chloramphenicol and breastfeeding

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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

  • although there are concerns around "grey baby syndrome" and chloramphenicol use, milk concentrations as a result of systemic exposure are likely to be too low to cause this effect. It is therefore extremely unlikely with ophthalmic and ear preparations

  • ophthalmic chloramphenicol products are routinely used, and considered to be the treatment of choice for superficial eye infections, including in children

  • there is no evidence on the safety of topical chloramphenicol in infants exposed via breastfeeding after maternal use; risks of toxicity in the infant are theoretical and not supported by direct clinical evidence. Therefore, the use of chloramphenicol via the ear or eye can proceed with caution

  • if microbiologically appropriate, preparations containing fusidic acid or gentamicin are preferred

  • topical chloramphenicol should be avoided during breastfeeding if there is a past or family history of blood dyscrasias

  • if chloramphenicol eye drops are considered appropriate during breastfeeding, systemic absorption can be minimised by naso-lachrymal occlusion immediately after administration

  • as a precaution monitor the infant for abdominal distension, difficulty breathing, vomiting, diarrhoea, anaemia, rash, and ashen grey skin colour, following maternal exposure to chloramphenicol via any route

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 (March 2019).Chloramphenicol: is it safe in breastfeeding?

Last edited 03/2019 and last reviewed 07/2021

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