Topamax® (Topiramate)

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Topamax® Cleft Palate

If your baby is born with cleft palate and you took Topamax® while you were pregnant, we may be able you seek financial compensation. Please contact us to schedule a free evaluation of your case.

What is Cleft Palate?

In the process of fetal development, the palate or roof of the mouth is cleft, or split into two sides. That is, before it is fused together at the midline, the palate is divided into a left and right side. This fusion is a normal part of the development of the fetus, along with the fusion of the left and right side of the lips. This merging in the normal fetus occurs between the 6th and 11th weeks of pregnancy.

But, under certain conditions, the left and right side of the palate fail to fuse and the baby is born with a cleft palate or a split in the structure of the mouth. These conditions can be genetic, that is the mother or father or both carry a gene for cleft palate, or they can be caused by the pregnant mother being exposed to certain toxins in the environment early in the first trimester of her pregnancy.

These toxins can include:

Certain drugs, including Topamax®, an antiepileptic medication, and other medications
Illegal drugs, such as cocaine
Radiation
Smoking
Drinking alcohol
Infection

Cleft lip/palate occurs in over 400 syndromes, meaning the occurrence of a cluster of symptoms such as Down syndrome. And about 30 percent of cleft malformations are a part of a syndrome. Therefore, if a child is born with a cleft deformity, he or she should be carefully examined to exclude the occurrence of a syndrome. Genetic counseling is also recommended for these patients and their parents.

Clefts in the palate can range from being small and having little impact on the child, to a large separation that can cause problems with eating, speaking and breathing.

Cleft palate and lips often occur together. Approximately one baby out of 1,000 is born with a cleft lip/palate. Cleft palate alone (without involvement of the lip), called isolated cleft palate, occurs once in about every 2,000 babies.

Topamax® and Cleft Palate FDA Warning

The U.S. Food and Drug Administration (FDA) released a safety announcement March 4, 2011, warning of a risk of cleft lip and palate occurring in babies born to mothers who take the antiepileptic medication Topamax® during the first trimester of their pregnancies.

The federal agency made the announcement after receiving new human data from the North American Antiepileptic Drug Pregnancy Registry.

The new data showed that:

1.4 percent of infants exposed to Topamax® were born with oral clefts
0.38 to 0.55 percent of infants exposed to other antiepileptic drugs were born with oral clefts
0.07 percent of infants born to mothers without epilepsy and not taking antiepileptic drugs had oral clefts

As a result of these new data, the label of Topamax® will have a stronger warning and its pregnancy category will be changed from Pregnancy Category C to Pregnancy Category D. This change in category means there is concrete evidence of risk to the fetus in humans (as opposed to risk in laboratory animals).