Codeine / phenylephrine Pregnancy and Breastfeeding Warnings
Codeine / phenylephrine is also known as: Ala-Hist AC, Notuss-PE
Codeine / phenylephrine Pregnancy Warnings
In rats, codeine has been shown to be embryolethal and fetotoxic at maternally toxic doses. In rats and rabbits administered doses ranging from 5 to 120 mg/kg during the period of organogenesis, teratogenicity was not observed. Prolonged use of opioids during pregnancy has resulted in babies being born physically dependent. Opioids administered to mothers shortly before delivery may result in some degree of newborn respiratory depression, especially with higher doses. Limited data is available on the oral use of phenylephrine in pregnancy. There are no adequate and well-controlled studies in pregnant women.
Benefit should outweigh risk
-Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
Codeine / phenylephrine Breastfeeding Warnings
Use is not recommended
Excreted into human milk: Yes (codeine); Yes (phenylephrine)
Comments: Breastfeeding is not recommended when taking codeine due to the risk of serious adverse reactions in breastfed infants.
The US FDA recommends against use of prescription codeine pain and cough medicines in breastfeeding women. This is due to serious reactions in breastfed infants including excess sleepiness, difficultly breastfeeding, or serious breathing problems that could result in death. The US FDA is considering regulatory action for OTC combination cough and cold products containing codeine
Codeine is present in breast milk and for women with normal codeine metabolism (normal CYP450 2D6 activity). The amount of codeine secreted is low and dose-dependent; however, in women who are ultra-rapid metabolizers of codeine (those with a specific CYP450 2D6 genotype) higher-than-expected serum levels of morphine (codeine's active metabolite) may be present in breast milk which may lead to dangerously high serum morphine levels in breastfed infants. In most cases, a person's specific CYP450 2D6 genotype is unknown. Several small series and 1 small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia, and cyanosis in the first week of life. A death of a breastfeed infant due to respiratory depression has been reported; the mother was found to be a CYP450 2D6 ultrarapid metabolizer.
References for pregnancy information
- "Product Information. Codeine Sulfate (codeine)." Roxane Laboratories Inc, Columbus, OH.
References for breastfeeding information
- US Food and Drug Administration (FDA) "FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm549679.h" ([2017, Apr 20]):
- Seymour S "Joint Pulmonary-Allergy Drugs and Drug Safety and Risk Management Advisory Committee Meeting, FDA Introductory Remarks. Available from: URL: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/pulmonary-allergydrugsadvisorycom" ([2015, Dec 10]):
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.