Oral and Intravenous Chloramphenicol

Recommendation

Oral and intravenous chloramphenicol should be avoided where possible during breastfeeding.

Milk levels

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. There are no studies looking at milk levels after intravenous administration.

Haematological toxicity

Oral and intravenous chloramphenicol are associated with serious haematological side-effects when administered directly. Although 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.

Grey Baby Syndrome

An additional concern with chloramphenicol use is 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. However, this has not been reported as a result of exposure from breastfeeding.

Infant side-effects

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

Recommendation

Chloramphenicol eye and ear preparations can be used with caution during breastfeeding. However, they should not be used in individuals where there is a past or family history of blood dyscrasias.  Fusidic acid or gentamicin preparations would be preferred, if clinically appropriate.

Milk levels

There 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.

Haematological toxicity

There is conflicting evidence regarding whether topical chloramphenicol can cause aplastic anaemia. Therefore there 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.

Infant side-effects

No side-effects have been reported in breastfed infants who have been exposed to topical chloramphenicol.

Monitoring the infant

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.

Patient information

Patient information is available regarding the use of topical chloramphenicol, including use in breastfeeding, on the NHS website.

Further advice

Recommendations apply to full-term and healthy infants. If the infant was born prematurely or unwell, or if multiple medicines are being taken, or if oral or intravenous chloramphenicol is required, contact the UK Drugs in Lactation Advisory Service.

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