Felbamate Pregnancy and Breastfeeding Warnings

Brand names: Felbatol

Medically reviewed by Drugs.com. Last updated on Apr 28, 2025.

Felbamate Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of decreased weight in offspring and an increase in offspring deaths during lactation. Studies have also revealed placental transfer of this drug. The incidence of malformations was not increased compared to control in offspring of animals given doses several times higher than the therapeutic human daily dose on a mg/kg basis. 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 with the NAAED Pregnancy Registry by visiting http://www.aedpregnancyregistry.org/.

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

Felbamate Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comment:
-The effect in the nursing infant is unknown.

Because no information is available on the use of this drug during breastfeeding, and because it can potentially cause fatal hematologic and hepatic toxicities, most experts recommend that mothers do not breastfeed during therapy.

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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