Buprenorphine + naloxone in the treatment of opioid dependence during pregnancy-initial patient care and outcome data.

BACKGROUND AND OBJECTIVES: Research has indicated that the buprenorphine-mono product yields maternal outcomes similar to methadone and a less severe neonatal abstinence syndrome. However, maternal and neonatal outcomes following buprenorphine + naloxone exposure during pregnancy have not been documented.

METHODS: Retrospective chart review identified 10 opioid-dependent pregnant women treated with the buprenorphine + naloxone film product between January, 2010-June, 2011. Seven maternal outcome measures - weight gain, fetal presentation at delivery, Cesarean delivery, analgesia during delivery, urine drug screening results at delivery, number of days of maternal hospital stay, and began breastfeeding following delivery-and eleven neonatal outcome measures-gestational age at delivery, 1- and 5-minute Apgar scores, head circumference, length, and weight at birth, treated for neonatal abstinence syndrome (NAS), total amount of morphine sulfate needed to treat NAS, length of hospital stay for NAS treatment, and length of hospital stay-were extracted from medical records.

RESULTS: Maternal findings were unremarkable, and comparable with what might be found following treatment with the buprenorphine-mono product. Neonates were full-term with normal birth parameters. Four neonates were treated for NAS, and number of days treated for NAS and number of hospital days were in line with values reported for the buprenorphine-mono product.

CONCLUSIONS: Findings suggest no obvious significant adverse maternal or neonatal outcomes related to the use of buprenorphine + naloxone for the treatment of opioid dependence during pregnancy.

SCIENTIFIC SIGNIFICANCE: These initial findings underscore the need for future research to systematically examine the relative safety and effectiveness of buprenorphine + naloxone for mother, fetus, and child.