Anticonvulsants Causing Cleft Palate

Topamax is anticonvulsant drug. Anticonvulsants causing cleft palate and cleft lip birth defects are prescribed to women of childbearing age. Is this an ethical practice?

In March 2011, the FDA issued a press release announcing that the anticonvulsant drug Topamax had new data suggesting that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy.

A cleft lip is a birth defect where the upper lip is partially split. A cleft lip can cause the lip to be split all the way up to the nostrils on either or both sides of the lip. A cleft lip can be a standalone oral birth defect or combined with a cleft palate which does not close completely during pregnancy.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to Topamax during the first trimester of pregnancy. Infants exposed to Topamax as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.

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Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent.

Before starting Topamax, pregnant women and women of childbearing potential should discuss other treatment options with their healthcare professional. Women taking Topamax should tell their healthcare professional immediately if they are planning to or become pregnant.

Were you taking anticonvulsants while pregnant? Do you have a baby with cleft palate? If yes, please consult with Monheit Law, the Pennsylvania law firm with the answers to your concerned questions.