CDA Warns of Contaminated Eye Drops Linked to Corneal Ulcer

Category Health

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The Centers for Disease Control and Prevention warned people against using EzriCare eye drops in February 2023. Researchers have detailed a case of a 72-year-old female diagnosed with a corneal ulcer, caused by irreparable infection of the bacterium Pseudomonas aeruginosa traced to the contaminated eye drops. Treatment was difficult as the isolate was resistant to any antibiotics that could be administered and instead had to be infused intravenously for 8 weeks for the infection to clear. The eye drops have since been pulled from shelves, but the risk may still persist.

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The CDC warned against using EzriCare eye drops after they were linked to drug-resistant bacterial infections, vision loss, and death. Researchers have now detailed a case of a corneal ulcer caused by Pseudomonas aeruginosa, which was traced back to contaminated eye drops. Although the product has been removed from stores, it may still pose a risk.

In February 2023, the Centers for Disease Control and Prevention warned people against using EzriCare eye drops because bottles of the product had been linked to drug-resistant bacterial infections causing vision loss and even death. But tainted bottles had been causing problems long before then.

This is the first and only case of this kind of contamination being reported.

Last week in the journal Antimicrobial Agents and Chemotherapy, an interdisciplinary group of researchers and physicians in Cleveland, Ohio, describe a case from November 2022. The patient, a 72-year-old female, was diagnosed with a corneal ulcer, caused by infection by the bacterium Pseudomonas aeruginosa. Eventually, infectious disease physicians and microbiologists identified her contaminated eye drops as the source of the infection.

Pseudomonas aeruginosa is usually found in environments with high moisture, such as soil and water.

P. aeruginosa is a pathogenic, gram-negative bacterium that’s resistant to treatment with most antibiotics. It can cause swimmer’s ear — a painful infection of the outer ear canal — and more serious conditions, especially in people with compromised immune systems. But the case in Cleveland was unusual, said Morgan Morelli, M.D., the study’s first author and an infectious disease fellow at the hospital.

This is the first case of P. aeruginosa linked to eye drops in the US.

"I’ve never recovered it from an eye," she said. Because P. aeruginosa isn’t usually found in eye infections, she said, finding the right diagnosis was a challenge. "It required a lot of thinking and digging to figure out what was going on," she said. "And we never thought it was related to a global manufacturing issue." .

The patient initially reported to an outpatient eye clinic with blurry vision. From there, she was sent to the emergency department at the hospital, where she was evaluated by ophthalmologists. They cultured the infection, prescribed a combination of strong antibiotic eye drops, and sent her home. But the next day, the eye was worse—and she visited a cornea specialist.

The patient had to be infused with antibiotics for 8 weeks in order to clear up the infection.

The patient had noticed a yellow discharge on her pillow, and she hadn’t been swimming. "We wondered if she’d accidentally touched something, or there was some freak accident," to explain the infection, Morelli said.

At that point, Morelli said, her case was referred to microbiologists and infectious disease experts at the hospital. Infectious disease specialist Scott Fulton, M.D., asked the patient’s husband to bring in her eye drops for testing. A sample from the patient was sent to the lab of Robert Bonomo, M.D., an expert in gram-negative, drug-resistant bacteria at Case Western Reserve University School of Medicine.

The case was so rare that it required an interdisciplinary group of researchers and physicians to diagnose the patient.

Then, Morelli said, the pieces came together. Dr. Bonomo’s lab identified a P. aeruginosa isolate that matched genetic material found in the EzriCare artificial tear eye drops she’d been using. Then researchers connected the eye infection—and the ulcer it had caused—to the contaminated drops.

Treatment was tricky, Morelli said. The isolate was resistant to any antibiotics that could be administered by way of the patient’s eye. She was treated instead by a strong antibiotic, cefiderocol, that had to be infused intravenously for 8 weeks before the infection cleared and the corneal ulcer healed completely.

Contamination of the eye drops was traced back to the manufacturing facility in India.

At this point, researchers have linked fewer than fifty infections to the counterfeit drugs. The eye drops, manufactured in India, have been pulled from shelves and rebranded with the same active ingredient under a different name, but Morelli said that the risk may persist.

"We can’t be certain that there aren’t still some of these contaminated bottles circulating," she said.

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