Placental transfer of this drug occurs in animal studies. 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. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients enroll in the 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/.

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.

US FDA pregnancy category: C

See references

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