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Gabitril®
 

Pregnancy and Gabitril

The FDA lists tiagabine in Pregnancy Category C. This indicates that caution is advised, but the benefits of the medication may outweigh the potential risks. There have been no well-controlled studies in women, but studies in animals have shown some harm to the fetus.

The risk of birth defects is generally higher for women who take more than one AED and for women with a family history of birth defects.

Advise women who are capable of becoming pregnant to take at least 400 mcg (0.4 mg) of folic acid (folate) daily to help prevent neural tube defects. Women at high risk, such as those with a history of a neural tube defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant. The effectiveness of prophylactic folic acid use in preventing defects related to Gabitril has not been proven, however, so diagnostic ultrasonography at the 18th to 20th week is recommended, especially if pregnancy termination is an option.

About 20% to 35% of women have seizures more often during pregnancy because of changes in hormones or changes in how their seizure medication is handled by the body. Whether this applies to Gabitril is uncertain, and blood levels are of limited value because of the short half-life of Gabitril. Therefore doses in pregnant women should be adjusted based on clinical response.

Breast-feeding by mothers taking Gabitril should generally be safe for healthy, full-term newborns, although a very small amount of the medication will appear in the milk.