Authorities recommend clinicians and patients avoid using certain multidose, preservative-free products, pending additional guidance.
Cases of severe eye infections leading to vision loss caused by contaminated multidose artificial tears has led to calls for increased vigilance for early signs of infection.
Two US case reports in JAMA Ophthalmology shone a light on the problem. Two septuagenarian patients developed drug-resistant Pseudomonas aeruginosa infections after using EzriCare multiuse artificial tears to treat their dry eyes.
The pathogenic bacteria were found in culture samples taken from the bottle of artificial tears in both cases.
Sydney-based ophthalmic surgeon Dr Daya Sharma told The Medical Republic ocular infections should be taken seriously.
“If infections are picked up early, they often have a good outcome. But if presentation is delayed for any reason, the patient can end up end up with permanent vision loss or require a corneal transplant,” Dr Sharma explained.
Both the 72-year old woman and the 72-year-old man presented in the case reports experienced disrupted vision despite extensive treatment with numerous antibiotics.
The US CDC also reports three patients have died due to the infections, while other patients have suffered vision loss or required surgical removal of the affected eye. The latest reports of infection come after the US CDC issued a health advisory in February of this year. As of March 21, more than 60 similar infections across 16 states resulting from artificial tears have been reported with most cases able to be traced back to the EzriCare product.
While the EzriCare eyedrops are not sold in Australia, they could still be purchased online, Dr Sharma said.
Dr Sharma told The Medical Republic he was not aware of any similar infections occurring in Australia, but recommended anyone who has purchased EzriCare artificial tears to cease use and dispose of them.
Ophthalmologists have turned to preservative-free artificial tears in recent years, after research showed extended use of preservative-containing products led to ocular surface toxicity.
Preservative-free artificial tears are typically sold as single-use vials to ensure sterility. However, the increased cost and waste associated with single-use vials has led companies to design multiuse bottles that claim to maintain an appropriate level of sterility.
“Unfortunately, as the current outbreak demonstrates, these designs may not always be effective,” an accompanying editorial noted.
“It is common for patients to inadvertently touch their eyes, eyelashes or eyelids while attempting to apply eye drops, thus increasing the risk of bottle contamination with skin and ocular surface flora,” the editorial authors wrote.
The FDA does not require artificial tear manufacturers to undertake clinical trials of their products before they are marketed on the proviso they follow the over-the-counter human use monograph for ophthalmic products. Consequently, there may be less oversight of the quality of products being sold.
In contrast, artificial tear products approved for use in Australia are held to higher manufacturing standards by the TGA, with the currently approved multiuse bottle using a differently designed nozzle to those sold overseas.
Dr Sharma reminded people using multiuse products to adhere to the “use by” date detailed in the instructions, typically four to six months, and to never touch the surface of the eye with the bottle, to avoid contamination and subsequent infection.
Dr Sharma also advised GPs to remain vigilant for patients presenting with red eyes after using artificial tears.
“If you suspect a corneal infection associated with Pseudomonas, these patients should be referred to an ophthalmologist straight away,” he told The Medical Republic.
