Comparative Safety of In Utero Exposure to Buprenorphine Combined With Naloxone vs Buprenorphine Alone

Author:

Straub Loreen1,Bateman Brian T.2,Hernández-Díaz Sonia3,Zhu Yanmin1,Suarez Elizabeth A.45,Vine Seanna M.1,Jones Hendrée E.6,Connery Hilary S.78,Davis Jonathan M.9,Gray Kathryn J.10,Lester Barry1112,Terplan Mishka13,Zakoul Heidi1,Mogun Helen1,Huybrechts Krista F.1

Affiliation:

1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

2. Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California

3. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts

4. Center for Pharmacoepidemiology and Treatment Science, Rutgers Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey

5. Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, New Jersey

6. UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill

7. Division of Alcohol, Drugs, and Addiction, McLean Hospital, Belmont, Massachusetts

8. Department of Psychiatry, Harvard Medical School, Boston, Massachusetts

9. Department of Pediatrics, Tufts Medical Center and Tufts Clinical and Translational Science Institute, Boston, Massachusetts

10. Department of Obstetrics and Gynecology, University of Washington, Seattle

11. Center for the Study of Children at Risk, Departments of Psychiatry and Pediatrics, The Warren Alpert Medical School of Brown University, Providence, Rhode Island

12. Women & Infants Hospital, Providence, Rhode Island

13. Friends Research Institute, Baltimore, Maryland

Abstract

ImportanceBuprenorphine combined with naloxone is commonly used to treat opioid use disorders outside of pregnancy. In pregnancy, buprenorphine alone is generally recommended because of limited perinatal safety data on the combination product.ObjectiveTo compare perinatal outcomes following prenatal exposure to buprenorphine with naloxone vs buprenorphine alone.Design, Settings, and ParticipantsPopulation-based cohort study using 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, unless they died sooner.ExposureUse of buprenorphine with naloxone vs buprenorphine alone during the first trimester based on outpatient dispensings.Main Outcomes and MeasuresOutcomes included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity. Confounder-adjusted risk ratios were calculated using propensity score overlap weights.ResultsThis study identified 3369 pregnant individuals exposed to buprenorphine with naloxone during the first trimester (mean [SD] age, 28.8 [4.6] years) and 5326 exposed to buprenorphine alone or who switched from the combination to buprenorphine alone by the end of the first trimester (mean [SD] age, 28.3 [4.5] years). 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. For maternal morbidity, the comparative 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 observed with respect to major congenital malformations overall, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery. Results were consistent across sensitivity analyses.Conclusions and RelevanceThere were similar and, in some instances, more favorable neonatal and maternal outcomes for pregnancies exposed to buprenorphine combined with naloxone compared with buprenorphine alone. For the outcomes assessed, compared with buprenorphine alone, buprenorphine with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for the treatment of opioid use disorder in pregnancy, affirming flexibility in collaborative treatment decision-making.

Publisher

American Medical Association (AMA)

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