Birth Defect Risk for Topamax®

Topamax® is a brand name anti-seizure medication used to treat epilepsy, and is also sometimes used to treat migraine headaches. In generic form it is called topiramate. While it is an effective medication, there are risks involved when taken by women who are pregnant or could become pregnant.

Recent alerts, issued by the U.S. Food and Drug Administration (FDA), warn of an increased risk of serious birth defects in babies whose mothers take Topamax® during the early months of pregnancy.

Topamax® Case Study

According to data from the North American Antiepileptic Drug (AED) Pregnancy Registry, infants exposed to topiramate experienced a 1.4 percent chance of cleft lip or cleft palate. Infants exposed to other antiepileptic drugs experienced a 0.38–0.55 percent chance of oral clefts.

Seizures caused by epilepsy are also dangerous to a fetus. The FDA says in some cases, the benefits of the drug will actually outweigh the risk of birth defects. Patients that become pregnant while taking Topamax® should speak with their doctor before deciding to stop taking the medication on their own. The agency has asked healthcare providers to explain the potential risks to all female patients that are of childbearing age.

FDA Updates Topamax® Warning Label

After receiving this information, the FDA decided to update the warning label on the medication to reflect a stronger birth defect warning. The pregnancy category has also been changed from C to D, meaning there is evidence of birth defects in humans.

Cleft Lip and Palate Risk

Clefts are caused when structures of the face fail to fuse together during development, leaving gaps. A cleft lip can range in severity from a small notch in the upper lip, all the way to a gap running through the lip up into the nose and gums. A cleft palate can include both the soft palate (the back of the mouth) and the hard palate (near the front of the mouth).

Both a cleft lip and a cleft palate can usually be fixed through surgery, but there are risks that the child will have trouble feeding, develop speech problems and experience hearing loss.

Treatments can extend over the course of the patient’s life. Treatments might include:

  • Surgery to repair the cleft
  • Plastic surgery to fix the physical appearance
  • Speech therapy to help with pronunciation
  • Dental work
  • Hearing aids to help with hearing loss

Treatment might also include seeing a physiologist to help with the emotional stress cause by the defect.

Get Legal Help for Birth Defects

If your baby is born with a birth defect, it can be extremely emotional. A lawyer can help you seek justice from the makers of the drug. To schedule a free consultation with a Topamax® birth defect lawyer, please contact us today.