Topiramate during early pregnancy increases risk of oral clefts

A new study published in the journal Neurology suggests that women using topiramate during early pregnancy, particularly at the high doses used to treat epilepsy, substantially increase their children’s risk of developing oral clefts.

WebMD Pregnancy

Oral clefts

Oral clefts are a group of conditions that includes cleft lip (CL), cleft palate (CP), and both together (CLP). A cleft lip contains an opening in the upper lip that may extend into the nose, whereas a cleft palate is when the roof of the mouth contains an opening into the nose. These birth defects result from tissues of the face not joining properly during development.

Oral cleft palate can often be diagnosed during pregnancy with an ultrasound exam, and can be successfully treated with surgery (usually performed before eighteen months).

Known risk factors include smoking during pregnancy, diabetes, obesity, an older mother, and certain medications.


Topiramate (brand name Topamax) was originally used as an anti-convulsant drug, but is now commonly used to treat epilepsy in children and adults. Topiramate has also been increasingly prescribed over the last decade to treat bipolar disorder and migraine headaches.

In late 2012, topiramate was approved by the United States Food and Drug Administration (FDA) in combination with phentermine for weight loss (the drug had previously been used off-label for this purpose).

Topiramate has been used for many years as the initial monotherapy in China for patients with newly diagnosed epilepsy.

New research

The study, entitled “Topiramate use early in pregnancy and the risk of oral clefts,” was authored by researchers from Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health.

Past studies have found that women taking topiramate during early pregnancy to prevent epileptic seizures had a two- to five-fold greater chance of giving birth to a baby with an oral cleft, but such studies did not focus on women taking the drug at a lower dose for non-seizure related conditions. The new study suggests that using topiramate in early pregnancy, particularly at the high doses used for epilepsy, substantially increases the risk of oral clefts.

Specifically, while approximately one out of every 1,000 infants are born with an oral cleft palate, among infants exposed to low doses of topiramate (defined as 100 mg each day) in the first trimester that risk was 2.1 out of every 1,000 live births, while among women taking higher doses of topiramate (defined as 200 mg each day), e.g., for the treatment of epilepsy, the risk was substantially higher at 12.3 for every 1,000 live births.

Accordingly, the best course of action for women of childbearing age may be to avoid prescribing high doses of topiramate to unless the benefits clearly outweigh the risks.

5 Responses to “Topiramate during early pregnancy increases risk of oral clefts”

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