NEW YORK – US health officials said Thursday a company is recalling its over-the-counter eye drops, which have been linked to an outbreak of drug-resistant infections.
The Centers for Disease Control and Prevention sent a health alert to doctors this week, saying the outbreak has affected at least 55 people in 12 states. One died and at least five others had permanent vision loss.
The infections, including some in the blood, urine, and lungs, have been linked to EzriCare Artificial Tears. Many said they used the product, a lubricant used to treat irritation and dryness.
The eye drops are sold under the EzriCare name and are manufactured in India by Global Pharma Healthcare. The Food and Drug Administration said the company recalled unexpired lots of EzriCare Artificial Tears and another product, Delsam Pharma’s Artificial Tears.
The FDA recommended the recall due to manufacturing issues, including a lack of testing and proper packaging controls. The agency also blocked importation into the United States.
The infections were caused by a bacterium called Pseudomonas aeruginosa. Investigators discovered the outbreak strain in open bottles of EzriCare.
EzriCare, the company that markets the eyedrops in the US, said it has stopped selling the eyedrops. It also has a reference to it website Ask consumers to stop using the product.
Infections have been diagnosed in patients in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin. One person in Washington died from a blood infection.
The outbreak is considered of particular concern because the bacteria that fuel it are resistant to standard antibiotics.
Investigators found that the bacteria were not susceptible to antibiotics, which are routinely tested in public health laboratories. However, a newer antibiotic called cefiderocol seemed to be working.
How can eye drops cause infections in the blood or lungs? The eye is connected to the nasal cavity through the tear ducts. Bacteria can migrate from the nasal cavity to the lungs. Also, bacteria in these parts of the body can trigger infections elsewhere, such as in the blood or in wounds, CDC officials said.
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Associated Press writer Matthew Perrone contributed to this report.
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