Buprenorphine/Naloxone Film 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 Film while you are pregnant. Buprenorphine/Naloxone Film is found in breast milk. Do not breast-feed while taking Buprenorphine/Naloxone Film.
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.
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