Buprenorphine / naloxone Pregnancy and Breastfeeding Warnings
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.
- buprenorphine/naloxone Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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