Chloramphenicol eye drops: GPs criticise lack of guidance over use in under 2sBMJ 2021; 373 doi: https://doi.org/10.1136/bmj.n1252 (Published 14 May 2021) Cite this as: BMJ 2021;373:n1252
GPs have been left with no guidance on the use of chloramphenicol eye drops for children aged under 2 years despite the UK’s drug regulator knowing for three years that the products were no longer recommended for this age group.
The licence for chloramphenicol eye drops was changed in 2017 after the European Medicines Agency said that products delivering more than the permitted daily exposure to boron should be avoided because of concerns about effects on future fertility. For children under 2 the maximum permitted daily exposure is 1mg a day.1 Manufacturers were given three years to change their product information to say that chloramphenicol eye drops should not be used in children under 2.
In an editorial in the Drugs and Therapeutics Bulletin James Cave, a GP in Newbury and the publication’s editor in chief, said that poor communication concerning “this major change to the use of chloramphenicol eye drops” could waste GPs’ time, lead to inappropriate prescribing, and increase antimicrobial resistance.2
“Given that this has been on the cards since 2017, it is unclear why the Medicines and Healthcare products Regulatory Agency [MHRA] and relevant NHS bodies did not alert clinicians to the likely impact of the EMA’s guidance well before the mandatory changes to the marketing authorisation took place. At the time of writing none of these bodies have issued any advice or guidance on the matter and the British National Formulary for Children has not been updated to reflect the change,” said Cave.
The licence changes mean that pharmacy schemes that used to manage conjunctivitis in children under 2 have been suspended, leaving GPs to handle all cases.
Cave said that, in the absence of guidance, GPs may spend time looking for a chloramphenicol eye drop preparation that is still licensed for children aged under 2 years or may not know about the ban and be challenged by pharmacists. He said, “Some might decide to use a different antibiotic preparation, unaware that it too might contain boron (such as gentamicin) or be extremely expensive (eg, fusidic acid at £35 a tube) resulting in use of second- or third-line preparations that might increase the development of microbial resistance.”
In April this year the Royal College of Ophthalmologists published a statement suggesting that the “benefits of chloramphenicol eye drops in paediatric ophthalmic practice for appropriate indications and with courses of appropriate duration outweigh the possible risks posed by boron ingestion.”3
Cave too said that the risk posed by boron salts to children from a short course of chloramphenicol 0.5% eye drops “seems marginal.” An alternative would be chloramphenicol eye ointment, although he acknowledged its use was more difficult in young children.
He concluded, “Until we receive further guidance clinicians will need to fully understand and determine the benefits and risks of chloramphenicol eye drops in the treatment of conjunctivitis and discuss these with parents.”
In a statement the MHRA said it was urgently reviewing the available evidence on chloramphenicol eye drops and that it “will also consider appropriate ways of communicating this information to clinicians,” adding, “We understand the urgency of this issue for patients and clinicians and we are working urgently to reach a prompt resolution.”