The manufacturer of EzriCare Artificial Tears over-the-counter eye drops said it is recalling the product after being linked to a drug-resistant bacteria strain that has caused at least one person’s death and vision loss in five others. The Centers for Disease Control and Prevention (CDC) is advising people to stop using the eye drops, as they investigate an outbreak of a strain of the bacteria pseudomonas aeruginosa.
This bacteria can cause infections in the blood, lungs and other parts of the body. This strain of the bacteria had never been identified in the United States before the current outbreak and is resistant to a class of antibiotics called carbapenems, which are generally considered a last resort. The bacteria strain had been found in 55 people in 12 states according to the CDC. The CDC says the infections have caused one death, vision loss in five of 11 people who had eye infections, and some hospitalizations. The Food and Drug Administration (FDA) says the recall also included Delsam Pharma’s Artificial Tears, which are made by Global Pharma, the Indian company that manufactures the EzriCare eye drops. Global Pharma said that it was recalling the eye drops “out of an abundance of caution.”
The C.D.C. has found the drug-resistant bacteria strain in opened bottles of the EzriCare eye drops collected from patients with and without eye infections. The agency is testing unopened bottles to determine if contamination occurred during the manufacturing process. The bacteria strain was found in people in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin between May 2022 and January, according to the C.D.C. Of those 55 cases, 35 were linked to four health-care facility clusters, the agency said.
The C.D.C. said that people who have used EzriCare Artificial Tears and who have signs of an eye infection should seek medical care immediately. The symptoms can include yellow, green or clear discharge from the eye, redness of the eye or eyelid, increased sensitivity to light and eye pain or discomfort.
Dr. Thomas Steinemann is an eye surgeon in Cleveland, Ohio and he has only ever heard of preservative-free eye drops that were available in single-use vials that cannot be closed and used again later. “That to me stuck out when I read the C.D.C. report is that, at least for EzriCare, these products are dispensed in what we call multi-dose bottles, meaning that people are reusing the bottle,” Dr. Steinemann said. “But the bottle doesn’t have any preservatives, which I think might set the stage for either contamination or bacterial overgrowth in the bottle.” When people use any type of eye drops, Dr. Steinemann said, they should wash their hands, close the bottle after using it and not touch the tip, because that would risk making the drops not sterile. “Don’t touch the bottle to your eye or to your face or to your nose,” he said.
Public health officials have warned that more must be done globally to stem the spread of drug-resistant infections, which occur when bacteria and fungi evolve to outsmart the antibiotic and antifungal drugs that have been developed to destroy them. The more antibiotics and antifungal medicines are given to people and livestock, the more likely resistance will occur, health officials have said. Nearly 30,000 people in the United States died in 2020 from drug-resistant infections, according to an analysis by the C.D.C., 15 percent more than in 2019. The increase was driven mostly by the coronavirus, which in the early days of the pandemic was a mystery to medical professionals. Many turned to antibiotics to try to treat the illness before vaccines and other treatments were available.
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