Topamax, or topiramate, is a medication used to treat seizures, particularly those that arise as a result of epilepsy. Topamax is also often prescribed to relieve the pain of migraine headaches. While this medication is quite effective as an anticonvulsant, it has been linked to a number of side effects, including those that can damage babies born to women that took Topamax while pregnant.
In particular, the primary danger of taking Topamax during pregnancy is that babies may develop a cleft lip or cleft palate. While these birth defects are normally very rare, they are 20 times more likely to occur in babies born to mothers taking the medication. These defects result in either the appearance of a split lip, or, in the worst case, a hole in the roof of the mouth, which can prevent a baby from receiving nutrition adequately. As a result of inadequate nutrition, babies can subsequently have development issues that can include further health problems. These conditions do not resolve themselves, and while they can be successfully treated with surgery, many times, a succession of several operations is required.
The risk of babies getting cleft palate is supported by scientific research, and in March of 2011, the U.S. Food and Drug Administration sent out a warning to patients taking the medication, as well as health care practitioners, stating that research shows a conclusive link between taking Topamax while pregnant and an increased risk of cleft palate in babies.
Cleft lip and cleft palate usually begin developing in infants during the first three months of pregnancy. Since this period of time is when many expectant mothers do not know that they are pregnant, the FDA felt that it was important that doctors should notify female patients of childbearing age taking Topamax of the risk, in case they should suddenly become pregnant.
Additionally, the FDA advised doctors to use caution when prescribing Topamax to women old enough to bear children for this same reason, and recommended that other medications for seizures and migraines be considered for this group of patients.
The North American Antiepileptic Drug Baby Registry collected the data that the FDA used to come to their decision. Normally, cleft lip or cleft palate only occurs in 0.07 percent of infants. The percent of infants with these birth defects born to women that took Topamax while pregnant was 1.4, and women taking other antiepileptic drugs during pregnancy had babies with birth defect rates of 0.38 to 0.55 percent. In January, the FDA had requested that Vivus Inc., the manufacturer of Topamate, perform studies to determine the risk of these birth defects arising in infants exposed to the drug.
In addition to the brand Topamax, the active drug, topiramate, is also found in its generic form and made by several different manufacturers.
