The Centers for Disease Control and Prevention warned the public to “immediately discontinue” use of EzriCare Artificial Tears, and said the eye drops could be linked to infections across the United States that have resulted in hospitalization, vision loss and one death.
Although patients identified 10 different brands they had used, a majority had used EzriCare’s preservative-free, over-the-counter version.
The eyedrops, which are sold through Walmart and other stores, are advertised as a dry-eye treatment that “refreshes, lubricates and moisturizes.” Preservative-free eyedrops have fewer additives and are typically recommended for people who use the drops more than four times a day, according to the Mayo Clinic.
The CDC found the outbreak strain in open EzriCare bottles in two states and is testing unopened bottles to see whether they may have been contaminated during manufacturing. The CDC did not immediately respond to request for further comment early Thursday.
EzriCare, a distributor based in Lakewood, N.J., said Wednesday that it was “not aware of any testing that definitively links the Pseudomonas aeruginosa outbreak to EzriCare Artificial Tears” but “immediately took action to stop any further distribution or sale” of the product.
The product is manufactured by India-based Global Pharma Healthcare, which sells the product under other brand names, and is working with the FDA on a potential recall, EzriCare said. Global Pharma did not immediately return a request for comment Thursday.
Pseudomonas aeruginosa is found in the environment and skin and “typically enters eye drops through contamination with environmental agents during handling,” said David Chen, an ophthalmologist at Singapore’s National University Hospital. The bacteria is a “common cause of corneal infections (microbial keratitis), which can lead to permanent visual damage or blindness” if not properly treated, he wrote in an email.
Infections have presented in a variety of ways, the CDC said, including through keratitis, sepsis and respiratory and urinary tract infections. It is advising health-care providers to encourage people who have used the product to monitor for signs of infection, which include eye discharge, discomfort, redness, blurry vision or increased light sensitivity.
This particular strain of Pseudomonas aeruginosa has not previously been seen in the United States. The bacteria is difficult to treat with antibiotics, and this strain has shown some “susceptibility” to the antibiotic cefiderocol, the CDC said in its notice.
Pseudomonas aeruginosa can cause infections in the lungs, blood, kidneys and elsewhere in the body. Hospital patients are among those most at risk, the CDC says, with those who are on breathing machines, using catheters or recovering from surgical wounds or burns being particularly vulnerable. Infection is also especially threatening to those who are chronically ill or immunocompromised.
The CDC estimated the United States had about 2,700 deaths related to Pseudomonas aeruginosa and 32,600 related cases in hospitalized patients in 2017. In 2018 and 2019, there was an outbreak related to patients undergoing surgeries in Mexico.