MHRA Update

MHRA Update

May 4, 2021

GMLPC have been made aware that the licensing for Chloramphenicol eye drops has changed: ‘This medicinal product must not be given to a child less than 2 years old as it contains boron and may impair fertility in the future.’

Paediatric contraindication for chloramphenicol eye drops | MIMS online

https://www.rcophth.ac.uk/2021/04/safety-alert-boron-additives-in-chloramphenicol-drops/

The MHRA are currently reviewing the evidence for this change, we will ensure contractors are kept updated with further information as it is made available.

Advice from GM medicines optimisation teams will be that prescribers should advise parent/carers that most cases of bacterial conjunctivitis are self-limiting and resolve within 5–7 days without treatment.  If antibiotic treatment is deemed necessary, chloramphenicol 1% eye ointment can be prescribed.

However, not all chloramphenicol ointment is licensed under 2 years, so the pharmacy would need to ensure that the particular product dispensed does have a paediatric license.

Please ensure your teams are briefed accordingly.

If you have any queries with regards to the above, please contact enquiries@gmlpc.org.uk.




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