Vigabatrin Pregnancy and Breastfeeding Warnings

Brand names: Sabril, Vigadrone, Vigafyde, Vigpoder

Medically reviewed by Drugs.com. Last updated on Sep 3, 2024.

Vigabatrin Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk. Based on animal data, may cause fetal harm.

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.
-A pregnancy exposure registry is available.

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 monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by visiting http://www.aedpregnancyregistry.org/.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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