Topamax Birth Defects

The risk for oral birth defects in children born to women dramatically rises when treated with Topamax during pregnancy, a warning announced  by the Food and Drug Administration (FDA) last March 2011.   Topamax, topiramate in its generic version, is an anticonvulsant drug approved by FDA that is prescribed to treat certain types of seizures in epilepsy patients.   In addition, this drug has also been accepted to prevent migraine headaches. 

This anti-seizure drug was previously classified as a Pregnancy Category C drug which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval.    Apparently new human records show an increased risk for oral clefts placing Topiramate in Pregnancy Category D.  This category means there is positive evidence of human fetal risk based on human data.   But there are some instances where the benefits outweigh the risks to the mother.   Ordering drug to the pregnant patients can only be done after precise deliberationData from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate monotherapy during the first trimester of pregnancy.The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% - 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs.  The risk of oral cleft in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was significantly higher compared to the risk in a background population of untreated women.

Similar reports from the UK Epilepsy and Pregnancy Register show increased prevalence of oral clefts (3.2 %) among infants exposed to topiramate monotherapy, a 16-fold increase in risk compared to the risk in their background population (0.2%). 

Cleft lips and cleft palates are congenital defects in which the tissues of the mouth or upper lip don't form properly during fetal development. Both oral defects can be successfully corrected with surgery, especially so if conducted soon after birth or in early childhood. Both oral malformations can be surgically-corrected, especially when done soon after birth or in early childhood.   Treatment is important for children with cleft lip or palate. Without treatment, complications may arise from eating and talking inconveniences to emotional and behavioral difficulties.