Epilepsy drug during pregnancy raise oral birth defects, says FDA

Consuming an epilepsy drug -also effective in preventing migraine- during pregnancy may put the baby on higher risk for cleft lips and cleft palates, say FDA reports.

Recent Food and Drug Administration (FDA) figures confirms that women taking Topamax, during pregnancy, raise the chances of oral birth defects in their babies.

FDA officials asked physicians to caution their women patients, taking the drug, about possible risks.

Risk occurs at the initial stage of pregnancy
The infant is exposed to the risks during the initial three months after conceiving, the stage where a woman might not be aware of her pregnancy, alarm FDA officials.

Head of FDA Division of Neurology Products, Russell Katz maintains doctors should examine a female patient’s case carefully, who is at her childbearing age, before recommending the drug and "alternative medications that have a lower risk of birth defects should be considered.” said Katz.

Cleft lips and cleft palates cause a split lip or a hole on the baby’s mouth roof. It develops at the primary stage when the mouth is not fully formed inside the mother’s womb.

The condition deprives the baby of adequate nutrition and can also result in several issues related with the growth and nutrition. However, the cleft can be set right with a surgery; at times it requires multiple operations too.

Topamax and topiramate, both increase the risk
Meanwhile, Topamax maker Jonson and Jonson’s clarified the drug’s tag beforehand cautions about its usage during pregnancy. The drug tag says "recommended cautious use in pregnant patients”.

However, it will collaborate with FDA on its usage amongst pregnant women, said the company.

Last year, J&J made $569 million from Topamax sales worldwide, in contrast to $2.7 billion earlier in 2008, before the competitors like Teva , Watson, Mylan Inc and other generic “topiramate” makers entered the market.

The FDA report on oral-birth-defect risk is prepared on the basis of data collected from North American Antiepileptic Drug Pregnancy Registry.

The data confirmed that 1.4 percent of the babies, with cleft lips and palates, were exposed to Topamax or rivals’ topiramate, against 0.38 percent to 0.55 percent babies whose mothers were consuming other drugs for epilepsy.

At the same time, only 0.07 percent babies had this defect whose mothers were not on any such drugs during pregnancy, revealed data.