In a reversal of recent updates to the prescribing information for some chloramphenicol eye drops, the MHRA has advised these products can be safely administered to children aged 0 to 2 years.
Licences for chloramphenicol eye drops containing borax or boric acid buffers had previously been updated to restrict use in children younger than 2 years of age following a European ruling based on concerns about a possible effect of boron exposure on future fertility.
However, after reviewing the available evidence and consulting independent experts, the MHRA has now concluded that a typical regimen of one drop, applied typically 3 to 4 times a day to both eyes, would result in a daily boron exposure well below the safety limit in children aged 0 to 2 years.
The product information for affected chloramphenicol preparations is being updated to reflect the revised advice and remove restrictions for use in infants. MIMS drug listings will be updated in line with the revised product information.
In the meantime, the MHRA says parents and caregivers can be reassured 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.
The MHRA's advice is in line with a statement previously issued by the Royal College of Ophthalmologists, which said 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.'