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Eslicarbazepine Pregnancy and Breastfeeding Warnings

Eslicarbazepine is also known as: Aptiom

Eslicarbazepine Pregnancy Warnings

-Animal studies have revealed evidence of developmental toxicity including teratogenicity, embryolethality, and fetal growth retardation at clinically relevant doses. There are no controlled data in human pregnancy. -In the offspring of women with epilepsy, the prevalence of malformations is 2 to 3 times greater than the rate of approximately 3% in the general population. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Multiple drug therapy may be associated with a higher risk of congenital malformations than monotherapy; therefore, it is important that monotherapy is used whenever possible. Specialist advice should be given to women who are likely to become pregnant or who are of child-bearing potential. The need for antiepileptic therapy should be reviewed when a woman is planning to become pregnant. Therapy should not be abruptly discontinued as this may lead to breakthrough seizures which could have serious consequences for both mother and child. -This drug can significantly decrease the effectiveness of hormonal contraceptives. Female patients of childbearing potential should be advised to use additional or alternative nonhormonal forms of contraception during treatment and after treatment is discontinued for at least one menstrual cycle. 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. Physicians are advised to recommend that pregnant patients taking this drug enroll in the North American Antiepileptic Drug Pregnancy Registry. This can be done by calling 1-888-233-2334 (toll-free), and must be done by patients themselves. Information on the registry can also be found at the website

Potential benefit should outweigh the potential risk. US FDA pregnancy category: C Comments: -The lowest effective dose should be used and monotherapy is preferred at least during the first trimester. -Folic acid supplementation is recommended before and during pregnancy. Bleeding disorders in the newborn have occurred as a result of maternal antiepileptic therapy; therefore, vitamin K1 should be administered in the last few weeks of pregnancy and to the newborn.

See references

Eslicarbazepine 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 The effects in the nursing infant are unknown.

-No information is available on the use of this drug during breastfeeding; however, it is the active metabolite of oxcarbazepine. Limited information indicates that oxcarbazepine would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. -If this drug is used during breastfeeding alone or in combination with other anticonvulsants, the infant should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants.

See references

References for pregnancy information

  1. "Product Information. Aptiom (eslicarbazepine)." Sunovion Pharmaceuticals Inc, Marlborough, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  3. "Product Information. Aptiom (eslicarbazepine)." Sunovion Pharmaceuticals Inc, Marlborough, MA.

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