Topiramate is associated with which FDA Pregnancy Risk category?

Topiramate is classified as a FDA Pregnancy Risk Category D drug. This classification indicates that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits of the drug may warrant its use in pregnant women despite potential risks.

In the case of topiramate, it has been associated with an increased risk of congenital malformations, such as oral clefts, when taken during the first trimester of pregnancy. This risk emphasizes the importance of careful consideration when prescribing this medication to pregnant patients or those contemplating pregnancy, as the potential benefits must be weighed against the risks to the developing fetus. Understanding the implications of this categorization is crucial for healthcare providers when discussing treatment options with patients who are pregnant or may become pregnant.