Chloramphenicol and breastfeeding

Chloramphenicol is a potent broad-spectrum antibiotic

• available in the UK in several formulations-oral capsules, IV injection/infusion, ear drops, and eye drops and ointment
• associated with serious haematological side-effects when administered systemically, it is recommended that systemic use should be reserved for the treatment of life-threatening infections, particularly those caused by Haemophilus influenzae, and also for typhoid fever (1)
  • an additional concern with chloramphenicol use is "grey baby syndrome" due to toxicity in premature and young infants associated with the lack of liver enzymes to metabolize the drug

Chloramphenicol and breastfeeding (2):

• systemic chloramphenicol is normally contra-indicated in breastfeeding mothers due to the theoretical risk of aplastic anaemia, and reported adverse effects in breastfeeding infants, although the quality of this evidence is poor
  
• oral and intravenous chloramphenicol should be avoided where possible during breastfeeding
  • variable chloramphenicol levels have been found in breast milk after oral administration
    • levels have ranged from 0.3-8.5% of the weight-adjusted maternal dose
    • are no studies looking at milk levels after intravenous administration
  • oral and intravenous chloramphenicol are associated with serious haematological side-effects when administered directly, mainly with systemic use (2)
    • have also been some reports of haematological toxicity, including aplastic anaemia, after direct topical use
    • aplastic anaemia is extremely rare, and specialist opinion is that the risk is low with short courses of chloramphenicol for patients with no prior or family history of blood dyscrasias
    • although no haematological side effects have been reported in breastfed infants, they are not thought to be dose related
  • risk of grey baby syndrome
    • has occurred in premature or young infants given high doses of chloramphenicol directly, which has been fatal in some cases
    • is due to underdeveloped renal and hepatic function, which can lead to drug accumulation and toxicity
    • symptoms include grey skin colour, abdominal distension, vomiting, flaccidity and breathing difficulties
    • Grey Baby Syndrome has not been reported as a result of exposure from breastfeeding but remains a theoretical concern
      • since it is dose-related it is unlikely to occur with use during breastfeeding, especially when used topically
        • risk will also be less in older breastfed infants or children
  • side-effects reported in infants
    • one study reported several side-effects in breastfed infants following maternal exposure to oral chloramphenicol in doses ranging from 1-3g daily
    • side-effects reported were poor sucking, somnolence, vomiting, and excessive abdominal gas and distension - no other studies have reported infant side-effects from chloramphenicol exposure through breast milk
  • oral and intravenous chloramphenicol should be avoided where possible during breastfeeding due to the theoretical risk of serious infant side effects (2)
  • has been noted that (3)
    • adverse reactions such as vomiting, excessive intestinal gas and falling asleep at the breast have been reported in breastfed infants whose mothers were taking oral chloramphenicol
    • milk concentrations are not sufficient to induce "gray baby" syndrome, but since chloramphenicol-induced aplastic anaemia is not dose-related, this might occur, but has not been reported
    • an alternate drug is preferred to chloramphenicol during breastfeeding, especially while nursing a newborn or preterm infant
      
• topical chloramphenicol
  • chloramphenicol eye and ear preparations can be used with caution during breastfeeding
    • however - should not be used in mothers where there is a past or family history of blood dyscrasias
    • fusidic acid or gentamicin preparations would be preferred, if clinically appropriate
  • milk levels
    • are no data available on the levels of chloramphenicol in breast milk after topical administration of chloramphenicol whilst breastfeeding
      • based on the drug properties, and minimal absorption, levels are predicted to be very low
  • risk of haematological toxicity
    • is conflicting evidence regarding whether topical chloramphenicol can cause aplastic anaemia
      • thus is still a theoretical risk that the very low amounts of chloramphenicol which may pass into the breast milk from topical formulations could cause aplastic anaemia
  • no side-effects have been reported in breastfed infants who have been exposed to topical chloramphenicol
  • advice re: monitoring the infant if breastfeeding mother using topical chloramphenicol
    • if the mother uses topical chloramphenicol, the infant should be monitored for the following side-effects as a precautionary measure:
      • abdominal distension
      • poor feeding
      • sedation
      • difficulty breathing
      • vomiting or diarrhoea
      • anaemia
      • rash
      • ashen grey skin colour
    • this will quickly pick up any potential issues
      • usually, further investigation is required before attributing any side-effects to the medicine
    • precautionary monitoring for signs of aplastic anaemia (anaemia, rash, bruising or bleeding) should also continue for a period of time after the course has finished
  • further information
    • is no published evidence available on using topical administered chloramphenicol while breastfeeding, including the levels that might pass into breast milk
    • however, based on the drug properties and minimal systemic absorption, milk levels are predicted to be very low and unlikely to cause infant side effects (2)

Reference:

• 1. Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications (Accessed on 19 March 2019]
• 2. Specialist Pharmacy Service (May 2026).Using chloramphenicol in breastfeeding
• 3. Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Chloramphenicol. [Updated 2021 Mar 17].