Topiramate may increase clefts in babies
Topiramate is a medication used to treat epilepsy. But it’s also considered for treatment of sleep and eating disorders, other psychiatric conditions, and weight loss. Topiramate is also a component of Qsymia, a medicine which was approved by the Food and Drug Administration (FDA) on 7/17/2012 for chronic weight management.
Topiramate is currently considered a Category D medication by the FDA. This means that potential risks of using the medicine during pregnancy have been recognized, but benefits of the medicine (example: controlling epilepsy) may warrant use despite the risks.
A new study looked at the risk of oral clefts (cleft lip and cleft palate) in infants whose mothers took topiramate during the first trimester of pregnancy. It used data from two large birth defects case-control studies. Both studies showed an increased risk of oral clefts in infants exposed to topiramate during the first trimester compared to infants not exposed to antiepileptic medicines.
Previous studies have shown a potential association between oral clefts and the use of topiramate during pregnancy. However, this association has been hard to evaluate because both the use of topiramate during pregnancy and the occurrence of oral clefts are rare.
This new study supports previous findings showing an increased risk of oral clefts among infants exposed to topiramate. Assuming this study is correct, this means that for any pregnancy exposed to topiramate, the risk of oral clefts in the offspring would be increased 5-fold. This shouldn’t make anyone panic, however, because oral clefts are a rare occurrence. It is important to keep the absolute risks in mind. Approximately 1 in 1,000 infants is born with cleft lip/palate in the US each year, and for any topiramate-exposed pregnancy, the risk would increase to approximately 5 in 1,000 infants.
If you have questions about the safety of any medications during pregnancy, speak with your health care provider, check out this CDC website or contact the Organization of Teratology Information Specialists.