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Eslicarbazepine Pregnancy and Breastfeeding Warnings

Eslicarbazepine is also known as: Aptiom

Eslicarbazepine Pregnancy Warnings

-Animal studies revealed evidence of developmental toxicity including teratogenicity, embryolethality, and fetal growth retardation. 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. 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 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.

Potential benefit should outweigh the potential risk. US FDA pregnancy category: Not assigned. Comments: -The lowest effective dose should be used and monotherapy is preferred at least during the first trimester. Therapy should not be abruptly discontinued as this may lead to breakthrough seizures. -Folic acid supplementation is recommended before and during pregnancy. -Bleeding disorders in the newborn have occurred because of maternal antiepileptic therapy; therefore, vitamin K1 should be administered in the last few weeks of pregnancy and to the newborn. -This drug can significantly decrease the effectiveness of hormonal contraceptives. Advise female patients of childbearing potential to use additional or alternative nonhormonal forms of contraception during therapy and for at least one menstrual cycle after discontinuing therapy.

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: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Aptiom (eslicarbazepine)." Sunovion Pharmaceuticals Inc, Marlborough, MA.

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