What to know about ongoing eye drop recalls

Advocates are cheering the FDA’s recent actions around problematic over-the-counter (OTC) eye drop products, arguing the issue has been neglected for 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 the FDA’s recent actions have given advocates hope that the industry will be more strictly scrutinized going forward. The 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, said. 

Most recently, the 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. The 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. Kourtney Houser, MD, an ophthalmologist at Duke Health in Durham, N. C. 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. 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.”  “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 said. Problems with eye drops were first identified in May 2022 in California.   

Source: Michael DePeau-Wilson, MedPage Today,  November 20, 2023; see source article