9 July 2021

MHRA releases review findings into use of chloramphenicol

MHRA agrees with the College view that chloramphenicol eye drops can be safely administered to children aged 0 to 2 years, where antibiotic eye drop treatment is indicated.

Following the College’s statement on the use of chloramphenicol in paediatric populations, we asked the Medicines and Healthcare products Regulatory Agency (MHRA) to review the current conflicting advice. The MHRA review agrees with the College view that chloramphenicol eye drops can be safely administered to children aged 0 to 2 years, where antibiotic eye drop treatment is indicated.     

Their review concluded that:  

  • The benefits of chloramphenicol eye drops containing borax or boric acid outweigh the potential risks for children, including those aged 0 to 2 years.
  • A typical regimen of one drop, applied typically 3 to 4 times a day, to both eyes, would result in a daily exposure well below the safety limit for children aged 0 to 2 years.
  • Chloramphenicol eye drops remain an important medicine for children when antibiotic eye treatment is indicated and that they have been used safely for many years.

Dr. Paramdeep Bilkhu MCOptom, Clinical Adviser at The College of Optometrists, said: “We’re happy to see that the MHRA agrees with our recommendations, and that of other professional bodies. Optometrists should consider prescribing chloramphenicol POM eye drops for use in children under 2 years if they believe the benefits outweigh any possible risks.”

The product information for affected chloramphenicol products is being updated to reflect the revised advice and remove restrictions for use in infants.   

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