Nalbuphine Pregnancy Warnings
The placental transfer of nalbuphine is high, rapid, and variable with a maternal to fetal ratio ranging from 1:0.37 to 1:6. Fetal and neonatal adverse effects reported following the administration to the mother during labor include fetal bradycardia, respiratory depression, apnea, cyanosis, and hypotonia. Severe and prolonged fetal bradycardia including a case of permanent neurological damage attributed to fetal bradycardia and a case of sinusoidal fetal heart rate pattern have been reported. Maternal administration of naloxone during labor may normalize these events. This drug may not be appropriate for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. In the postmarketing period, fetal death has been reported where mothers received this drug during labor and delivery. There are no controlled data in human pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Benefit should outweigh risk
US FDA pregnancy category: Not assigned
Risk Summary: Available data in pregnant women is insufficient to inform a drug-associated risk for major birth defects and miscarriage.
Comments:
-If used anytime during pregnancy, appropriate measures to detect and manage fetal bradycardia should be available.
-If used during labor and delivery, monitor newborn for respiratory depression, apnea, bradycardia, and arrhythmias.
-Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
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