Are Any of Them Safe to Use?
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When it comes to nonprescription drops for dry eyes, 2023 has been a banner year — in a very bad way.
More than two dozen over-the-counter (OTC) lubricants, or artificial tears, were identified as potentially risky by the U.S. Food and Drug Administration (FDA) because of possible bacterial contamination.
Reports of drug-resistant bacterial eye infections began in several U.S. states in 2022, and in early 2023, the Centers for Disease Control and Prevention (CDC) traced them to two brands of eye drops from the same manufacturer. The products, made primarily in India, have been linked to four deaths, 14 cases of permanent vision loss, and four surgical removals of an affected eye.
RELATED: Eye Infections Tied to Tainted Eye Drops Are Highly Contagious, CDC Warns
Subsequently, the FDA issued consumer warnings about several more brands of OTC eye drops that had not been associated with outbreaks of infection but that had been found to be manufactured under unsanitary conditions, meaning they were at risk of contamination.
Unsafe Products Should Be off the Shelves Now
Today, the FDA says harmful products are no longer available.
“Consumers can safely purchase anything on the market right now,” says Jeremy Kahn, media relations director for the FDA.
But if the millions of Americans with dry eye remain wary, it’s understandable. The FDA doesn’t approve OTC products in the same way it does prescription products, with multiple layers of clinical trials, but the agency does routinely inspect manufacturing plants, including overseas plants, for clean, sterile practices.
Those visits slowed during and immediately after the COVID-19 pandemic, when tainted products entered the global supply chain.
“COVID obviously hampered some surveillance overseas,” says Kahn.
Expert Advice on Purchasing OTC Eye Drops
So where does this leave consumers today? We asked several experts who’ve closely tracked this story:
- Gary Novack, PhD, a pharmacologist and clinical professor in the department of ophthalmology and vision science at the University of California in Davis School of Medicine
- Timothy Janetos, MD, assistant professor of ophthalmology at Northwestern University Feinberg Medical School in Chicago, and coauthor of an editorial on the regulation of OTC eye products published in the November 2, 2023, issue of JAMA Ophthalmology
- David Younessi, a medical student at Northwestern University Feinberg School of Medicine and a coauthor of the editorial
These interviews have been edited for length and clarity.
Everyday Health: Are OTC lubricant eye drops now safe?
Timothy Janetos: The vast majority — more than 99 percent — are safe. But the extent of safety issues is unknown, in part because there aren’t reliable ways to track these beyond sporadic FDA communications.
Gary Novack: All the questionable products should be gone from pharmacies at this point, so you don’t have to worry about available products. But it’s possible that independent stores or internet sites still have recalled drops, or that individuals have unexpired products at home.
That’s why, before using anything, you should check the FDA website or consult a trusted pharmacist. And discard products you’re unsure about or that have expired.
EH: With eye drops sold under such house brands as CVS Health, Rite Aid, and Target, how do we know which brands to trust?
David Younessi: We’re conducting a study right now to answer that by investigating whether factors such as price, consumer ratings, and marketing claims are directly associated with issues of safety, adverse events, or allergens. So far, we haven’t identified potential predictors, but the research continues. What makes it tough is the lack of existing data about how these drops manage common conditions and symptoms.
GN: One thing we do know: To date, none of the recalled products came from major vision-care companies. Alcon, which makes Systane drops; Bausch and Lomb, which makes SootheXP; Allergan, which makes Refresh; and Johnson and Johnson, which makes Blink haven’t been cited. Sticking with established vision-care companies may make sense now.
EH: Do these recalls mean that foreign-made products could be risky?
GN: The FDA reports that approximately half of all drugs sold in the United States — some 2,218 — are made here, and the other half are made in other countries. With those numbers, it’s not realistic to assume that foreign-made products are unsafe. The issue is that our inspectors simply cannot check every product all the time.
TJ: The FDA is suggesting 2024 rule changes that would require overseas manufacturers to provide at least six months advance notice of their intent to distribute products in the United States. That would give the agency ample time to conduct on-site inspections prior to their distribution.
EH: What should we know when buying artificial tears?
GN: Unless there’s actual mold in the bottle, most sterility or stability issues are undetectable by consumers, so I suggest these guidelines:
- Stick with trusted products, use them as prescribed, discard anything that’s expired.
- If possible, buy from a brick-and-mortar store with a professional pharmacist available to answer questions.
- Consider selecting single-dose vials rather than multi-dose bottles. The single doses are more likely to be contamination-free. If you prefer the typically less-expensive, multi-dose bottles, find products that include a preservative or are sold in specially designed containers to minimize contamination.
- Whatever you choose, administer the drops properly. The American Academy of Ophthalmology offers instructions on the right way to instill a single drop without touching the tip to the eye, which might cause contamination.
EH: When are preservative-free eye drops preferable?
GN: Some people find preservatives irritating, so they’re willing to pay a bit more for preservative-free formulas. It’s important to know, though, that some of the recalls involved both preservative-free and preservative-containing products.
EH: How can you tell if you’ve somehow used a tainted product?
DY: Redness, irritation, discharge, or pain from the eye can indicate an infection, but that doesn’t mean it came from a tainted eye drop. That’s why you should always seek medical attention for eye symptoms.
EH: Besides using artificial tears, what can people with dry eye do?
DJ: There are several ways to reduce the irritation, including taking regular breaks from looking at the computer or other electronic devices, using a humidifier, and protecting your eyes from the wind. Thankfully, dry eye rarely causes permanent ocular damage, so we’re really treating symptoms.
GN: The best overall preventive is to visit an ophthalmologist or optometrist annually. It’s that simple.
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