Skip to Content
Living with relapsing MS? Don’t miss these free events >>

Vigabatrin Pregnancy and Breastfeeding Warnings

Vigabatrin is also known as: Sabril

Vigabatrin Pregnancy Warnings

Animal studies have revealed evidence of developmental toxicity, including teratogenic effects, an increased incidence of malformations (cleft palate), embryofetal death, decreased fetal body weights, increased incidences of fetal anatomic variations, neurobehavioral (convulsions, neuromotor impairment, learning deficits), and neurohistopathological (brain vacuolation, decreased myelination, and retinal dysplasia) abnormalities. A limited amount of data from spontaneous reports of exposed human pregnancies have shown congenital anomalies or spontaneous abortion in the offspring of mothers taking this drug; however, definite conclusions cannot be drawn due to inherent limitations of such data (e.g., concomitant use of other antiepileptic drugs). There are no controlled data in human pregnancy. To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients 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 AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: D US FDA pregnancy category: C Comments: -Specialist advice should be provided to all women of childbearing potential. -The need of antiepileptic treatment should be reevaluated when a patient plans a pregnancy. -It is recommended that antiepileptic drugs should be continued during pregnancy, if possible as monotherapy and at the lowest effective dose; women should be apprised of the potential hazards to the fetus. -Women should take folic acid 5 mg daily starting 4 weeks before conception and during the first 12 weeks of pregnancy, and be offered specialist antenatal screening including ultrasound scanning.

See references

Vigabatrin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (in low concentrations) Comments: -The effects in the nursing infant are unknown.

Limited information indicates that maternal doses of this drug up to 2000 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Until more data are available, this drug should only be used with careful monitoring during breastfeeding.

See references

References for pregnancy information

  1. "Product Information. Sabril (vigabatrin)." Lundbeck Inc, Deerfield, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Sabril (vigabatrin)." Lundbeck Inc, Deerfield, IL.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and 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 material 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 combination thereof in no way should be construed to indicate that the drug or 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 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.