Can I take codeine while pregnant or breastfeeding?

8.1 Pregnancy R i sk Summary: Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4 )] . Available data with codeine sulfate tablets are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, codeine administration during organogenesis has been shown to produce delayed ossification in the offspring of mice at 1.4 times maximum recommended human dose (MRHD) of 360 mg/day, embryolethal and fetotoxic effects in the offspring of rats and hamsters at approximately 2 to 3 times the MRHD, and cranial malformations/cranioschisis in the offspring of hamsters between 2 and 8 times the MRHD [s ee D ata ] . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Codeine Sulfate (oral), Lannett Company, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Numerous professional organizations and regulatory agencies recommend that other agents are preferred over codeine or to avoid codeine completely during breastfeeding;[1-5] however, these recommendations appear to be based on one case report that has since been discredited, and large population studies have not found codeine to be more dangerous than other opioids that have been studied less and may not be safer.[6-8] Maternal use of any oral opioid in high dosages during breastfeeding can cause infant drowsiness, which can progress to more severe central nervous system depression.[9,10] Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. If the mother of a newborn requires codeine, it is not a reason to discontinue breastfeeding; however, once the mother’s milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of oral codeine to 2 to 3 days at a low dosage with close infant monitoring, especially in the outpatient setting.[10-14] If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.[15] Excessive sedation in the mother often correlates with excess sedation in the breastfed infant. Following these precautions can lower the risk of neonatal sedation.[16] Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.

“Summary of Use during Lactation”, LactMed record “Codeine” (LM347), quoted verbatim. Everything LactMed reports about Codeine while breastfeeding.

8.2 Lactation R i sk Summary: Codeine and its active metabolite, morphine, are present in human milk. There are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk. Women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. There is no information on the effects of codeine on milk production. Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with codeine sulfate tablets [see Warnings and Precautions ( 5.4 )] . C lin i cal Considerations: If infants are exposed to codeine sulfate tablets through breast milk, they should be monitored for excess sedation and respiratory depression.

Prescribing label, section “8.2 Lactation” (opening excerpt): Codeine Sulfate (oral), Lannett Company, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.