Carbomer-containing eye gels branded Aacarb, Aacomer and Puroptics have a potential risk of microbial contamination, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned.
Precautionary safety advice regarding possible infection from the gels has been issued. Healthcare professionals and retailers have been advised to withdraw the products, and the MHRA is urging patients to stop using them immediately and return them to their place of purchase.
‘Retailers should, where possible, contact patients who have been dispensed any of the affected batches and ask them to return the product,’ said Alison Cave, MHRA chief safety officer.
Users with symptoms of eye infection, such as reduced vision and red or painful eyes, have also been advised to contact a healthcare professional.
The issue was identified as part of an investigation conducted by the UK Health Security Agency (UKHSA) after a small number of cases of infection were identified. However, investigations are ongoing and are not conclusive, MHRA said, adding that the risk to the general public is considered to be low.
‘We are working very closely with our colleagues at UKHSA and will issue further advice to protect patients and the public, if needed,’ said Ms Cave.
Individuals 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, the 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, those awaiting lung transplantation and anyone who is severely immunocompromised.
The MHRA is urging healthcare professionals, or anyone who suspects they may have become unwell after using these eye gels, to report it to the agency’s Yellow Card Scheme.
Have your say
Please add your comment in the box below. You can include links, but HTML is not permitted. Please note that comments are not moderated before publication and the views expressed are those of the user and do not reflect the views of The Pharmacist. Remember that submission of comments is governed by our Terms and Conditions. You can also read our full guidelines on article comments here – but please be aware that you are legally liable for any libellous or offensive comments that you make. If you have a complaint about a comment or are concerned that a comment breaches our terms and conditions, please use the ‘Report this comment’ function to alert our web team.