The U.S. Food and Drug Administration (FDA) notified patients and healthcare providers about an increased risk of certain birth defects in babies whose mothers use Topamax® early in their pregnancy on March 4, 2011. The agency said its warning is based on data from the North American Antiepileptic Drug (AED) Pregnancy Registry.

Data shows babies are at a greater risk of suffering cleft lip and cleft palate, facial and oral abnormalities, when they are exposed to Topamax® (topiramate) in the first trimester.

Healthcare Providers

The FDA asked healthcare providers to warn all female patients that are of childbearing age about the risk of birth defects. The drug's label will include information about the potential birth defect risk. Women who are or become pregnant should talk to their doctors about the possible risks and should not stop taking the medication unless told to do so by their doctor.

The FDA encourages women that become pregnant to talk to their doctors about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that gathers information about women who take antiepileptic medications during their pregnancies.

Topamax® and Cleft Lip

The specific types of birth defects linked to Topamax® are cleft lip and cleft palate. Both defects are oral and facial abnormalities that can be corrected through surgery. Oral clefts occur when the either the lip or the roof of the mouth don't fuse together during fetal development and a separation or cleft is formed. The defects can range from minor to severe.

In more severe cases, patients might experience complication such as:

• Difficulty eating
• Problems speaking properly
• Ear infections
• Dental problems

Babies can be born with cleft lip and cleft palate, or one or the other. Because oral clefts are visible, they are easily diagnosed at birth. In more severe cases, a diagnosis might be made early through a sonogram.

Treatment for Topamax® Birth Defects

When a baby is born with a cleft lip and/or cleft palate, he or she will likely need surgery to correct the abnormality. In some cases, multiple surgeries may be necessary. Infants with cleft lip and palate will usually achieve a normal appearance and be able to speak properly, although for some patients, the process can take years.

Even though oral clefts are not life-threatening, they can severely impact a person's life. Children may need therapy to get through the emotional hardships associated with having a physical deformity and the emotional stress can take its toll on the parents as well. Medical bills and the cost associated with speech therapy and other necessary treatments can add up quickly.

If your child is born with a cleft lip or palate, and you took Topamax® during your pregnancy, you should speak with a Topamax® birth defect lawyer at AWKO Law. Call 1-888-255-2956 to schedule an evaluation of your case.