Advocates are cheering FDA’s recent actions around problematic over-the-counter (OTC) eye drop products, arguing the issue has been neglected far too long.
“Historically, nobody cared about over-the-counter drugs,” Rebecca Petris, president of the Washington state-based Dry Eye Foundation, told MedPage Today. Petris added that FDA’s recent actions have given advocates hope that the industry will be more strictly scrutinized going forward.
“The good part here is we know the FDA is working really hard on eye drops now,” she said.
FDA’s scrutiny of eye drop products increased in February 2023, when the agency and the CDC identified an outbreak of Pseudomonas aeruginosa linked to EzriCare Artificial Tears and a related product made by India-based Global Pharma. In total, the outbreak affected 81 people across 18 states, including 14 who suffered vision loss, 4 who required removal of an eye, and 4 deaths.
“The tragedy with EzriCare artificial tears made the FDA aware of the potential for serious — even fatal — complications from poorly manufactured over-the-counter eye drops,” Sandra Brown, MD, a pediatric ophthalmologist at Cabarrus Eye Center in Concord, North Carolina, and the medical advisor to the Dry Eye Foundation, told MedPage Today in an email. “The FDA has been ramping up their factory inspections and enforcement actions as a result.”
The agency told MedPage Today that its recent warnings and subsequent company recalls are the result of regular monitoring and inspections.
“Our first priority is to protect consumers and alert them as soon as possible when we learn of quality problems with FDA-regulated products,” Charles Kohler, an FDA spokesperson, told MedPage Today in an email. “The recent recalls are one part of the FDA’s continuous efforts to ensure the quality of eye products and is not a response to any specific event.”
Petris said it’s important that the agency has become more serious about cracking down on manufacturing and selling of potentially dangerous eye care products.
Following the early February warning and recall of EzriCare and Delsam eye drop products, two more companies recalled eye care products due to sterility concerns in March: Apotex and Pharmedica. Over the summer, FDA warned about products from Dr. Berne’s and LightEyez due to bacterial or fungal contamination.
Most recently, FDA warned customers about a long list of eye care products sold at major retailers, including CVS, Rite Aid, Target, and Walmart. Manufacturer Kilitch Healthcare India subsequently announced a recall of those products.
FDA also sent a warning letter to Amazon over 7 eye care products sold on its website, charging that the products are unapproved new drugs, as they make claims about treating disease.
Problems with eye drops were first identified in May 2022 in Los Angeles County in California, according to the Associated Press. Before the end of summer that year, a total of four cases of eye infection with Pseudomonas aeruginosa had been identified in California, and similar cases started popping up across the country. Ultimately, the bacteria were genetically linked, according to the AP.
Kourtney Houser, MD, an ophthalmologist at Duke Health in Durham, North Carolina, said she’s staying up-to-date on the FDA alerts and assuring patients that there are still trustworthy eye drop products on the market, such as from the major brands — Bausch+Lomb, Allergan, and Alcon. She has told patients to avoid any generic eye drops while the recalls are ongoing.
“We get a lot of questions from patients,” Houser told MedPage Today. “Patients are scared, as they should be. I think it’s scary as an ophthalmologist as well because this isn’t something that we expected to encounter or have encountered before.”
Kevin Miller, MD, an ophthalmologist at the University of California Los Angeles, acknowledged that this string of recalls is unprecedented, but said he also believes there is danger in scaring people away from using needed medications.
“I don’t think we should stop treating dry eye or stop treating glaucoma because there’s a few bad products on the market,” Miller told MedPage Today. “We’d have worse problems if people stop using glaucoma drops because they’re concerned about the potential, rare possibility that they would have contaminated drops handed to them.”
Petris said she expects more action will be taken to rein in eye care products in online consumer marketplaces.
“E-commerce providers need to stop allowing third-party sellers to sell over-the-counter drugs that are not registered with the FDA that will keep out a lot of risky things from the market,” Petris said. “Manufacturers need to let people know where their products are made, so consumers have a choice.”
Petris noted that EzriCare had more than 2,000 reviews and 4.5 stars on Amazon before the outbreak appeared. It is nearly impossible for consumers to identify safe eye drop products online, she added.
While the FDA can do more to address issues with online retailers, Brown explained that more work should be done in Congress as well, including increasing FDA’s funding for overseas inspections and passing laws to improve packaging labels on over-the-counter eye care products.
“This will empower consumers to make their own choices regarding quality and safety versus price,” she said.
Petris also warned of the potential for products that are currently still available to be recalled in the near future.
“This is a time for great caution about over-the-counter eye drops, particularly [those] sold online,” Petris said. “We’re expecting more. As they keep inspecting more factories, more stuff is going to come to light.”
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Michael DePeau-Wilson is a reporter on MedPage Today’s enterprise & investigative team. He covers psychiatry, long covid, and infectious diseases, among other relevant U.S. clinical news. Follow
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