Gabitril and Pregnancy
In animal studies on Gabitril and pregnancy, the drug was linked to problems such as birth defects, stillbirths, and miscarriages. As a result, the FDA classifies Gabitril as a pregnancy Category C drug. However, if a woman is taking Gabitril and pregnancy occurs, her healthcare provider may have her continue the drug if the benefits outweigh the risks.
Is Gabitril Safe During Pregnancy?Gabitril® (tiagabine hydrochloride) may not be safe for women who are pregnant. In animal studies that evaluated the effects of Gabitril use during pregnancy, the drug caused birth defects, miscarriages, and growth problems.
Gabitril and Pregnancy Category CThe U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medications that have not been studied in pregnant humans but that appear to cause harm to the fetus in animal studies. Also, medications that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Gabitril was given a pregnancy Category C rating due to problems seen in animal studies. When given to pregnant rats, the medication increased the risk of birth defects (including head, face, and other defects). It also caused low fetal weight and increased the risk of stillbirth. In pregnant rabbits, Gabitril increased the risk of miscarriages
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child. Gabitril may not be the best choice for pregnant women with epilepsy, as it is intended to be used only in combination with other seizure medications. It is generally accepted that taking a single seizure medication (rather than two or more) is best for pregnant women.