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05 February 2018

Risk of oral clefts increased for babies exposed to topiramate

Latest research from the US has shown that babies born to women with epilepsy who are taking the medication topiramate during the first trimester of pregnancy, are at a higher risk of being born with a cleft lip or palate.

The study of 1,360,101 pregnancies compared women taking topiramate with those not taking the drug. Researchers also looked at women who were prescribed lamotrigine.

Topiramate is prescribed for epilepsy but also for other conditions including bipolar disorder. The number of babies born to women taking topiramate was 2,425.

Results of the study

Results of the study, published in Neurology showed that the risk of oral clefts at birth was 4.1 per 1,000 in the infants born to women exposed to topiramate compared with 1.1 per 1,000 in the unexposed group. In the lamotrigine group, the risk was 1.5 per 1,000 births.

However the risk was found to be higher when looking specifically at women prescribed topiramate for epilepsy. In this group there was a risk of oral clefts at birth of 12.3 per 1,000.

The higher risk was thought to be associated with the higher dosage of topiramate prescribed to women with epilepsy.

Pre-pregnancy review

Epilepsy Society's medical director, Professor Ley Sander,  said that the research  provided useful data which should be considered when prescribing to women of childbearing age. However, he stressed that the study involved a relatively small number of women with epilepsy.

"It is important that all women seek a review of their medication prior to trying for a family," said Professor Sander. "Good seizure control is vital during pregnancy, for the health of both the baby and the mother. It is a priority to make sure that the woman is on the most appropriate treatment to ensure the best outcomes for her baby at birth."

If you have any concerns about your medication, always consult your doctor. You should never stop taking your medication  unless under the supervision of your neurologist.

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