Is Trileptal (Oxcarbazepine) safe during pregnancy?

From the Guidelines

Trileptal (oxcarbazepine) should be used with caution during pregnancy, as it is associated with a slightly increased risk of birth defects, and the benefits of treatment must outweigh the potential risks. When considering the use of Trileptal during pregnancy, it is essential to weigh the risks and benefits, particularly for women with epilepsy who require seizure control. According to the provided evidence, certain anticonvulsants, including oxcarbazepine, are classified as category 3, indicating that the interaction with combined oral contraceptives (COCs) is likely to reduce their effectiveness 1. However, this evidence does not directly address the safety of Trileptal during pregnancy.

To minimize potential risks, women taking Trileptal during pregnancy should:

• Take a higher dose of folic acid (4-5 mg daily) before conception and throughout pregnancy to reduce the risk of neural tube defects
• Be monitored for vitamin K deficiency in newborns, and vitamin K supplementation may be recommended
• Use the lowest effective dose of Trileptal, and blood levels should be monitored regularly during pregnancy as metabolism changes may require dose adjustments
• Never stop taking Trileptal suddenly without medical supervision, as this could trigger seizures

It is crucial for women taking Trileptal who are pregnant or planning pregnancy to discuss their specific situation with their neurologist and obstetrician to create an individualized treatment plan. While the provided evidence does not directly address the safety of Trileptal during pregnancy, the general principles of using anticonvulsants during pregnancy can be applied, prioritizing the control of seizures and minimizing potential risks to the fetus 1.

From the FDA Drug Label

There are no adequate data on the developmental risks associated with the use of oxcarbazepine in pregnant women; however, oxcarbazepine is closely related structurally to carbamazepine, which is considered to be teratogenic in humans Data on a limited number of pregnancies from pregnancy registries suggest that oxcarbazepine monotherapy use is associated with congenital malformations (e.g., craniofacial defects such as oral clefts and cardiac malformations such as ventricular septal defects) Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (MHD) during pregnancy at doses similar to the maximum recommended human dose (MRHD) Oxcarbazepine tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking oxcarbazepine tablets You and your healthcare provider will decide if you should take oxcarbazepine tablets while you are pregnant

Oxcarbazepine use during pregnancy is not considered safe due to the potential risk of congenital malformations and developmental toxicity. The decision to use oxcarbazepine during pregnancy should be made after careful consideration of the potential benefits and risks, and under the guidance of a healthcare provider 2. Key points to consider:

• Oxcarbazepine is structurally related to carbamazepine, which is known to be teratogenic in humans
• Limited data from pregnancy registries suggest an association between oxcarbazepine use and congenital malformations
• Animal studies have shown increased incidences of fetal structural abnormalities and developmental toxicity at doses similar to the maximum recommended human dose
• Healthcare providers should carefully weigh the potential benefits and risks of oxcarbazepine use during pregnancy and monitor patients closely 2

From the Research

Trileptal (Oxcarbazepine) Safety During Pregnancy

• The safety of Trileptal (oxcarbazepine) during pregnancy has been studied in several research papers 3, 4, 5, 6, 7.
• According to a study published in 2020, oxcarbazepine's active metabolite licarbazepine has decreased concentrations during pregnancy due to increased clearance 3.
• A 2011 study found that first-trimester exposure to oxcarbazepine was not associated with an increased risk of major birth defects, with 11 out of 393 infants (2.8%) exposed to oxcarbazepine diagnosed with a major birth defect 5.
• Another study published in 2012 noted that oxcarbazepine is one of the newer-generation antiepileptic drugs with favorable safety issues during pregnancy 6.
• A 2018 study compared the efficacy of oxcarbazepine with other antiepileptic drugs during pregnancy and found that it provides similar seizure control to older antiepileptic drugs 7.
• However, it is essential to monitor the trough concentrations of oxcarbazepine during pregnancy, as its clearance may increase, and dose adjustments may be necessary to maintain therapeutic levels 3.

Key Findings

• Oxcarbazepine's active metabolite licarbazepine has decreased concentrations during pregnancy due to increased clearance 3.
• First-trimester exposure to oxcarbazepine is not associated with an increased risk of major birth defects 5.
• Oxcarbazepine has favorable safety issues during pregnancy 6.
• Oxcarbazepine provides similar seizure control to older antiepileptic drugs 7.
• Monitoring of oxcarbazepine trough concentrations during pregnancy is recommended to maintain therapeutic levels 3.