Pregnancy Bliss | Reproductive Health Answers
Published: Tuesday, March 08, 2011 - 16:45
Topiramate is also used in some countries for the prevention (but not treatment)
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.