Oxtellar XR and Pregnancy
Is it safe for pregnant women to take Oxtellar XR (oxcarbazepine extended-release)? Although this drug has not been studied in pregnant women, animal research suggest that the active ingredient in this drug could cause miscarriages and defects of the face, skull, heart, and skeleton. Due to these and other possible problems, talk to your healthcare provider before taking this drug.
Oxtellar XR™ (oxcarbazepine extended-release) is a prescription anti-seizure medication. Based on the results of animal studies, it may not be safe for use during pregnancy, although the full risks are not entirely known.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Oxtellar XR is classified as a pregnancy Category C medicine.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Oxtellar XR has not been studied in pregnant women. In animal studies, the drug increased the risk for birth defects when given to pregnant rats, including defects of the face, skull, heart, and skeleton. It also caused miscarriages and reduced the growth of the unborn rats. When given to pregnant rabbits, Oxtellar XR did not cause birth defects, but did cause miscarriages.
Oxtellar XR is similar in structure to another anti-seizure medication known as carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®). Carbamazepine is known to cause birth defects in humans. Animal studies in mice suggest that Oxtellar XR is associated with a lower risk for birth defects than carbamazepine.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
There are a few reports describing the use of oxcarbazepine (the active ingredient in Oxtellar XR) during pregnancy. Blood levels of oxcarbazepine were high enough to be detected in a newborn whose mother took oxcarbazepine during pregnancy, indicating the drug passes from a mother to her unborn child.
There have also been reports of mild facial defects occurring in infants born to mothers who took oxcarbazepine during pregnancy, including widening of the base of the nose and distinct skin folds in the inner corner of the eye. However, no major birth defects have been reported from the use of the medication. At this time, however, there is not enough information available on the use of Oxtellar XR during pregnancy to fully assess all of the possible risks to an unborn child.
Due to changes that occur in the body during pregnancy, blood levels of Oxtellar XR may gradually decrease throughout pregnancy and increase again after delivery. Therefore, if you are treated with this drug during pregnancy, you will need to be carefully monitored both during pregnancy and through the postpartum period (the first six weeks after giving birth, at least).
Also, if you become pregnant during Oxtellar XR treatment, ask your healthcare provider about enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of using anti-seizure medications during pregnancy.
(Click Epilepsy and Pregnancy for more general information about this condition during pregnancy.)