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How to Find Safe Eye Drops Amid FDA Warnings

Safety alerts spark caution among consumers


spinner image illustration of a yellow and white FDA-approved safe eye drops bottle on a light green background
diane555 / Getty Images

Amid a surge of recalls over the past two years, it’s no surprise that people are becoming increasingly cautious when reaching for their over-the-counter eye drops.

The primary concern centers around eye drops manufactured in unsanitary conditions, which elevates the risk of harm, because any drug applied to the eyes may bypass the body’s natural defense system, experts say.

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“These are all primarily over-the-counter lubricating eye drops (commonly referred to as artificial tears) and are used for the symptomatic relief of dry eye symptoms like grittiness, foreign body sensation, dryness, itching, etc.,” said Christopher Starr, M.D., spokesperson for the American Academy of Ophthalmology, in an email.

To help protect your eyes from an infection, here are some expert tips on identifying eye drops that are safe to use, lifestyle changes that can lessen your dependence on OTC solutions, and a glimpse into the FDA’s strategy for addressing the issue.  

How to find eye drops that are safe to use

Verify where the product is manufactured. Due to the current a lack of regulations for these OTC products, try to buy eye drops that are manufactured by U.S.-based companies, says Shane Kannarr, an optometrist and clinical researcher at Kannarr Eye Care in Pittsburg, Kansas. He recommends Allergan (Refresh), Bausch + Lomb (Blink and Soothe XP) and Alcon (Systane), to name a few.

The latest eye drop recalls involve generic products distributed by CVS, Cardinal Health, Rite Aid, Target and Walmart. They were manufactured in India by Kilitch Healthcare.

“While the drops recalled are ‘major brands,’ they were all generic or a value [eye] drop,” he says. “I would attempt to focus on more branded products for purchase at this time.”

If you’re ever concerned about a product, don’t use it. Then reach out to the manufacturer or your eye doctor for advice.

Purchase from trusted retailers. Focus on buying eye drops from brick-and-mortar stores. If you choose to shop online, purchase only from trusted sellers. When shopping on Amazon, buy only at the manufacturer’s store rather than from third-party sellers. Just because a product ships from Amazon does not mean it is coming from the manufacturer, advises Sandra Brown, M.D., a board member and medical adviser at the Dry Eye Foundation.

Be aware that the FDA has increased its scrutiny of “natural” homeopathic eye drops, some of which have been found to be contaminated with bacteria or fungus, says Brown. 

Utilize resources. Use the Dry Eye Foundation’s eye drop safety tool to identify potentially unsafe eye drops. Otherwise, stay informed about any product recalls announced by the FDA or mentioned in the news.

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Check expiration dates. When using a product, always follow the manufacturer’s directions, and abide by the dosing and expiration dates.

Never stop taking prescription eye drops without consulting your doctor. These drops are more tightly regulated than OTC eye medications.  

Lessen dependence on eye drops

Try to reduce your dependence on eye drops. To eliminate or lessen the need for OTC eye drops, Kannarr recommends drinking more than 80 ounces of water per day, limiting caffeine, practicing good hygiene, and eating fish or taking an omega-3 supplement.

“The best remedies have a long-established track record,” he says. “Remember, dry eye is a multifactorial disease, and all artificial tears are not created the same or intended to have the same impact on the patient’s eye.”

Dry eye concerns should be discussed with an eye doctor to develop the best treatment plan. Note that prescription medications are often prescribed alongside artificial tears.  

Share your concerns with a doctor. If you are uncertain about the eye products you’re using, consult your doctor and bring the products with you to your appointment. Make sure to ask about any potential concerns the doctor has and how to safely use the product, or explore alternatives.

“Any eye care professional who is vested in their patients will be happy to discuss these options and concerns with you in detail,” says Kannarr.

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How does the FDA plan to protect consumers?

In general, there has been a lack of oversight of OTC eye products, says Kannarr. At the same time, companies are attempting to maximize their profit margins by getting their products into customers’ hands at the lowest cost to the manufacturer, he says.

This approach often involves a lack of oversight in the manufacturing process, potentially compromising the highest levels of safety. For a patient with a sick or distressed eye, that can be a recipe for an infection, he adds.

Currently, federal law does not require premarket approval for OTC eye drops. But it does require eye drops to be sterile for safe use.

“The FDA reminds manufacturers, distributors, repackagers, relabelers and importers that they are responsible for the quality of their products, and urges manufacturers to test their ingredients to ensure they meet specifications and are free from harmful contamination,” the agency told AARP in an email.

In response to the industry’s recent manufacturing issues, the FDA has been sampling and testing eye drop products, a spokesperson told AARP.

The agency also is proposing legislation that would allow it to identify and resolve these problems before consumers are exposed to dangerous products.

If approved, manufacturers would be required to have an FDA inspection for sterile manufacturing operations at least six months before a new product is distributed.

The FDA says that until then, it will continue to closely monitor both the quality of drugs intended for sale in the U.S. and the facilities where they are made.

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