For a many months now I have been aware that when it comes to over the counter (OTC) dry eye drops in the USA things were not quite as benign as one would expect, storms have been blowing across the landscape, primarily associated with a perceived relaxed approach to regulatory over-sight of eye drop safety and claimed health benefits, this has involved more than a handful of products and manufacturers.
Rather like Pandora’s box, upon looking into the huge range of dry eye drops available it has proved to be source of great and unexpected troubles. The afore mentioned perception by some manufacturing and distributing companies has sought to exploit weaknesses in the system of consumer protection in regards to safety and, exaggerated, if not completely false, medical claims.
To continue with my meteorological analogy, just as our prevailing weather systems move from west to east, we in the UK are not completely sheltered from short-cuts in manufacture and distribution in the global supply that have manifested themselves across the pond.
In 2023 I was aware of the deeply concerning news of eye drops associated with four deaths and 14 cases of vision loss in more than 80 infections of a rare drug-resistant strain of Pseudomonas aeruginosa. Around the same time in addition to these reports the USA Center for Disease Control (CDC) had also reported four cases of enucleation due to this infection. Some of these infections even occurred in people who did not use eye drops. but picked up the infection from other people who did.
The infections, including some found in blood, urine and lungs, were linked to EzriCare Artificial Tears (Global Pharma Healthcare). We might ask how could eye drops cause infections in the blood or lungs? As we know the lacrimal canaliculi links to the lacrimal sac and the nasolacrimal duct. The CDC explained to the public that bacteria can move from the nasal cavity into the lungs, also, bacteria in these parts of the body can seed infections at other sites such, as in the blood or wounds.
As the full picture of the scale and depth of the problem was revealed behind these eye infections which were causing irreversible sight-loss and deaths. It was at this stage the US Food & Drug Administration (FDA) held emergency discussions with the Indian based manufacturing company involved, which then had the products withdrawn from the market.
It appears that in the field of dry eye products an automatic assumption, probably held without much thought by users, is that they are completely benign and free from any potential serious adverse effect. This appalling and tragic story should completely reveal this cannot taken for granted, and my further research has shown this case cannot be assumed to be unique.
Being aware of this unfolding story in the USA, with my interest in dry eye disease, my research found a website eyedropsafety.org a foundation educating the public about illegally marketed and potentially unsafe eye drops since 2022. As Aidan Moore - Co-Executive Director said in a recent email communication to me:
"The Dry Eye Foundation has been educating the public about illegally marketed and potentially unsafe eye drops since 2022. We created eyedropsafety.org in the wake of the Ezricare Artificial Tears recall in early 2023. With numerous recalls and FDA warnings this year, we've tried to keep on top of the information and give patients practical information on which eye drops to avoid. US consumers will find a searchable OTC eye drop database at alerts.eyedropsafety.org Some products in our database have red flag warnings, while others are simply labelled as "no known current alerts." To date, we've reported over 200 eye drops to the FDA which are being sold illegally online. Thankfully, we've seen the FDA take action on a number of these products since."
One of these FDA actions was a manufacturing site visit to Global Pharma Healthcare Private Limited in Thiriporur, India where, in a subsequent letter to the company, the FDA states “because your drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health…..”
In the same letter they go on to say “…microorganisms in your products included but were not limited to the following: EZRICARE Artificial Tears contained Pseudomonas species, Delsam Pharma’s ARTIFICIAL TEARS contained Bacillus species, and Delsam Pharma’s ARTIFICIAL EYE OINTMENT contained Burkholderia cepacia complex. There is a reasonable probability that instillation of a bacterially contaminated eye product into the eye may cause a range of ocular infections, from minor to serious, vision-threatening infections which could progress in some cases to life-threatening systemic bacterial infection”1.
As I will expand on an another article, it would be reassuring to assume that this is a unique example of inadequate public protection from potential sight threatening, and in this case fatal, quality standards. This is a false assumption, although in scale and consequences this example may, so far, stand out, other potential adverse effects are in products available to consumers, and they are being sold in the UK today!
In addition to this aspect of potential adverse effects from eye drops is a situation where the necessary regulatory controls exist for the protection of the public here in the UK, but are simply not being enforced, I will expose, to the sound of the collective jaw dropping of the UK eye care community, claims being made for products that can only mislead and harm, only a click or two away on well-known web sites.
As always in these types of situations there are lessons to be learned and opportunities, the first is that we, as your eye care guardians, must make much more of an effort to educate you our patients and the public in general that the products we recommend in our practices are from world leaders in manufacturing these products and subject to stringent quality control and testing, that we know the suppliers and manufacturers of these products well. That we are a trusted source of advice and recommendations based on knowledge of their effectiveness and safety.
As always with articles in this section emails can be sent to
Sources:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-pharma-healthcare-private-limited-657325-10202023