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
    • such adverse effects have not been reported in breastfed infants, they represent significant risk
      • in particular, there is an increased risk of aplastic anaemia
      • this effect is not thought to be dose-related, and therefore might occur as a result of exposure via breastfeeding
  • risk of grey baby syndrome
    • chloramphenicol can cause toxicity in some premature and young infants because their underdeveloped liver enzymes are unable to metabolise (break down) the drug properly
    • symptoms of Grey Baby Syndrome include grey skin colour, abdominal distention, vomiting, flaccidity and breathing difficulties - note that this has not been reported as a result of exposure from breastfeeding
  • 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
• 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

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 (June 2022).Using chloramphenicol in breastfeeding