Buprenorphine With Naloxone May Be Safe During Pregnancy for OUD Treatment
When compared to buprenorphine alone, buprenorphine with naloxone during pregnancy may also be a safe treatment option for patients with opioid use disorder (OUD), according to results from a population-based cohort study published in JAMA.
“This study observed similar and, in some instances, more favorable neonatal—particularly for neonatal abstinence syndrome—and maternal outcomes for pregnancies exposed to buprenorphine combined with naloxone compared with buprenorphine alone,” authors noted. “This supports the view that both formulations are reasonable options for treatment of OUD in pregnancy, affirming flexibility in collaborative treatment decision-making.”
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Researchers used health care utilization data from Medicaid-insured beneficiaries in the US from 2000 to 2018. The cohort was restricted to pregnant individuals linked to their liveborn infants, with maternal Medicaid enrollment from 3 months before pregnancy to 1 month after delivery and infant enrollment for the first 3 months after birth. Researchers studied the use of buprenorphine with naloxone versus buprenorphine alone during the first trimester based on outpatient dispensings.
A total of 3369 pregnant people exposed to buprenorphine with naloxone during the first trimester (mean age 28.8 years) and 5326 exposed to buprenorphine alone or who switched from the combination to buprenorphine alone by the end of the first trimester (mean age 28.3 years) were included in the final results of the study. When comparing buprenorphine combined with naloxone with buprenorphine alone, a lower risk for neonatal abstinence syndrome (absolute risk, 37.4% vs 55.8%; weighted relative risk, 0.77 [95% CI, 0.70-0.84]) and a modestly lower risk for neonatal intensive care unit admission (absolute risk, 30.6% vs 34.9%; weighted relative risk, 0.91 [95% CI, 0.85-0.98]) and small for gestational age (absolute risk, 10.0% vs 12.4%; weighted relative risk, 0.86 [95% CI, 0.75-0.98]) was observed. Comparative maternal morbidity rates were 2.6% vs 2.9%, respectively, and the weighted relative risk was 0.90 (95% CI, 0.68-1.19). No differences were found in major congenital malformations overall, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery, and results were consistent across sensitivity analyses.
Researchers noted a few limitations of their study. Potential obstacles like alcohol use and smoking may be underreported, individuals identified as exposed based on filled prescriptions might not have necessarily used the medication, and there is potential for outcome misclassification.
“Since this study includes a nationwide sample of Medicaid-insured pregnant individuals and most pregnant individuals with OUD in the US are Medicaid insured, the findings are highly generalizable to the pregnant US population receiving buprenorphine treatment for OUD,” authors concluded. “This study illustrates the value of large cohorts nested in health care utilization data to expediently address urgent clinical questions related to OUD treatment safety in pregnancy amid the ongoing opioid epidemic.”
