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Buprenorphine / naloxone Pregnancy and Breastfeeding Warnings

Buprenorphine / naloxone is also known as: Suboxone

Overview

Buprenorphine/Naloxone may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Buprenorphine/Naloxone while you are pregnant. Buprenorphine/Naloxone is found in breast milk. Do not breast-feed while taking Buprenorphine/Naloxone.

Buprenorphine / naloxone Pregnancy Warnings

Buprenorphine has been assigned to pregnancy category C by the FDA. Post-implantation losses, acephalus, and omphacele have been reported with high doses in animal studies. High doses have also been associated with statistically nonsignificant skeletal abnormalities in animal studies. Dystocia has been reported in pregnant rats. There are no controlled data in human pregnancy. Buprenorphine use during pregnancy has been associated with neonatal withdrawal symptoms. Buprenorphine-naloxone should only be used during pregnancy if the potential benefit justifies the risk to the fetus.

Buprenorphine / naloxone Breastfeeding Warnings

Buprenorphine is excreted into human milk. Extradural buprenorphine was associated with decreased milk production and infant weight gain in a clinical trial (n=20). In animal studies, a lack of milk production was observed. The manufacturer recommends against breast-feeding during buprenorphine-naloxone therapy.

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