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Topamax seems on its way to being classified as a Pregnancy Category D due to the FDA's findings. Pregnancy Category D medications are named as such when positive indications exist that their usage presents human fetal risk. The effectiveness of the medication on such a severe disorder - epilepsy - and the rarity of the defects being reported have prevented manufacturers from pulling topiramate altogether. There are many considerations to be made regarding the usage of the medication, none more paramount than weighing the benefits of the drug therapy against the potential for a cleft palette.

Oral clefts - according to the North American Antiepileptic Drug Pregnancy Registry - are occurring in a prevalence of 1.4 percent of children of parents on topiramate with no other antiepileptic drugs in their prescription regimen. Infants whose mothers were on antiepileptic medications other than topiramate are presenting with an oral cleft in .38 to .55 percent of all births. The difference between those solely on topiramate - versus mothers birthing while under a combination of medications for epilepsy - represent conclusions that should promote extreme caution and careful monitoring.

Since Topamax is used to treat seizures in epilepsy patients, failing to take the medication can have serious side effects. The best practice for mothers of childbearing age who suffer from epilepsy may be to seek an alternative therapy for the condition. Through open and thorough discussion with the physician, usage of topiramate may be discontinued if the risk is deemed to outweigh the current benefits of the drug. If it is proven that the birth defects showing up in children of mothers on topiramate are indeed a collateral effect of the drug, class-action suits would likely follow. Although no legal action has been taken as of yet, the ruling by the FDA that the medication should be tagged with a label for increased risks hints at something concrete.

Topamax is made by pharma giant Johnson & Johnson (JNJ).