Buprenorphine-naloxone Does Not Result in an Increased Incidence of Neonatal Opioid Withdrawal Syndrome Compared With Buprenorphine Alone
The standard of care for treating pregnant women with opioid use disorder (OUD) is opioid agonist treatment. The MOTHER study (2010) showed that buprenorphine was non-inferior—and for some outcomes superior—to methadone for the treatment of OUD in pregnancy, but it has long been thought that combination buprenorphine-naloxone (in contrast with buprenorphine alone) was not to be used in pregnant patients. This retrospective cohort study compared maternal and neonatal outcomes among pregnant women with OUD treated in a comprehensive perinatal program with buprenorphine alone (n=108) or the buprenorphine-naloxone combination (n=85). The primary outcome was incidence of neonatal abstinence syndrome (now referred to as neonatal opioid withdrawal syndrome).
- The rate of neonatal abstinence syndrome was significantly higher among infants exposed in utero to buprenorphine (55%) versus buprenorphine-naloxone (35%).
- Combination buprenorphine-naloxone was associated with a reduced odds of neonatal abstinence syndrome (odds ratio, 0.45). However, after adjusting for clinical factors this association was no longer present.
Comments: This single-site retrospective cohort study of pregnant women with opioid use disorder suggests that buprenorphine-naloxone may be appropriate for treatment of OUD in this population. Larger, controlled trials should be performed to confirm these findings.
Jeanette M. Tetrault, MD
Reference: Mullins N, et al. Buprenorphine and naloxone versus buprenorphine for opioid use disorder in pregnancy: a cohort study. J Addict Med. 2019 [Epub ahead of print]. doi: 10.1097/ADM.0000000000000562.
2 comments
Only one death with Buprenorphine used alone, including IV abuse in 20 years and millions of doses (Invidior). Combination product causes 33+% drug sensitivities and intolerance. Much less with monoproduct. When developed, OD a concern, but not now. Forcing patients to use a product that has such a high intolerance and side effect profile inappropriate in light of now proved 20 yr safety with OD. Proving that it can be used in pregnancy and forcing use there is not appropriate in light of safety profile and causes illness and harm to patients. Something we should not be requiring considering the proved safety and much better tolerance of the monoproduct. Not to mention that it is much less expensive to produce the monoproduct.
We would like to thank Dr. Rust for his insightful comment. In our clinical experiences, the AOD Health Associate Editors have seen few cases of intolerance to either the combination buprenorphine/naloxone or the buprenorphine monoproduct. Additionally, we have seen marked improvement in pricing profiles as more formulations have generic equivalents. With increasing literature supporting the use of mono and combination products in different clinical settings, we urge our readership to use evidence-based strategies for patient-centered treatment planning. We appreciate and encourage discussion regarding the papers highlighted in AOD Health!