Topamax® Cleft Lip and Cleft Palate
The anticonvulsant medication Topamax® has been linked to the development of birth defects in infants whose mothers take the drug while pregnant. The specific types of birth defects associated with Topamax® are cleft lip and cleft palate.
What are Cleft Lip and Cleft Palate?
Cleft lip and cleft palate are among the most common birth defects. A palate is the roof of the mouth. In normal development, the lip and palate are separated at the midline until the sixth week of pregnancy, when they begin to fuse. This fusion normally occurs between the 6th and 11th week of fetal growth.
When something in the developmental process interferes with this normal fusion, a child is born with a cleft lip, a cleft palate or both.
A cleft lip can be as minor as a small notch in the upper lip or a much larger cleft that extends into the nose. A cleft in the palate can be a small deformity that causes little or no problems. Or, the cleft can be so large it interferes with eating and drinking, speaking and breathing.
Types of Clefts
There are three primary types of oral clefts:
- Cleft lip/palate is the term used when both the palate and the lip are separated. This deformity occurs in about one in 1,000 newborns. This condition constitutes about half of all clefts. It is more common in Asians and some groups of American Indians and is less common in African Americans. About 13 percent of these children also have other birth defects. This defect occurs more often in males.
- Isolated cleft palate means only the palate is cleft. This malformation happens to about one in 2,000 children. This malformation occurs in about 30 percent of all clefts and occurs with equal frequency in all racial groups. It happens more often in females.
- Isolated cleft lip refers to a malformation when only the lip is cleft. It happens in about 20 percent of all clefts.
While no one knows for sure what causes clefts, three main reasons are thought to account for them:
- A gene inherited from the mother, the father, or both. Clefts occur in families.
- Environmental factors such as the mother's poor health, such as an infection, early in her pregnancy. Toxins in the environment, including medications, drugs such as cocaine, or alcohol also cause clefts if exposure is during the first trimester of pregnancy. Some prescriptions drugs can also contribute the development of cleft lips and palates.
- A genetic syndrome, where the cleft is part of a cluster of symptoms, such as Down syndrome.
Topamax® Birth Defect Lawsuit
Topamax® is one of the environmental factors linked to oral clefts. Topamax® is a medication prescribed to reduce the frequency of seizures in epileptic patients. It also is used to prevent migraines.
On March 4, 2011, the U.S. Food and Drug Administration (FDA) issued a safety announcement, warning patients and healthcare professionals that new data showed that babies born to pregnant mothers taking Topamax® during their pregnancies were at an increased risk of having an oral cleft. The prescription labels of the medication are being updated with the new warning.
The pregnancy category for Topamax® is being changed from Category C to Category D, meaning there is evidence the drug causes birth defects in humans.
Contact a Topamax® Cleft Lip Lawyer
If your baby was born with a cleft lip or palate and you took Topamax® during your pregnancy, you should speak with an attorney about your legal right to compensation. The law offices of Aylstock, Witkin, Kreis and Overholtz boast some of the most experienced Pensacola, Florida defective drug attorneys. We are committed to helping patients get the compensation they deserve.
To schedule an evaluation of your case, contact AWKO law today at (888) 255-AWKO (2956).