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Codeine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brand names: Codar D, Cycofed, EndaCof-DC, KG-Fed, Notuss-DC, Nucodine, Nucofed

Codeine / pseudoephedrine Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not formally assigned a pregnancy category

-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.
-Pseudoephedrine should be avoided during the first trimester.

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.

In rabbits and rats, pseudoephedrine in doses of 35 and 50 times the human daily dose, respectively, have not produced teratogenic effects. Limited data in human pregnancy has shown an elevated risk of gastroschisis (defective closure of the abdominal wall) with first-trimester use; vascular disruption has been postulated as the etiology. There are no adequate and well controlled studies in pregnant women.

See references

Codeine / pseudoephedrine Breastfeeding Warnings

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.

Pseudoephedrine may occasionally cause irritability in a nursing infant. A single dose has been shown to decrease milk production acutely while repeated use seems to interfere with lactation. This drug has been used to decrease milk supply. Mothers whose lactation is not established and mothers who are having difficulties producing sufficient milk should not take pseudoephedrine.

Use is not recommended

Excreted into human milk: Yes (codeine); Yes (pseudoephedrine)

Comments: Breastfeeding is not recommended when taking codeine due to the risk of serious adverse reactions in breastfed infants.

See references

References for pregnancy information

  1. Smith CV, Rayburn WF, Anderson JC, Duckworth AF, Appel LL. Effect of a single dose of oral pseudoephedrine on uterine and fetal Doppler blood flow. Obstet Gynecol. 1990;76:803-6.
  2. Heinonen O, Shapiro S; Kaufman DW ed., Slone D. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, Inc. 1977;297.
  3. Werler MM, Mitchell AA, Shapiro S. First trimester maternal medication use in relation to gastroschisis. Teratology. 1992;45:361-7.
  4. Cerner Multum, Inc. UK Summary of Product Characteristics.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  2. Seymour S. Joint Pulmonary-Allergy Drugs and Drug Safety and Risk Management Advisory Committee Meeting, FDA Introductory Remarks. 2016.
  3. 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. 2017.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.