Skip to Main Content
The first stop for professional medicines advice

Using chloramphenicol during breastfeeding

Published Last updated See all updates
Topics: ChloramphenicolEyes and visionInfection and infectious diseasesSafety in Breastfeeding

Topical chloramphenicol can be used with caution and monitoring. Systemic chloramphenicol is not recommended. Advice applies to full term and healthy infants.

Contents

  1. General considerations
  2. Recommendations
  3. Theoretical concerns
    1. Haematological toxicity
    2. Grey Baby Syndrome
  5. Specific recommendations
    1. Topical chloramphenicol
    2. Oral and intravenous chloramphenicol
  7. Patient information
  8. Further advice
  9. Update history

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. The risk will also be less in older breastfed infants or children. 

Specific recommendations

We provide advice for the different formulations of chloramphenicol.

Use with caution

Chloramphenicol eye and ear preparations can be used with caution during breastfeeding. Short courses are preferred where possible. However, they should not be used where there is a past or family history of blood dyscrasias.

Fusidic acid or gentamicin preparations would be preferred, if clinically appropriate.

Infant monitoring

Although side effects are unlikely, as a precaution, monitor the infant for:

  • abdominal distension
  • poor feeding
  • sedation
  • vomiting or diarrhoea
  • anaemia (pallor, lethargy)
  • rash
  • unusual bruising or bleeding

Monitoring the infant will quickly pick up any potential issues, but usually further investigation is required before the cause can be identified. The risk of side effects will be lower in older infants and children, however they should still be monitored as above.

If a side effect is suspected, contact a healthcare professional for further advice.

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

There 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.

Not recommended

Oral and intravenous chloramphenicol should be avoided where possible during breastfeeding due to the theoretical risk of serious infant side effects. Contact our specialist service (SPS page) for further advice.

Further information

Variable but small chloramphenicol levels have been found in breast milk after oral administration. Levels have ranged from 1 to 8.5% of the weight-adjusted maternal dose. Infant serum levels have not been measured. There are no studies looking at milk levels after intravenous administration.

One study reported several side-effects in breastfed infants following maternal exposure to oral chloramphenicol in doses ranging from 1 to 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.

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

Update history

  1. Clarified that the risk of side effects, including Grey baby syndrome, is less in older breastfed infants and children
  1. Republished
  2. Full clinical review and update
  1. Minor title amendment
  1. Published