Using chloramphenicol during breastfeeding

General considerations

It is important to complete an individual risk assessment (SPS page) for your patient and to apply the principles of prescribing in breastfeeding (SPS page) when looking at the available information and making treatment decisions.

Recommendations

Chloramphenicol eye and ear preparations can be used during breastfeeding, but infant monitoring is required. They should not be used where there is a past or family history of blood dyscrasias.

Precautions should be taken to avoid direct contact of the breastfeeding infant with the preparation, such as washing hands thoroughly after application and before touching the infant.

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

Theoretical concerns

Haematological toxicity

Chloramphenicol is associated with serious haematological side effects when administered directly, mainly with systemic use. In particular, there is an increased risk of severe aplastic anaemia, which typically develops after a latent period of weeks or even months. There 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. Therefore they could theoretically occur with any amount ingested in breast milk, including with topical use during breastfeeding.

Grey Baby Syndrome

Grey Baby Syndrome has occurred in premature or young infants given high doses of chloramphenicol directly, which has been fatal in some cases. This 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.

Specific recommendations

We provide advice for the different formulations of chloramphenicol.

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. Get in touch with the UK Drugs In Lactation Advisory Service (UKDILAS) (SPS page), our specialist breastfeeding medicines advice service, if you need support in the following situations:

• the infant is unwell or born premature
• multiple medicines are being taken
• if oral or intravenous chloramphenicol is required

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