Benefit should outweigh risk

US FDA pregnancy category: Not Assigned

Risk Summary: Available human pregnancy data is insufficient to inform a drug-associated risk for major birth defects and miscarriage; animal reproduction studies have shown an almost 50% embryo lethality at doses 12 times the human daily dose.

Comments:
-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.

Mice receiving oral levorphanol at 10 and 12 times the human daily dose (12 mg/day) showed malformations and nearly 50% embryo lethality, respectively. At doses of 34 times the human daily dose, paternal exposure to levorphanol prior to mating resulted in reduced litter birth weights, developmental delays, and aberrant behavior in a swim maze. Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no controlled data in human pregnancy.

Chronic opioid use may cause reduced fertility in males and females; it is unknown whether these effects on fertility are reversible.

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.

See references

There is no data on excretion of this drug into breastmilk. Morphine, a drug which is structurally similar, is excreted into human milk.

A decision should be made to discontinue nursing or discontinue this drug, taking into account the importance of the drug to the mother

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: Monitor closely for excess sedation and respiratory depression; withdrawal effects can occur in breastfed infant if maternal administration is stopped or breastfeeding is stopped.

See references