Numerics

Change in advice on using POM Chloramphenicol 0.5% eye drops in children aged 0 to 2 years

The Medicines and Healthcare products Regulatory Agency (MHRA) has conducted a review of the interpretation of the EU guidance on boric acid safety in children aged 0 to 2 years. They reviewed the available evidence and sought independent expert advice from the Commission on Human Medicines to understand the risk to infants when chloramphenicol eye drops 0.5% are used within the licensed indication for what is likely to be a short period of time.

It has been concluded that the benefit-risk balance of chloramphenicol eye drops containing boron or boric acid remains positive for children aged 0 to 2 years and as such the MHRA has requested the removal of restrictions and associated warning about boron exposure in children aged 0 to 2 years from all SPCs and PILs for UK chloramphenicol eye drops products.

Advice for Community Pharmacy Teams

  • Advise parents and caregivers that chloramphenicol eye drops remain an important antibiotic eye treatment for children and have been used safely for many years
  • Until new patient information leaflets (PILs) are available reassure concerned parents and caregivers that chloramphenicol eye drops can be used safely when prescribed for use in their children as long as the instructions for use are followed

More information here