per cent of women who take it.

Craig and his colleagues studied 203 women who became pregnant while taking topiramate either alone or in combination with other epilepsy drugs. Of the 203 pregnancies, 18 ended in spontaneous abortions, two in still births and five in induced abortions.

Of those born, 16 had major birth defects. Three of those were in mothers who had taken only topiramate and 13 in those who had taken it in combination with other drugs.

Four of the babies had cleft palates or lips, a rate 11 times higher than the normal rate of one in 500 expected among women not taking epilepsy drugs. Four male babies had genital birth defects, which is 14 times higher than the normal rate of one in 300.

The women in the study were part of the UK Epilepsy and Pregnancy Register, which was set up to determine the relative safety of such drugs.

Sources: Los Angles Times

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