This drug crosses the placental barrier. No signs of teratogenicity have been observed in rats and rabbits, but teratogenicity has been observed in mice and hamsters, possibly attributed to maternal toxicity associated with hypoxia and sedation. Like all opioid analgesics, this drug may cause respiratory depression in the neonate. Closely observe neonates whose mothers have received opioid analgesics during labor for signs of respiratory depression; an opioid antagonist, such as naloxone, should be readily available for reversal of opioid-induced respiratory depression. Neonates whose mothers have taken opioids chronically during pregnancy may exhibit neonatal withdrawal syndrome. Onset, duration, and severity of neonatal withdrawal syndrome may vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn; monitor and treat appropriately. There are no adequate and well-controlled studies in pregnant women.

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known if these effects are reversible.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk Summary: There are no available data to inform a drug-associated risk for major birth defects and miscarriage with this drug; prolonged use of opioids during pregnancy can result in physical dependence in the neonate.

Comments:
-Women using opioids during pregnancy for medical or nonmedical purposes should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
-Long-acting opioids should not be used during and immediately prior to labor, when short acting analgesics or other analgesic techniques are more appropriate.

See references

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Breastfed infants should be closely monitored; if signs of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness occur, physician should be contacted immediately.
-Maternal use of extended-release hydromorphone is not recommended during breastfeeding due to the potential for excess sedation and respiratory depression.

Maternal use of oral narcotics during breastfeeding can cause infant drowsiness, CNS depression, and even death. Newborn infants appear to be particularly sensitive to even small doses. Once a mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit hydromorphone to a few days at low doses with close infant monitoring.

In a study of single dose intranasal hydromorphone 2 mg in 8 lactating women, calculations showed an exclusively breastfed infant would receive 0.67% of the maternal weight-adjusted dose. From this same study, using average milk levels, it was calculated an exclusively breastfed infant would receive 0.15 mcg/kg daily from a single 2 mg intranasal dose (non-marketed formulation).

See references