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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 51-21-8
Drug Levels and Effects
Summary of Use during Lactation
Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy.[1] It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence. The duration of abstinence is not clear, but some have suggested a period of 24 hours before resuming nursing, while others have used a 72-hour abstinence period safely.[2,3] Limited information indicates that a maternal continuous intravenous fluorouracil infusion at a dose of 200 mg/square meter daily produces undetectable levels in milk. If fluorouracil use is undertaken, monitoring of the infant's complete blood count and differential is advisable. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.[4] Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.[5]
Topical fluorouracil applied away from the breast should pose negligible risk for the breastfed infant. If the mother requires topical fluorouracil, it is not a reason to discontinue breastfeeding. Do not apply fluorouracil to the breast or nipple and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated
Drug Levels
Maternal Levels. A mother who was 9 months postpartum was diagnosed with rectal cancer and began treatment with pelvic radiotherapy and a continuous intravenous infusion of fluorouracil 200 mg/square meter daily. Her plasma fluorouracil concentration was constant at about 110 micromoles/L (14.3 mg/L) from weeks 2 to 5 of therapy. She discontinued nursing her infant and pumped her breasts twice daily and collected 36 breastmilk samples before, during and for 10 days following fluorouracil therapy (exact times not specified). Fluorouracil was undetectable (<0.5 micromole/L [<65 mcg/L]) in all of the milk samples.[6]
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
A woman was diagnosed with colorectal cancer at 26 weeks of gestation. She was treated with unspecified doses of fluorouracil, oxaliplatin, and calcium folinate (leucovorin calcium) at 28 weeks in the first of 3 planned doses. However, the infant was born at 30 weeks gestation, 14 days after the first dose. On day 1 postpartum, the infant was given colostrum mouth care and the mother’s milk supply was initiated. On days 8 and 22 postpartum, the infusions of fluorouracil were given, without oxaliplatin. Pumped breastmilk was fed to the infant except for the 48 hours of fluorouracil infusion and for the 24 hours afterward. The infant was exclusively breastfed on discharged from the NICU on day 50 and at 11 months postpartum, the infant was thriving.[3]
Effects on Lactation and Breastmilk
A telephone follow-up study was conducted on 74 women who received cancer chemotherapy at one center during the second or third trimester of pregnancy to determine if they were successful at breastfeeding postpartum. Only 34% of the women were able to exclusively breastfeed their infants, and 66% of the women reported experiencing breastfeeding difficulties. This was in comparison to a 91% breastfeeding success rate in 22 other mothers diagnosed during pregnancy, but not treated with chemotherapy. Other statistically significant correlations included: 1. mothers with breastfeeding difficulties had an average of 5.5 cycles of chemotherapy compared with 3.8 cycles among mothers who had no difficulties; and 2. mothers with breastfeeding difficulties received their first cycle of chemotherapy on average 3.4 weeks earlier in pregnancy. Of the 9 women who received a fluorouracil-containing regimen, 8 had breastfeeding difficulties.[5]
References
- 1.
- Pistilli B, Bellettini G, Giovannetti E, et al. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: How should we counsel cancer patients about breastfeeding? Cancer Treat Rev 2013;39:207–11. [PubMed: 23199900]
- 2.
- Johnson HM, Mitchell KB. ABM clinical protocol #34: Breast cancer and breastfeeding. Breastfeed Med 2020;15:429–34. [PubMed: 32516007]
- 3.
- Wilson G, Calder A, Allermo Fletcher A. Exclusive breastfeeding of a premature infant following maternal administration of chemotherapy for bowel cancer: A case study. J Hum Lact 2026:8903344261419357. [PubMed: 41866778]
- 4.
- Urbaniak C, McMillan A, Angelini M, et al. Effect of chemotherapy on the microbiota and metabolome of human milk, a case report. Microbiome 2014;2:24. [PMC free article: PMC4109383] [PubMed: 25061513]
- 5.
- Stopenski S, Aslam A, Zhang X, et al. After chemotherapy treatment for maternal cancer during pregnancy, is breastfeeding possible? Breastfeed Med 2017;12:91–7. [PubMed: 28170295]
- 6.
- Peccatori FA, Giovannetti E, Pistilli B, et al. "The only thing I know is that I know nothing": 5-fluorouracil in human milk. Ann Oncol 2012;23:543–4. [PubMed: 22275286]
Substance Identification
Substance Name
Fluorouracil
CAS Registry Number
51-21-8
Drug Class
Breast Feeding
Milk, Human
Antimetabolites
Antineoplastic Agents
Antimetabolites, Antineoplastic
Immunosuppressive Agents
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