According to a recent release by the Food and Drug Administration (FDA), the epilepsy drug Topamax has been associated with the development of oral cleft birth defects like cleft palate and cleft lip. The study suggests that the increased risk of cleft lip and cleft palate might be as much as 16 times higher than those not taking Topamax while pregnant.
A study conducted by the North American Antiepileptic Drug Pregnancy Registry discovered that approximately 1.4% of infants whose mothers were on Topamax during the first trimester of pregnancy developed oral clefts like cleft palate or cleft lip. Approximately .4% of children developed oral cleft birth defects whose mothers were on different epilepsy drugs. Only .07% of infants whose mothers were not on epilepsy medication during pregnancy developed oral cleft birth defects like cleft lip or cleft palate.
A cleft lip often looks like a hole or indentation in the lip which can possibly extend all the way to the nose. A cleft lip can happen on either side of the mouth, or even on both sides. In some cases, cleft lip can be detected via prenatal ultrasound, but more often than not, cleft lip is diagnosed during a physical exam after birth.
An earlier study released in the journal Neurology stated that the rate of children who had developed cleft lip is 11 times higher in those whose mothers took Topamax while they were pregnant. Cleft lip is treatable, but it may require multiple surgeries beginning as early as 3 months after birth. In some cases, treatment for a cleft lip might extend into a patient’s teenage years.
A cleft palate forms when certain plates in the skull which are meant to form a hard palate, or the mouth’s roof, don’t form correctly. Cleft palate can cause a hole or gap in the roof of the mouth or between the soft and hard palate, potentially causing a hole in the patient’s jaw.
Usually an infant will only develop either a cleft lip or a cleft palate, but in some cases, both cleft lip and cleft palate can be present at the same time. There are operations which fix cleft palate by refusing the palate and nasal passage. Typically this surgery is supposed to be undergone before an infant is a year old. In some cases of cleft palate, the infant may need a tube to be inserted into their ear prior to the surgery to avoid hearing loss.
In most cases, oral clefts like cleft lip and cleft palate will develop within the first trimester of pregnancy. The following are some examples of potential complications resulting from oral cleft disorders:
Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The antidepressant Topamax may be linked to causing the development of birth defects in unborn babies, infants, and children when their mothers took antidepressants while pregnant.
Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Topamax cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an antidepressant like Topamax during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).