Topamax® (Topiramate)

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Topamax® Oral Cleft Lawsuit

Our defective drug lawyers are available to investigate Topamax® cleft lip lawsuits on behalf of parents and infants affected by this birth defect. If you took the seizure medication during the first trimester of your pregnancy and your child was born with cleft lip or palate, contact us for a free case review.

What Is Oral Cleft?

An oral cleft is a birth defect. All human fetuses begin life with an oral cleft, that is, a cleft lip and cleft palate. But, during the development of the fetus, as its mouth, nose and palate grow to become more and more like those of a normal human baby, these clefts, or separations, fuse. Between the 6th and 11th week of development, the fetus’ face joins together at its center. Until then, the lips and palate (roof of the mouth) are separated into right and left sides.

The three main types of oral clefts are:

Cleft lip/palate, when both the lips and palate are cleft. This type of cleft, the most common type of oral cleft, occurs in about 1 in 1,000 births. It occurs more often in males. It makes up about 50 percent of all clefts. It happens more frequently in Asians and some American Indians and less frequently in African Americans. As many as 13 percent of these children have other birth defects.
Isolated cleft palate means that only the palate is cleft. The palate is the roof of the mouth, the hard palate being at the front of the mouth and the soft palate being at the back. This type of defect occurs about once in 2,000 births, and constitutes about 30 percent of all clefts. The risk is the same for all racial groups and it occurs primarily in females.
Isolated cleft lip is the term used when only the lip is cleft. About 20 percent of all clefts are isolated cleft lips.

Causes of Oral Clefts

It is not certain what the cause is for oral clefts. But three main factors are considered important in the occurrence of this malformation.

Genetic trait, when one or both parents were born with a cleft. Clefts tend to run in families.
Environmental causes. This might be poor health of the mother in early pregnancy, such as an infection. Exposure to environmental toxins are thought to be another cause of oral clefts. Such toxins would include alcohol, smoking, cocaine, and medications such as Topamax®.
Oral clefts occurring as part of a syndrome or genetic deformities that have a cluster of characteristics, such as Down syndrome. Since about 30 percent of oral clefts are associated with a genetic deformity, it is important for the physician to thoroughly examine the baby for the possibility of the occurrence of a syndrome.

Topamax® and Oral Clefts

Topamax® (topiramate) was recently declared to increase the risk of infants being born with cleft lip and/or cleft palate if their mothers took the medication early in their pregnancies. The announcement was made by the U.S. Food and Drug Administration (FDA), which based its warning on scientific data.

The FDA issued a safety communication March 4, 2011, to healthcare providers and the public about recent clinical findings that Topamax® increased the risks of babies being born with oral clefts.

As a result of the new research, the FDA changed the pregnancy category of topiramate from Category C to Category D. The D indicates the drug has been found to cause birth defects in humans.