Suitability for use

The MHRA has concluded that chloramphenicol eye drops can be safely administered to children aged 0 to 2. This advice supersedes regulatory advice from the European Medicines Agency (EMA) and a safety alert published by the Royal College of Ophthalmologists.

Advice from the MHRA

The MHRA have published guidance on chloramphenicol eye drops containing borax or boric acid buffers: use in children younger than 2 years. Following a review of the available toxicological data and a calculation of daily exposure to boron from a typical dosing regimen, the MHRA has concluded that the balance between the benefits and risks of chloramphenicol eye drops containing borax or boric acid remains positive for children aged 0 to 2 years. Chloramphenicol eye drops can be safely administered to children aged 0 to 2 years where antibiotic eye drop treatment is indicated.

Advice for healthcare professionals:

• some licences for chloramphenicol eye drop products containing borax or boric acid buffers were recently updated to restrict use in children younger than 2 years of age to reflect warnings on maximum daily limits for boron exposure
• we have reviewed the available evidence and sought independent expert advice to understand whether there is a risk for children aged 0 to 2 years when using these products within the licensed indication, for what is likely to be a short period of time
• our review has 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
• advise parents and caregivers that 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 – see Advice to provide to parents and carers below
• the product information for affected chloramphenicol products is being updated to reflect the revised advice and remove restrictions for use in infants – in the meantime we ask healthcare professionals to reassure parents and carers that these products can be safely given to children aged 0 to 2 years as prescribed

Advice for healthcare professionals to provide to parents and carers

• eye infections (conjunctivitis) are very common in babies and infants and it is important they are treated properly
• chloramphenicol eye drops are an important medicine for treating bacterial eye infections in children and have been used safely for many years
• some eye drops contain borax or boric acid, which are sources of boron – these ingredients are included as buffers to make sure the medicine is not too acidic or alkaline and is comfortable when administered to the eye
• although concerns have been raised about boron and a possible effect on future fertility, these products can be safely given to children younger than 2 years as advised by a doctor or other prescriber
• experts have advised that the amount of liquid that can be absorbed through the eyes of young children and the way these products are prescribed mean that the daily exposure to children would be well below the calculated safety limits

Further information

See the Drug Safety Update article for information on the review of the interpretation of EU guidance on boric acid and borates as excipients, and the supporting Public Assessment Report.

Background to concerns

An EMA update to to The European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’  raised concerns about impaired fertility related to boron use. The guideline recommended that all preparations containing boric acid or borates above a threshold level (1mg/day) must include a warning in their package leaflet not to use in children under 2 years due to concerns around impaired fertility.

Prior to the MHRA review, the Royal College of Ophthalmologists published a safety alert statement highlighting points for consideration.

Product Information

Product information for some chloramphenicol eye drops was changed earlier this year to include a warning not to use in children under 2 years, due to boron content. Subsequent advice from the MHRA has requested removal of this warning. Products are not being recalled so for a time, there will be some chloramphenicol eye drops available that include the warning in their patient information leaflet. With leaflets that contain the warning; parents and carers can be reassured these products can be safely given to children under 2 years as prescribed.

Update history