Artificial tears are the mainstay of dry eye disease (DED) management, and patients typically start by using over-the-counter (OTC) drops several times a day. But how safe are those eye drops? A recent spate of government warnings and recalls has left many providers and patients concerned.
In October 2023, the FDA issued warnings for 26 OTC eye care products because of the potential for infection that could lead to vision loss or even blindness. The agency provided a list of the products on its website, and encouraged healthcare professionals and consumers to report adverse effects or quality problems.
The FDA also issued warning letters to eight companies in September 2023 for manufacturing or marketing unapproved ophthalmic drug products it said were “illegally marketed” to treat conditions including DED. The agency noted heightened risk of harm because such drops bypass some of the body’s natural defenses.
OTC eye drops are usually well-tolerated, but “they can cause side effects, including blurred vision, itching, redness, irritation, eyelid swelling, or allergic reactions,” said Jeffrey Ma, MD, of the University of California Davis Eye Center. “Common symptoms of an eye infection include pain, light sensitivity, tearing, discharge, and decreased vision.”
In August 2023, the FDA warned consumers to not purchase two brands of methylsulfonylmethane (MSM) eye drops due to bacterial contamination, fungal contamination, or both. Such contamination could result in a minor to serious vision-threatening infection that could possibly progress to life-threatening sepsis.
Simple conjunctivitis can usually be treated empirically without a culture to confirm the diagnosis and select a treatment. However, an aggressive infection associated with vision loss that does not respond to treatment requires a culture. With a very resistant organism, such as Pseudomonas aeruginosa, a consultation with an infectious disease specialist might help in selecting the best antibiotics.
CDC has received reports of deaths and vision loss due to tainted eye drops, with many linked to EzriCare Artificial Tears (now recalled). This spring, the agency identified an additional death and multiple additional cases of vision loss. In all, 81 affected patients had been identified across 18 states.
The heightened attention to OTC eye products may be a response to stricter FDA enforcement at the end of COVID pandemic-era restrictions, as well as manufacturing issues.
However, John Sheppard, MD, of Virginia Eye Consultants in Norfolk, cautioned about blowing the risk out of proportion.
“A litany of rare events has made the news. This is alarming when it’s your patient’s eyes. Contaminated eye drops come from brands I have never heard of that are in limited distribution,” he said. “I have never had complications with tear products from the United States.”
Most DED drops from reputable brands by major manufacturers are safe. These manufacturers have well-established protocols, with each lot tested for safety and tracked. Such “good” brands include Refresh, Systane, iVIZIA, TheraTears, Blink, Oasis, and Soothe, he said.
If artificial tears need to be used more than four times a day, patients are generally advised to seek preservative-free artificial tears. Ma said he generally advises against using redness-relieving eye drops, which usually contain a decongestant. “These drops may result in worsening redness upon discontinuation,” he said.
Patients with meibomian gland dysfunction, one of the most common causes of DED, often benefit most from lipid-containing lubricant drops. These drops usually contain mineral oil, flaxseed oil, or castor oil to help replace the natural oils of the tear film and provide improved tear film stability.
What recommendations can physicians make to help DED patients prevent eye infections? Patients should wash their hands before touching their fingers near their eyes. They should avoid touching the tip of the eye drop bottle to their eye. Those who require preservative-free artificial tears can purchase single-use, individual-dose vials, which cut contamination risk significantly. Patients who wear contact lenses should never sleep while wearing their lenses.
Infection often happens with some deviation from contact lens solution recommended use. The most common blinding eye infection is contact lens-associated keratitis. People who wear overnight contact lenses are at higher risk.
“Patients should use daily-wear disposable contacts, if possible,” said Sheppard. “While wearing contacts, they should not clean their sewer, basement, attic, or workshop, and avoid swimming in natural bodies of water — such as oceans or lakes — and swimming pools.”
Clinicians should also remind patients to check the expiration date of their eye drops. Expired products’ active ingredients could break down and the preservatives degrade over time.
The array of therapeutic options available for DED patients now includes more advanced agents for patients with moderate to severe dry eyes, including autologous serum drops, scleral contact lenses, and thermal eyelid treatments.
“When evaluating a patient with DED, it is still important to be systematic about identifying the underlying causes of their DED, for example, determining whether they have evaporative DED, aqueous tear deficiency, or a combination of both, as this will help guide management,” said Ma.
Ma reported no potential conflicts of interest.
Sheppard disclosed relationships with 1-800-DOCTORS, AbbVie, Alcon, Aldeyra, Allergan, Alphaeon/Strathspey Crown, ArcScan, Avedro, Bausch & Lomb, Biolayer, BioTissue/TissueTech, Bruder Healthcare, Clearside, Clearview, Clementia Pharma, Dompé, Eleven, Eyedetec, EyeGate Research, EyeRx Research, Eyevance, Glaukos, Hovione, Imprimis Pharma, Inspire/Merck, InSite Vision, Ionis Pharmaceuticals, Johnson & Johnson/TearScience/Vistakon, Kala Pharmaceuticals, Kowa, LacriSciences, LayerBio, Lenstatin, Lux Biosciences, Lumenis, Mallinckrodt, Mati Therapeutics, MedEdicus, Mitotech, NeoMedix, Nicox, NovaBay, Novaliq, Novartis, Noveome Biotherapeutics/Stemnion, OccuHub, OcuCure, Ocular Therapeutix, Oculis, Okogen, Omeros, Oyster Point, Parion, PentaVision, Pfizer, Portage, Quidel, Rapid Pathogen Screening, Rutech, Santen, Science Based Health, Senju, Shire, Sun Pharmaceuticals, Surrozen, Synedgen, Takeda, Talia Technology, TearLab, Tear Solutions, Topcon, Topivert, and Xoma/Servier.