Tiagabine Pregnancy and Breast Feeding Warnings
Tiagabine is also known as: Gabitril
Overview
Tiagabine may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tiagabine while you are pregnant. It is not known if Tiagabine is found in breast milk. If you are or will be breast-feeding while you use Tiagabine , check with your doctor. Discuss any possible risks to your baby.
Tiagabine Pregnancy Warnings
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.
Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.
Tiagabine Lactation Warnings
There are no data on the excretion of tiagabine or its metabolites into human milk. The effects in the nursing infant are unknown.
Tiagabine and its metabolites have been shown to pass into the milk of lactating rats.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This drug information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information in contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
