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Topiramate labels are now being updated with the new information describing the increased risk of oral clefts formerly known as harelips. Cleft palate is a condition in which the two plates of the skull that form the roof of the mouth are not completely joined.
The North American Antiepileptic Drug Pregnancy Registry (NAAED) has shared data with the FDA showing an increased risk of cleft palates and cleft lips in infants exposed to Topamax during the first trimester of pregnancy. The United Kingdom's pregnancy registry had similar data.
Infants are 20 times more likely to develop cleft palate when their mothers take Topamax in pregnancy, when compared to women not receiving any anti-seizure medication (1.4% versus 0.07%).
The relative risk for development of cleft palate in infants of mothers who take Topamax in pregnancy, compared to those taking an anti-seizure medication other than Topamax during pregnancy is between 3.68 (1.4% vs. .38% and 2.55 (1.4% vs. .55%). There is a class effect, but Topamax is riskier than its anti seizure competitors.
But what are you to do as a mother if your baby was already born with a cleft palate or cleft lip?
Do you have a Topamax birth defect lawsuit?
Do not hesitate to contact the law firm of Anapol Schwartz to find out what your legal options are regarding unsafe drugs prescribed during your pregnancy.