Retrospective Analysis of Oxcarbazepine in Pregnant Women With Substance Use Disorders: Focus on Safety

Abstract

Background: Published safety data in pregnant epileptic women suggests that oxcarbazepine (OXC) may be a treatment option in nonepileptic pregnant women with substance use disorders (SUDs) and psychiatric symptomatology. Objective: To compare safety outcomes associated with OXC exposure versus non-exposure in nonepileptic pregnant women with SUD and comorbid psychiatric symptomatology. Methods: A retrospective chart review was conducted to identify pregnant women 18 years or older with a SUD who delivered at the study site. Exclusion criteria included a current diagnosis of epilepsy/seizure disorder; concurrent use of lithium, anticonvulsants, medications with a Risk Evaluation and Mitigation Strategy program or a black box warning for potential fetal toxicity; and multi-parity. Eligible patients were divided into two groups based on OXC exposure. Results: The OXC group included 94 mother-neonate pairs versus 194 mother-neonate pairs in the non-OXC group. Baseline characteristics differed in mean number of prior pregnancies (2.8 vs 2.2 in the OXC and non-OXC group, respectively, P = .03). No significant differences were found regarding emergent cesarean or maternal hyponatremia. Average gestational age at OXC initiation was 19.8 weeks. No significant differences were found in the rates of prematurity, physical characteristics, malformation, and neonatal abstinence syndrome. Conclusion: OXC may be considered for management of SUD with comorbid psychiatric symptomatology in nonepileptic pregnant women. Further studies should be conducted to determine statistical significance in larger sample sizes.

Adverse fetal and neonatal outcomes following in‐utero exposure to oxcarbazepine: A systematic review and meta‐analysis

“…Two studies 32,43 reported an incidence of urogenital malformations following in‐utero exposure to oxcarbazepine. Development of neonatal abstinence syndrome following oxcarbazepine treatment was reported by Johnson et al 42 Various perinatal complications, including C‐section delivery, perinatal death, premature birth, low birth weight, etc., were reported by six studies 30,42 . Learning and language disabilities, developmental disorders and spina bifida were among the major neural outcomes encountered after in‐utero oxcarbazepine exposure 33–36 …”

“…There was no loss of follow-up and confounding factors like maternal age, parity, socioeconomic status, etc., were adjusted in the analysis. A study that included singleton liveborn infants born to women enrolled in the North American Antiepileptic Drug Pregnancy Registry between 1997 and 2016 reported the rate of preterm deliveries in epileptic women who used AEDs to be 9.3%, 51 which was comparable to the risk established by Johnson et al 42 A meta-analysis is only as good as the studies included in it. We devised a comprehensive search strategy, utilized many online databases, and applied no time or location restrictions to ensure selection of the maximum number of articles with information pertaining to our review.…”

“…A total of three studies 30,38,42 calculated the rates of preterm deliveries after oxcarbazepine exposure during pregnancy ranging from 2.85% to 10.6%. Artama et al 38 studied the outcome using women without epilepsy and AED exposure as a control group.…”

“…We included 19 cohort studies, 16,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] of which 16 (84.2%) were prospective and three (15.8%) were retrospective published between 1991 and 2021. The majority of the studies were based in Europe (11/19, 57.9%), followed by North America (3/19, 15.8%), Asia (2/19, 10.5%), Oceania (2/19, 10.5%) and South America (1/19, 5.3%).…”

Bipolar Disorder and Polysubstance Use Disorder: Sociodemographic and Clinical Correlates

“…A recent review explored the use of gabapentin and pregabalin in the treatment of patients with BD, indicating a potential role of these medications in the management of SUD comorbidity ( 71 ). Similarly, oxcarbazepine has been proposed as an alternative treatment for SUD during pregnancy ( 72 ), but with scarce evidence for the treatment of SUD in comorbidity with BD ( 73 ). The increased prevalence of polypharmacy, particularly benzodiazepines and other drugs, in patients suffering from BD and polySUD should be framed as an attempt to reduce abstinence, treat residual symptoms as sleep or anxiety derived from potential subsyndromal psychotic symptoms, or recognize the need for better mood stabilization.…”