Eslicarbazepine Pregnancy and Breastfeeding Warnings

Brand names: Aptiom

Medically reviewed by Drugs.com. Last updated on Oct 30, 2023.

Eslicarbazepine Pregnancy Warnings

Benefit should outweigh risk

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

Risk Summary: Limited data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes; based on animal data, this drug may cause fetal harm.

Comments:
-If a woman becomes pregnant, she should be advised of the potential risk to a fetus.
-There are risks related to epilepsy and antiepileptic therapy in pregnant women; the advise of specialists should be provided to women of childbearing potential, especially those who are planning to become pregnant.
-This drug interacts with oral contraceptives; an alternative and effective method of contraception should be used during treatment and up to the end of the current menstrual cycle after discontinuing treatment.
-Patients should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry if they become pregnant: To enroll, patients can call 1-888-233-2334; information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Animal studies have revealed evidence of developmental toxicity. Studies conducted in pregnant mice, rats, and rabbits, have revealed developmental toxicity at clinically relevant doses, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species). The prevalence of malformations in babies born to women with epilepsy has been estimated to be 2 to 3 times greater than general population. Cleft lip, cardiovascular malformations, and neural tube defects are the more frequently reported malformations. Use of combination drug therapy may be associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy is preferred whenever possible. No sudden discontinuation of AED therapy should occur during pregnancy as this may lead to breakthrough seizures which could have serious consequences for both mother and child. Folic acid supplementation is recommended before and during pregnancy as AED therapy may contribute to folic acid deficiency. Bleeding disorders in the newborn have occurred because of maternal AED use, and therefore vitamin K1 is recommended in the last few weeks of pregnancy. There are no controlled data in human pregnancy.

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.

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Eslicarbazepine Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-No information is available on use of this drug during breastfeeding; however, there is some information on the active metabolite, oxcarbazepine; limited information suggests that oxcarbazepine would not be expected to cause adverse effects in breastfed infants, particularly if the infant is over 2 months of age.
-If this drug is used during breastfeeding, monitor breastfed infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and with use of combination anticonvulsants.
-Some authorities recommend breastfeeding be discontinued with maternal use of this drug as a risk to the breastfed infant cannot be excluded.

See references

Further information

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