Topamax® Birth Defects

FDA Alert: Topamax® May Cause Birth Defects

New research indicates the antiepileptic medication Topamax® can cause cleft lip and palate (roof of the mouth) in babies born to mothers taking the drug in the 6th through 11th weeks of their pregnancies. The U.S. Food and Drug Administration (FDA) published the new information March 4, 2011.

The federal agency based its announcement on data gathered by the North American Antiepileptic Drug Pregnancy Registry. The data indicate that:

  • 1.4 percent of babies of mothers who took Topamax® during their first trimester of pregnancy were born with oral clefts (cleft lip and cleft palate)
  • 0.07 percent of babies of mothers who were not epileptic and did not take any antiepileptic medication were born with oral clefts
  • 0.38 to 0.55 percent of babies of mothers who took other antiepileptic drugs were born with oral clefts

The data were supported by similar results obtained by the United Kingdom Epilepsy and Pregnancy Register.

Because of the new findings, Topamax® and topiramate generic versions of the drug will carry stronger warnings on its labels. The patient medication guide and prescribing information will also include the updated information.

Topamax® Pregnancy Category D

In addition, the pregnancy category of the drug will be changed from Pregnancy Category C to Pregnancy Category D. The latter indicates the drug has been shown to cause birth defects in humans (as opposed to data collected on animals during research).

Types of Birth Defects Linked to Topamax®

Infant clefts of the lip and palate, together called oral clefts, have been linked to their mothers taking Topamax® early in the first trimester of their pregnancies.

The lips and palates of fetuses are normally cleft or separated when first formed, but come together between the 6th and 11th week of their development. However, in some infants of mothers taking Topamax®, these parts don't join and the newborn is born with a cleft lip, cleft palate, or both.

A small cleft can be just a tiny notch in the upper lip. But this can extend into the nose. A cleft palate can be a small deformity that causes few problems to a large split in the palate that can result in problems with:

  • Eating
  • Speaking
  • Breathing

There are three main kinds of clefts:

  • Cleft lip/palate when both the lip and palate are separated
  • Isolated cleft palate refers to a cleft in the palate alone
  • Isolated cleft lip refers to a cleft in the lip alone

Women who become pregnant while they are taking Topamax® should contact their doctors immediately. Their physicians may want to change their antiepileptic medication. Women should not stop taking the drug without speaking with their doctors, however.

If your child is born with cleft lip or palate and you were treated with Topamax® during your pregnancy, contact AWKO law today at (888) 255-AWKO (2956). Our dangerous drug lawyers can help you seek compensation for your suffering.