Recently, the Food and Drug Administration (FDA) announced new data that suggests that Topamax, a drug used to treat epilepsy and prevent migraine headaches, and its generic forms leads to an increased risk of an infant born with cleft palate and cleft lip if their mother took the medication during the first trimester of pregnancy.
What Is Cleft Palate?
Cleft palate is a type of birth defect in which the two plates of a person's skull that form the hard palate (the roof of their mouth) are not joined completely. In these instances, the soft palate is also affected. Cleft palate can occur in two versions: complete, in which the soft and hard palates are affected and may also include a gap in a person's jaw; or incomplete, in which there is typically a hole in the roof of a person's mouth and the soft palate is mainly affected. In both versions, the uvula is typically split. A cleft palate can occur on one or both sides of a person's mouth, and often goes the full length of the palate. The plates that fail to fuse in cases of cleft palate are supposed to fuse within the first trimester of pregnancy, which is why the risks for Topamax birth defects are at their peak during that time.
In most cases of cleft palate, cleft lip is also present, which can also apply to infants exposed to Topamax during the first trimester. When a cleft does not affect the palate structure of a person's mouth, it is generally referred to as cleft lip. Cleft lip can be a small notch on a person's lip, which is referred to as a partial or incomplete cleft, or may be a complete split in the lip that goes all the way to the base of their nose, which is called a complete cleft. There are two versions of cleft lip: unilateral, when it is one sided, or bilateral, when it is two sided. Cleft lip is caused by the failure of the maxillary and medial nasal processes to fuse.
Oral Cleft Birth Defects
Collectively, cleft palate and cleft lip are commonly referred to as oral clefts. Oftentimes these birth defects can cause a person to have misaligned teeth and may also change their nose shape. When a baby is born with one or both of these defects, other problems that may result due to cleft palate or cleft lip are:
- Difficulty eating
- Failure to gain weight properly
- Poor growth
- Recurrent ear infections
- Speech problems
- The flowing of liquids through the nasal passages when eating
Cleft Palate Surgery, Treatment, and Recovery
Typically cleft palate repair is done when a baby is older, usually between 9 and 12 months, to allow the palate to change as they grow. When the repair is done at this age, it will help prevent additional speech problems as the baby develops. For cleft palate repair surgery, an infant will be given general anesthesia. Often, tissue from the roof of an infant's mouth will be moved to cover up their soft palate. To completely close their palate, oftentimes an infant will require more than one operation. Depending on the severity of the Topamax cleft palate defect, a surgeon may also need to repair the tip of an infant's nose in what is called rhinoplasty.
As with any surgery that uses anesthesia, there are risks, which include adverse reaction to medications, breathing problems, bleeding, and infection. Specifically, cleft palate repair surgeries may cause the bones in the middle of a baby's face to not correctly grow and may also alter the connection between their mouth and nose. However, most infants heal without any complications or problems.
How a baby will look after a cleft palate repair surgery depends on how serious their defect was. They may require another operation to fix their scar. Additionally, a baby may need to visit a dentist as their teeth may need to be corrected as they come in. After a repair surgery, a child that had cleft palate may also still have problems with speech and hearing, and may need to have regular hearing tests and speech therapy.
If your baby was born with an oral birth defect because of Topamax, you may have many questions regarding when you can receive compensation for medical expenses and pain and suffering. If you have taken Topamax or another drug and believe its use caused your child to be born with a birth defect, contact the Topamax cleft palate lawyers at Anapol Schwartz. We can help you determine if you have a valid claim. For a free consultation, call 1-866-735-2792.