Oxcarbazepine exposure during pregnancy ups risk of malformations, foetal death

Exposure to oxcarbazepine during pregnancy is associated with congenital malformations and even foetal/perinatal death, suggest the results of a systematic review and meta-analysis.

“Our systematic review will help healthcare providers and guideline developers regarding the treatment of epilepsy and other neurological disorders during pregnancy,” the investigators said.

The systematic review used different online source such as Medline, Cochrane Library, and Virtual Health Library, among others, and identified observational studies of women who took oxcarbazepine anytime during pregnancy. Non-English articles, reviews, meta-analyses, case reports, and animal studies were excluded.

The investigators assessed risk of bias in observational studies using the Newcastle-Ottawa Scale and performed the meta-analyses using a random-effect model. They also evaluated the quality of evidence for the primary outcomes using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE).

Nineteen cohort studies with a total of 5,071,137 patients were included in the meta-analysis. Of the participants, 2,450 had exposure to oxcarbazepine either as monotherapy or polytherapy.

In-utero exposure to oxcarbazepine increased the likelihood of congenital malformations by 69 percent (odds ratio [OR], 1.69, 95 percent confidence interval [CI], 0.95‒2.98) when compared to unexposed patients (seven studies, n=625), and by 19 percent (95 percent CI, 0.67‒2.12) when compared to those following lamotrigine exposure during pregnancy (three studies, n=591).

Three studies (n=770) also found an association between in-utero oxcarbazepine exposure and foetal/perinatal deaths. The meta-analysis generated a summary OR of 3.33 (95 percent CI, 1.70‒6.51).

“More cohort studies with a higher sample size concerning oxcarbazepine use in pregnant patients are required to truly assess the in-utero safety profile of the drug,” the investigators said.