Can I take co-codamol while pregnant or breastfeeding?

Pregnancy Teratogenic Effects Codeine A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg subcutaneous dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no adequate and well-controlled studies in pregnant women. Acetaminophen and codeine phosphate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea and failure to gain weight.

Prescribing label, section “Pregnancy” (opening excerpt): ACETAMINOPHEN AND CODEINE PHOSPHATE (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Acetaminophen is a good choice for analgesia, and fever reduction in nursing mothers. Giving acetaminophen and ibuprofen on a fixed schedule for 24 hours after vaginal delivery appears to increase the breastfeeding rate. There is no difference in breastfeeding initiation rate between ibuprofen or acetaminophen alone after vaginal delivery. Amounts in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare.

“Summary of Use during Lactation”, LactMed record “Acetaminophen” (LM330), quoted verbatim. Everything LactMed reports about Acetaminophen while breastfeeding.

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.

Nursing Mothers 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 acetaminophen and codeine phosphate tablets ( see WARNINGS ). Acetaminophen is excreted in breast milk in small amounts, but the significance of its effect on nursing infants is not known.

Prescribing label, section “Nursing Mothers” (opening excerpt): ACETAMINOPHEN AND CODEINE PHOSPHATE (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.