The UK drug regulator has warned of possible contamination of certain batches of eye gels, thought to contain the bacteria Burkholderia cenocepacia that can be of particular risk to people with cystic fibrosis.
The safety advice from the Medicines and Healthcare products Regulatory Agency (MHRA) follows an ongoing investigation conducted by the UK Health Security Agency (UKHSA) after a small number infections were identified.
The warning adds to a string of eye drop recalls globally in 2023. In the US, contaminated artificial tears allegedly manufactured at an Indian lab have been linked to dozens of hospitalisations, vision loss, four enucleations and four deaths. Since then, US Food and Drug Administration (FDA) has issued more than 60 product warnings for unapproved products.
Now, in the UK, patients and users of the affected products have been advised to stop using them immediately and to return them to the place of purchase.
Anyone feeling unwell, for example with symptoms of eye infection, such as reduced vision, red and painful eye, are encouraged to contact a healthcare professional and tell them that they have been using a recalled eye gel.
These types of products are known as carbomer-containing eye gels and are used to relieve the symptoms of dry eye. Those branded Aacarb, Aacomer and Puroptics, have a potential risk of microbial contamination, which can cause an infection if the gel is used, MHRA stated.
Investigations are ongoing to determine if there is a link between the infections which have been identified and these products.
MHRA chief safety officer Ms Alison Cave said action is being taken as a precaution and the risk to the public is considered low.
“Retailers should, where possible, contact patients who have been dispensed any of the affected batches and ask them to return the product,” she said.
“We are working very closely with our colleagues at UKHSA and will issue further advice to protect patients and the public, if needed.”
People with cystic fibrosis and patients with certain risk factors are at higher risk of adverse effects from Burkholderia cenocepacia – the bacteria which may have caused the microbial contamination.
As a precautionary measure, and until further information is available, UKHSA is additionally recommending that all carbomer-containing lubricating eye gels are avoided where possible in individuals with cystic fibrosis, patients being cared for in critical care settings (e.g. intensive care), those who are severely immunocompromised and in hospital, and patients awaiting lung transplantation.
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