March 21, 2011FDA warns of birth defects risk among women who use Topamax while pregnant

The Food and Drug Administration has issued a birth defects warning for the migraine and epilepsy drug Topamax, which is sold generically as topiramate. The agency said it was issuing the new warning after a review of birth defects data found that women taking Topamax were more likely to give birth to a child with oral cleft defects.

According to data from the North American Antiepileptic Drug Pregnancy Registry, women who use Topamax were 21-times more likely to give birth to a child with a cleft lip or cleft palate. Topamax users were also three times as likely to give birth to a baby with oral cleft defects as users of other antiepileptic drugs.

Children born to women who use Topamax during pregnancy may also give birth to children with other birth defects, including spina bifida, limb malformations, hypospadias or other genital malformations, craniofacial defects, persistent pulmonary hypertension of the newborn (PPHN) or other heart and lung defects, neural tube defects or other conditions. 

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