POULSBO, Wash.—Dry Eye Foundation has identified more than 200 eye drops (62 brands) sold online that have potential safety issues. Of these, the majority are packaged exclusively for sale in a country other than the U.S. Many are advertised as preservative-free but are pictured in bottles designed only for preserved eye drops. More than 60 individual products have been found on Amazon. Dry Eye Foundation has reported all products of concern to the Food and Drug Administration, and continues to maintain a watch list for consumers and physicians.

According to the organization, digital marketplaces are flooded with eye drops from sellers that ignore Federal drug regulations, from safe packaging rules to FDA registration requirements. The manufacturing locations and conditions for many of these eye drops are unknown to the FDA.

"Most people are not aware that over-the-counter drugs, including eye drops, are regulated on an honor system," said Sandra Brown, MD, Dry Eye Foundation's medical advisor. "Unfortunately, online marketplaces such as Amazon and Walmart take no steps to vet eye drop products, so it's becoming very difficult for consumers to tell the good from the bad."

 
 
According to Dr. Brown, if a patient or eye doctor has concerns about the eye drops they are using or recommending and whether they are safe and meet FDA requirements they should do the following: “First, check DailyMed to confirm that the eye drop is listed with the FDA. If the eye drop is not listed, don't use it.

"Second, if the eye drop is advertised as preservative free, confirm that it is in a bottle designed for use with preservative-free products. A DailyMed listing does not ensure a proper bottle. And if a patient determines that they have accidentally been using an unlisted product or an improperly packaged product, they should stop using it immediately but do not discard it.

"If there are no negative effects after 14 days, it is unlikely that the eye drop caused harm and the bottle may be discarded. If they have any concerns about persistent eye redness, discharge, light sensitivity or loss of vision they should seek help from an eyecare provider immediately and take the bottle to the appointment.”

Dry Eye Foundation has reported 205 eye drops that are not found in the FDA's database, although registration with the FDA is a legal requirement for all over-the-counter eye drops.

Examples of products reported to the FDA include:

  • Counterfeits and clones of national brands.

  • Preservative-free eye drops packaged in standard eye drop bottles.

  • Unregistered imports: 72 percent of all reported products appear to be packaged for sale exclusively in a country other than the USA, and may or may not be authentic.

  • Trending scams, e.g., eye drops that claim to change eye color.

  • "Natural" eye drops, many of which claim to treat numerous unrelated medical eye diseases.
"Raising awareness about the safety hazards of purchasing eye drops online has become our top priority for 2023," said Dry Eye Foundation's executive director, Rebecca Petris. "In 2022, we were worried about three incorrectly packaged biologic eye drops. Then came the Ezricare tragedy earlier this year, which increased our sense of urgency.

"Since then our list grew to 10, 20, 50, 100 and now over 200. We have been sharing all our research with the FDA, and in the meantime, we need eyecare providers to know what's going on."

Health care professionals and consumers are encouraged to learn more about eye drop safety issues and review current product alerts here.