According to the Food & Drug Administration (FDA), “…there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate during pregnancy.” Topiramate is sold as “Topamax” by Johnson & Johnson, as well as generically. Topamax is an anticonvulsant medication used to treat patients with epilepsy who have certain types of seizures, and is sometimes used to treat migraine headache sufferers.

These birth defects include:

  • Cleft lip and/or cleft palate.
  • Genital birth defects
  • Possible increased risk of spinal deformities, limb malformations, cranial defects, and other congenital birth defects.

The brain disorder epilepsy and the resulting seizures can be debilitating and potentially dangerous for sufferers. Advances in medication and treatments for epilepsy are noble causes. However, potential side effects and unwanted risks should be disclosed before anyone is prescribed medication.

Topiramate is an anticonvulsant medication, and many other anticonvulsants used to treat epilepsy are known to cause birth defects. The FDA previously classified Topamax as a Pregnancy Category C drug, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. The FDA now says that, “Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data.”

Oral clefts can cause feeding problems for infants and children, as well as inhibiting speech. Clefts can lead to ear infections that may produce hearing loss. Often lip and palate clefts cause children to have problems socializing with other children and lead to psychological problems. Other birth defects potentially caused by Topamax can be extremely debilitating and/or shorten the life expectancy of children dramatically.

Topamax/topiramate was prescribed to more than 4 million patients, and prescriptions were filled more than 32 million times from 2007 through 2010 in the United States.