Topiramate-containing drugs are most often used to ease epilepsy and migraines, but Topamax related birth defects have made this a dangerous course of treatment for pregnant women. Although the substance was approved in 1996 by the FDA, several medical studies have since proven it is capable of causing major health complications. In March 2011, the FDA pushed the medication from pregnancy category C to pregnancy category D, citing research that showed an increased risk of cleft lip and cleft palate.
In 2008, a study was published in the peer-reviewed medical journal Neurology. In this study, several researchers reviewed the UK epilepsy and pregnancy register and found Topamax caused birth defects in many children. In all, 178 live births were studied for effects of the drug. Of the 178, 16 were born with major congenital malformation. Most of these were cleft lip and palate, though some were also born with hypospadias, a urethra malformation in male children. The study concluded that the incidence rate of cleft lip and palate in these children was 11 times higher than children whose mothers had not taken the drug.
Even though topiramate is in pregnancy category D, which means there is a proven link between the medication and human fetal abnormalities, it is still approved for use in many cases. In 2012, the FDA approved its use for weight loss. The agency estimates that around 32 million prescriptions for the drug have been filled, and its extensive off-label use means that many of these prescriptions were likely given to pregnant women.
Any woman who has had a child with topiramate related abnormalities should think about contacting an attorney that specializes in drug injury cases.