Oxcarbazepine Pregnancy and Breastfeeding Warnings

Oxcarbazepine is also known as: Oxtellar XR, Trileptal

Oxcarbazepine Pregnancy Warnings

One study has reported that oxcarbazepine is metabolized into its 10 hydroxy derivative to some extent in human placenta in vitro suggesting that the placenta also participates in the metabolism of oxcarbazepine in vivo. To provide information regarding the effects of in utero exposure to oxcarbazepine, physicians are advised to recommend that pregnant patients taking oxcarbazepine enroll in the North American Antiepileptic Drug (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/.

Oxcarbazepine has been assigned to pregnancy category C by the FDA. Animal studies have revealed increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation), fetal malformations (craniofacial, cardiovascular, and skeletal), embryofetal death, decreased fetal body weight, and maternal toxicity. There are no controlled data in human pregnancy. Oxcarbazepine should only be given during pregnancy when benefits outweigh risks.

Oxcarbazepine Breastfeeding Warnings

Oxcarbazepine and its active 10-monohydroxy metabolite are excreted into human breast milk. Because of the potential for serious adverse reactions to oxcarbazepine in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug in nursing women, taking into account the importance of the drug to the mother.

In previous studies, the milk to plasma ratio has been estimated to be 0.5 for oxcarbazepine and 0.5 to 0.8 for 10-hydroxycarbazepine. A recent case report has noted milk to plasma ratios of oxcarbazepine at 9 and 5, and 10-hydroxycarbazepine at 0.77 and 0.92, at 8 days postpartum and 23 days postpartum respectively.

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