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Published: Tuesday, March 08, 2011 - 16:45


Topiramate (also available in brand names Topamax or Topiragen), one of the common anti-epileptic drugs that is sometimes taken during pregnancy has been confirmed to increase the likelihood of babies being born with cleft lip and cleft palate, according to new data, the Food and Drug Administration (FDA) in the United States has written in a communiqué.

The FDA says that doctors should warn their female patients of childbearing age about the possible dangers to the fetus if they become pregnant while taking Topiramate.

Topiramate is currently used for the treatment of epilepsy in adult as well as children. In children, it is used to treat Lennox-Gastaut syndrome, a disorder which tends to appear early in childhood and is characterised by seizures, behavioural problems and often learning difficulties.

Topiramate is also used in some countries for the prevention (but not treatment) of migraine.


Cleft lip and palate are types of congenital abnormalities. They result from abnormal developments of the face while the fetus is in the womb. In some cases, babies are born with both - cleft lip and palate even though the commonest presentation is that of a cleft lip with an intact palate. Before the baby is born, natural structures form in the body and fuse. A cleft is when these structures do not fuse leaving a gap. When the gap occurs in the upper lip it is a cleft lip, in the roof of the mouth (palate) it is called a cleft palate. Occasionally both sides of the lip are affected producing a bilateral cleft. This abnormal development takes place quite early during pregnancy and is complete by the end of the first trimester. This is therefore the critical period during which the taking of Topiramate could have this effect.

According to the North American Antiepileptic Drug Pregnancy Registry, there is a raised risk of cleft lip and/or palate in infants whose mothers took topiramate during the first three months of their pregnancy.


Twenty-fold increase in risk

The risk of being born with a cleft lip and/or palate is:

1.4% among infants exposed to topiramate as a single therapy during their mother's pregnancy

0.38% to 0.55% for infants whose mothers took other antiepileptic drugs during their first trimester

0.07% for infants whose mothers did not have epilepsy and took no antiepileptic drugs

These statistics therefore suggest that expectant mothers who take Topiramate during the first trimester increase their risk of having a baby with a cleft palate or lip 20-fold compared to the average (non-epileptic and not on anticonvulsant medication)

According to the FDA, data from the UK Epilepsy and Pregnancy Register were similar.



Pregnant mothers and females of childbearing age who are considering taking Topiramate should talk to their doctors about alternative treatments particularly so if they are planning to conceive or if there is a chance of pregnancy, even if unplanned. Because many pregnancies are confirmed relatively late in the first trimester, advice once pregnant is of limited effectiveness.


Never stop medication suddenly


What is stressed in particular is that any woman on anti-epileptic medication including Topiramate should not stop taking the medication without informing her doctor. That is even if she finds herself pregnant. A sudden cessation of taking Topiramate often leads to increased seizure activity, something that can be dangerous and even life-threatening.

Cleft lip and palate are usually successfully repaired surgically in early childhood
(picture above shows a cleft palate and lip and [right], a year after repair).



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Topiramate use in pregnancy and risk of cleft lip and palate








By Dr Joe Kabyemela, MD