Topamax® is the brand name for topiramate, a medication used to treat epilepsy. The U.S. Food and Drug Administration (FDA) issued a warning on March 4, to alert healthcare providers and patients that all medications containing topiramate carry risks to babies whose mothers take it while pregnant.

Generic Form of Topamax®

Topiramate is an anti-seizure medication that works by slowing down abnormal electrical signals that cause epileptic seizures. The medication also helps calm excited nerve cells in the brain that may cause migraine headaches. Clinical studies have shown that 75 percent of topiramate users who followed the correct dosage instructions were seizure free for one year.

Topiramate is an effective medication when used properly. There are some potential dangers that should be carefully considered by healthcare providers when prescribing Topamax®, however.

Minor side effects of Topiramate include the following:

  • Burning or tingling sensations
  • Dizziness
  • Fatigue and drowsiness
  • Loss of appetite, weight loss
  • Nausea
  • Diarrhea
  • Insomnia
  • Impotence

Topiramate and Birth Defects

Data suggests that topiramate significantly increases a baby’s risk of developing oral clefts if he/she is exposed during the first several weeks of fetal development. According to data, topiramate increases the risk of oral clefts more than any other anti-seizure drug. Cleft lip and cleft palate occur when the structure of the lip or palate fail to fuse properly. This occurs during the first several weeks of pregnancy.

Cleft lip and palate are among the most common birth defects in the U.S. They can be treated with surgery and in most cases patients will achieve normal eating, speaking and physical appearance. In severe cases, patients will have difficulty with speech, hearing and eating.

If you were taking a topiramate-based drug such as Topamax® while you were pregnant and gave birth to a baby with cleft lip or palate, we may be able to help you recover compensation for your medical costs, long term treatment and pain and suffering.

To schedule a free case review, contact a Topamax® lawyer today.