MedPage Today: What to Know About Ongoing Eye Drop Recalls
MedPage Today 11/21/23
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.
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"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."
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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.
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"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."