Benefit should outweigh risk

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.

Embryolethality and maternal toxicity were observed in rats given IV doses of 0.9 times the human procedural dose during organogenesis. 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. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome. Epidural use during labor and delivery has been used; although high doses should be avoided because of potential risks to the newborn infant after delivery. As with other narcotics, opioid effects can be quickly reversed with naloxone. There are no adequate and well controlled studies in pregnant women.

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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Epidural use during labor or for a short-time immediately postpartum is not expected to cause adverse effects in breastfed infants. Use may delay onset of lactation, however with good breastfeeding support, epidural use is expected to have little to no effect on breastfeeding success. There is no data on IV use during established lactation or sublingual use; other agents may be preferred.

Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Developmental and health benefits of breastfeeding should be considered along with mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.
-Breastfed infants should be monitored for excess sedation and respiratory depression; immediate medical attention should be sought if the infant shows signs of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness.

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