Benefit should outweigh risk

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

Risk Summary: Available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; prolonged use during pregnancy may cause neonatal opioid withdrawal syndrome.

Comments:
-Neonates exposed to opioid analgesics during labor should be monitored for signs of excess sedation and respiratory depression.
-Prolonged maternal use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Reduced fetal rat body weight and pup weights have been reported at 2.2 times the human doses; no malformations were observed with bolus injections to pregnant rats or rabbits during organogenesis at doses up to 5 times human doses. This drug rapidly crosses the placenta and may produce respiratory depression in the neonate; IV use is generally not recommended during or immediately prior to labor when other analgesic techniques are more appropriate. As with other narcotics, opioid effects can be quickly reversed with naloxone. There are no adequate and well controlled studies in pregnant women.

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.

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Because the half-life of this drug is very short, adverse effects in the breastfed infant are unlikely; however, limited information is available on its use during breastfeeding. No signs of sedation were observed breastfed infants in one small study (n=4) in which breastfeeding mothers received this drug (in addition to propofol, rocuronium, and inhaled xenon) as part of general anesthesia (drug levels targeted at 4.5 mcg/L during the procedure and 1.5 mcg/L at the end of anesthesia). Infants were nurse at 1.5. 2.8, 4.6, and 5 hours after extubation.

Use with caution

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Breastfed infants should be monitored for excess sedation and respiratory depression.
-Mothers who breastfeed should consider waiting 24 hours after receiving this drug before breastfeeding.
-When maternal administration of an opioid analgesic is stopped or breastfeeding is stopped, withdrawal symptoms can occur in breastfed infants.

See references