What is Topiramate?
Topiramate—the generic version of the migraine and antiepilepsy drug Topamax—went on sale in the U.S. beginning in March 2009. Many women who were prescribed Topamax by their doctors to treat migraines, seizures or other conditions may have taken generic Topiramate instead.
The Food and Drug Administration has warned that women who used Topiramate during pregnancy are more likely to give birth to children with a cleft lip or cleft palate. According to a warning issued in March 2011, children whose mothers took Topamax or Topiramate while pregnant are 21-times more likely to suffer from oral cleft defects than the children of non-users.
Based on this data, the FDA upgraded Topamax and Topiramate to its Pregnancy Category D, meaning that they have a proven risk of causing birth defects. So far, the FDA has not announced plans to issue a Topamax or Topiramate recall based on this risk of side effects.
Topiramate may also increase the risk of other serious birth defects, including craniofacial defects, persistent pulmonary hypertension of the newborn (PPHN), genital malformations, spina bifida, limb malformations, hypospadias, neural tube defects or other heart and lung defects.
If you or a loved one took Topamax or generic Topiramate during pregnancy and gave birth to a child with cleft lip, cleft palate or other birth defects, contact the lawyers at Hissey Kientz to learn more about your legal rights. You can reach us by calling our toll-free hotline at 1-866-275-4454, or by filling out the free case evaluation form on the right of this page.