Chloramphenicol Eye Drops & Boron – RCOphth Safety Alert

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The Royal College of Ophthalmologists have published a statement on the recent regulatory changes affecting use of chloramphenical eye drops for young children @

Boron additives in Chloramphenicol drops safety alert – Summary

All prescribing decisions involve an equation of benefit versus risk. Chloramphenicol has been an effective and well-tolerated antibiotic in ophthalmological practice for nearly 70 years. Whilst a theoretical risk to future fertility from boron-containing excipients in chloramphenicol eyedrops should not be dismissed lightly, a decision to stop using chloramphenicol eyedrops in children also carries risks for the reasons given above.

Although more data on the concentration of borates in individual formulations of chloramphenicol are required, currently available data suggest that the recommended maximum daily dose of boron is unlikely to be exceeded with conventional eyedrop regimes, even for children under the age of two. At the present time, the College believes that the benefits of chloramphenicol eyedrops in paediatric ophthalmic practice for appropriate indications and with courses of appropriate duration outweigh the possible risks posed by boron ingestion.

The RCOphth is seeking to work with the MHRA and the DHSC Senior Pharmacist Medicine Supply Team on this issue to ensure the advice given by all national bodies and suppliers is proportionate and supports clinical requirements.

It may be helpful to remember RCGP advice that

  • Topical antibiotics should not be routinely prescribed unless special circumstances require shorter symptom duration
  • Education of patient, family and school is important to reduce expectation of antibiotic drops