Topamax Cleft Palate a Serious Side Effect of Anticonvulsant Drug

On March 4, 2011, the FDA notified patients and healthcare professionals of serious Topamax birth defects. The anticonvulsant drug, prescribed to treat epilepsy and seizures, and also used as a migraine medication, has been found to increase the risk of Topamax cleft palate and cleft lip when taken by pregnant women. The FDA advised pregnant women and women of childbearing age to discuss carefully with their healthcare providers other treatment options, to avoid the risk. Unfortunately, the warning comes too late for many women who have already had children with Topamax cleft palate, and now must turn to a Topamax lawyer for advice.

What is Topamax Cleft Palate?

Cleft lip and cleft palate, which can occur separately or together, are types of congenital birth defects that arise when the roof of the baby’s mouth (palate) develops abnormally. The term “cleft” refers to an opening or gap that develops somewhere in the palate, sometimes going through to the nasal cavity. This opening is the result of the body’s structures—specifically, the two plates of the skull that form the roof of the mouth—failing to fuse and close as they normally would before birth.

A cleft lip also refers to an opening or gap, this time in the baby’s lip. It may appear just in the lip itself, or may continue up to the nose, sometimes on two sides.

Left untreated, cleft lip and palate can cause feeding problems, nasal whistling when talking, speech difficulties, hearing problems, and psychosocial challenges. Fortunately, surgery can usually correct the problem, though some children may experience lasting effects like speech and hearing difficulties, dental issues, and sinus and ear infections.

Studies Reveal Topamax Cleft Palate

Topamax was originally classified by the FDA as a “Category C” drug, which means that animal studies suggested risk of Topamax birth defects, but no human data had confirmed it. Recently, however, that classification was changed to a “Category D,” which means there is now positive evidence based on human studies that show Topamax raises the risk of birth defects.

The FDA based its new classification on data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which showed an increased risk of oral clefts in infants exposed to Topamax (topiramate) during early pregnancy. In fact, 1.4 percent of babies born to mothers taking Topamax had oral clefts, compared to 0.38 – 0.55 percent in mothers taking other antiepileptic drugs, and only 0.07 percent in mothers who took no epileptic drugs at all.

An earlier study published in Neurology (2008) found a similar connection, with the rate of Topamax cleft palate defects eleven times higher than the average rate of cleft palate among the general population.

Topamax and Pregnancy

In addition to cleft lip and palate, Topamax birth defects may also include abdominal defects and cranial defects. Though healthcare professionals advise against stopping Topamax without a doctor’s supervision, women who are thinking about having a child, who suspect they may be pregnant, or who are pregnant, should talk to their doctor about the potential for Topamax birth defects, and about finding a safer alternative medication.

Topamax Lawsuit May Result in Compensation

If your child was born with a birth defect, particularly a cleft lip or palate, and you took Topamax during the first trimester, a Topamax lawyer can help determine the potential for your claim in a Topamax lawsuit.  Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123