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Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study

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Abstract

Introduction and Objective

Receipt of opioid agonist treatment during early and late pregnancy for opioid use disorder may relate to varying perinatal risks. We aimed to assess the effect of time-varying prenatal exposure to opioid agonist treatment using buprenorphine or methadone on adverse neonatal and pregnancy outcomes.

Methods

We conducted a retrospective cohort study of pregnant women with opioid use disorder using Rhode Island Medicaid claims data and vital statistics during 2008–16. Time-varying exposure was evaluated in early (0–20 weeks) and late (≥ 21 weeks) pregnancy. Marginal structural models with inverse probability of treatment weighting were applied.

Results

Of 400 eligible pregnancies, 85 and 137 individuals received buprenorphine and methadone, respectively, during early pregnancy. Compared with 152 untreated pregnancies with opioid use disorders, methadone exposure in both periods was associated with an increased risk of preterm birth (adjusted odds ratio [aOR]: 2.52; 95% confidence interval [CI] 1.07–5.95), low birth weight (aOR: 2.99; 95% CI 1.34–6.66), neonatal intensive care unit admission (aOR, 5.04; 95% CI 2.49–10.21), neonatal abstinence syndrome (aOR: 11.36; 95% CI 5.65–22.82), respiratory symptoms (aOR, 2.71; 95% CI 1.17–6.24), and maternal hospital stay > 7 days (aOR, 14.51; 95% CI 7.23–29.12). Similar patterns emerged for buprenorphine regarding neonatal abstinence syndrome (aOR: 10.27; 95% CI 4.91–21.47) and extended maternal hospital stay (aOR: 3.84; 95% CI 1.83–8.07). However, differences were found favoring the use of buprenorphine for preterm birth versus untreated pregnancies (aOR: 0.17; 95% CI 0.04–0.77), and for several outcomes versus methadone.

Conclusions

Methadone and buprenorphine prescribed for the treatment of opioid use disorder during pregnancy are associated with varying perinatal risks. However, buprenorphine may be preferred in the setting of pregnancy opioid agonist treatment. Further research is necessary to confirm our findings and minimize residual confounding.

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Authors and Affiliations

  1. Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, RI, 02881, USA

    Shuang Wang, Jayne Pawasauskas, Kristina E. Ward, Todd N. Brothers & Xuerong Wen

  2. Department of Neurology, Stanford University, Palo Alto, CA, USA

    Kimford J. Meador

  3. Department of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island, Alpert Medical School of Brown University, Providence, RI, USA

    Adam K. Lewkowitz

  4. Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA

    Abraham Hartzema

  5. College of Health Sciences, University of Rhode Island, Kingston, RI, USA

    Brian J. Quilliam

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Funding

Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number R15HD097588 (Principal Investigator: Dr. Xuerong Wen). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Conflicts of Interest/Competing Interests

Abraham Hartzema is the CSO of Suremed Compliance LLC and received a business grant from the NIH/NIDA (R44DA 051272-01, 08/01/2020–07/31/2023, total budget 1.6M). Kimford J. Meador has received research support from the National Institutes of Health and Sunovion Pharmaceuticals, and travel support from Eisai. The Epilepsy Study Consortium pays Kimford J. Meador’s university for his research consultant time related to Eisai, GW Pharmaceuticals, NeuroPace, Novartis, Supernus, Upsher-Smith Laboratories, and UCB Pharma. Jayne Pawasauskas is on the speakers’ bureau for Heron Therapeutics. Adam K. Lewkowitz is supported by the NICHD (K23 HD103961-A1), and his research is also supported by Essential Hospitals Institute/CVS Health Foundation and Pharmacosmos Therapeutics, Inc. Adam K. Lewkowitz was a paid speaker for Pharmacosmos as well. The other authors have no conflicts of interests that are directly relevant to the content of this article.

Ethics Approval

This study was approved and granted a waiver of informed consents by the Institutional Review Board of The University of Rhode Island (IRB 1289357-4) and Rhode Island Department of Health (IRB#: 2019-11).

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Not applicable.

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Not applicable.

Availability of Data and Material

We thank the Rhode Island Department of Health and the Executive Office of Health and Human Services for providing the data access. Restrictions apply to the availability of these data, which were used under license for this study. Data are available from the Rhode Island Department of Health upon appropriate application (https://health.ri.gov/records/).

Code Availability

The codes used in this study are available upon request.

Authors’ Contributions

SW and XW have full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: XW, SW, KJM. Acquisition, analysis, or interpretation of data: SW, XW. Drafting of the manuscript: SW, XW, KJM. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: SW. Clinical, technical, or material support: JP, AKL, KEW, TNB, AH, BJQ. Supervision: Wen, KJM. All authors read and approved the final version.

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Wang, S., Meador, K.J., Pawasauskas, J. et al. Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study. Drug Saf 46, 257–271 (2023). https://doi.org/10.1007/s40264-022-01267-z

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