A Comparison of Buprenorphine + Naloxone to Buprenorphine and Methadone in the Treatment of Opioid Dependence during Pregnancy: Maternal and Neonatal Outcomes

Abstract

Given that buprenorphine + naloxone is prescribed for opioid-dependent pregnant women, it is important to examine the extent to which it differs from buprenorphine alone, methadone, or methadone-assisted withdrawal on neonatal and maternal outcomes. Summary statistics on maternal and neonatal outcomes were collected from 7 previously published studies examining treatment for opioid-dependent pregnant women that represented a range of research methodologies. Outcomes from these studies were compared to the same outcomes for 10 women treated with the combined buprenorphine + naloxone product. There were no significant differences in maternal outcomes for buprenorphine + naloxone compared to buprenorphine, methadone, or methadone-assisted withdrawal. Preliminary findings suggest no significant adverse maternal or neonatal outcomes related to the use of buprenorphine + naloxone for the treatment of opioid dependence during pregnancy. However, further research should examine possible differences between buprenorphine + naloxone and buprenorphine alone or methadone in fetal physical development.

129: Neonatal outcomes following in utero exposure to buprenorphine/naloxone or methadone

“…Like others, we believe the combination product offers multiple advantages, namely, the presence of the mu-opioid antagonist naloxone, which limits abuse potential. 12,16,17 If taken parenterally, naloxone induces rapid withdrawal; however, if taken sublingually, naloxone has poor bioavailability. 25 Therefore, this combination product should not cause additional concerns during pregnancy compared to single-entity buprenorphine.…”

“…Unfortunately, there is limited data on the use of this medication during pregnancy and its effect on the neonate. 16,17 …”

Buprenorphine with, or without, Naloxone for Pregnant Women?–Review of Current Evidence and Practice in Massachusetts

“…Importantly, buprenorphine's ceiling effect decreases the risk of overdose [8,12,13]. Buprenorphine has been associated with improved outcomes in fetal growth, while causing less neonatal abstinence syndrome when compared to methadone [20][21][22][23]. In 2012, a randomized clinical trial, observed better surrogate measures of fetal well-being via non-stress test and biophysical profile post-dosing of buprenorphine versus methadone [24].…”

“…Limited but growing amounts of data show relative safety of this combination directly in pregnant women [22,23]. Pharmacokinetic studies reporting on absorption of sublingual naloxone from the co-formulated products demonstrate that at commonly prescribed doses, the levels of naloxone remain insignificant [38].…”

Opioid use in pregnancy and parenting: An Indigenous-based, collaborative framework for Northwestern Ontario

“…• Community-based, low dose buprenorphine + naloxone treatment became more widely available on rural and remote First Nations in Northwestern Ontario since 2012 • Although no harm has been shown in case reports of buprenorphine + naloxone in pregnancy, robust evidence is not yet available to support its use [13][14][15][16] • Guidelines recommend that women who are stable on buprenorphine + naloxone should be counseled to switch to the buprenorphine monoproduct that has been shown to be a safe and effective treatment for opioid dependence in pregnancy 17 • Buprenorphine is only available through a Health Canada special access program • In Northwestern Ontario, many women elect to remain on buprenorphine + naloxone and, in our region, the maternal and neonatal outcomes of this group are similar to women with no opioid exposure in pregnancy 9 How is neonatal abstinence syndrome managed in the region?…”