Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: Based on animal data, may cause fetal harm; prolonged maternal use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome.

Comments:
-Women 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.

Rats administered this drug during gestation and lactation showed increases in stillborn pups and decreases in pup survival at doses equivalent to the human dose of 100 mg/day. Reduced nursing behavior and decreased body weights were observed at 2 times the human dose. Reduced fetal weights were observed in rabbits given this drug during the period of organogenesis at doses equivalent to 5 times the human dose of 100 mg/day. Additionally, increases in the number of umbilical hernias, irregularly shaped bones, and delays in fetal skeletal maturation were observed in the study at doses 15 times the human dose of 100 mg/day. No fetal malformations were observed in rats and rabbits at doses approximately 2 (rats) and 10 (rabbits) times a human dose of 100 mg/day. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes 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.

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Maternal use of oral narcotics during breastfeeding can cause infant drowsiness, central nervous system depression, and even death. Newborns are particularly sensitive. Once a mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic. There are no studies describing drug levels of extended-release hydrocodone or its metabolites in breast milk. Hydrocodone is metabolized to 6 active metabolites including hydromorphone.

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments: Infants exposed to this drug through breast milk should be closely monitored for excess sedation and respiratory depression; withdrawal symptoms can occur when maternal administration of hydrocodone is stopped or breastfeeding is stopped.

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