Tiagabine Pregnancy and Breastfeeding Warnings

Tiagabine is also known as: Gabitril

Tiagabine Pregnancy Warnings

To provide information regarding the effects of in utero exposure to tiagabine, physicians are advised to recommend that pregnant patients taking tiagabine enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Tiagabine has been assigned to pregnancy category C. High dose reproductive studies conducted with rats and rabbits have demonstrated teratogenic effects (craniofacial, appendicular, and visceral malformations), maternal toxicity (transient weight loss or reduced maternal weight gain during gestation), as well as adverse fetal outcome when the drug is administered during late gestation and throughout parturition (increase in stillbirths and decrease in postnatal offspring viability). No adverse fetal or maternal effects were observed with doses equivalent to three times the maximum recommended human dose on a mg/m2 basis. There are no controlled data in human pregnancy. Tiagabine should only be given during pregnancy when need has been clearly established.

Tiagabine Breastfeeding Warnings

Tiagabine and its metabolites have been shown to pass into the milk of lactating rats.

There are no data on the excretion of tiagabine or its metabolites into human milk. The effects in the nursing infant are unknown.

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