Babies At Higher Risk For Oral Birth Defects Due To Mother's Topamax Therapy

Women taking Topamax during pregnancy are putting their children at higher risk for oral birth defects. This was publicly proclaimed by the Food and Drug Administration (FDA) on 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.  It is also approved for prevention of 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.   However, Topiramate is being placed in Pregnancy Category D after new human data showing an increased risk for oral clefts.   Evidences of human fetal risk based on human records are noted on drugs sorted in this group.  Nevertheless there are situations where the drug's benefits to the mother outweigh its risks.  Careful weighing of the benefits and risks must be done before prescribing the drug to gravid patients.  Babies when exposed to topiramate therapy during the first trimester of pregnancy have a relatively higher chance of oral clefts according to the North American Antiepileptic Drug (NAAED) Pregnancy Registry.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 numbers shown by NAAED Pregnancy Registry with regard to the risk of oral defects in infants exposed to topiramate treatment dramatically higher compared to the risk in their background population.

Relative results were from the UK Epilepsy were shown. The 3.2% incidence rate among infants subjected to topiramate monotherapy is about a 16-fold increase in risk compared to the risk in their background population at 0.2%

Cleft lips and cleft palates are two types of congenital anomaly where there is a non-fusion in the mouth that splits the upper lip or the roof of the mouth called the palate.   With surgical operation done at an early age, these oral misshapes can be fixed.  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.