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US health officials say the eye drops may have killed one person and seriously injured several others due to drug-resistant bacterial contamination.
The Centers for Disease Control and Prevention (CDC) has identified 68 patients in 16 states carrying a rare strain of Pseudomonas aeruginosa.
The strain had never been found in the United States before this latest outbreak.
In addition to death, eight patients suffered vision loss and four had their eyes surgically removed.
Most patients diagnosed with the infection reported using eye drops and artificial tears, according to the CDC.
Ten different brands were initially identified as possibly linked to the outbreak, the CDC said. Eye drops made in India and imported into the United States under two brands were then pulled from shelves in January and February.
In January, the CDC warned people to stop using EzriCare artificial tears and Delsam Pharma artificial tears. The following month, the company that owns the brands – Global Pharma – issued a voluntary recall following a formal recommendation from the Food and Drug Administration (FDA).
Tests found open bottles taken from patients contained the bacteria, the CDC said. Unopened bottles are currently being tested to determine if contamination has occurred during the manufacturing process.
Last week, a Florida woman sued the drug company, claiming an infection she suffered after using their product forced doctors to remove her eye.
A lawyer for the woman blamed the contamination on a lack of preservatives in the eye drops.
“There are probably a lot more people who have had infections who don’t know it,” attorney Natasha Cortes told NBC News.
A representative from EzriCare said testing so far has not definitively linked the outbreak to their products.
“Where possible, we have reached out to customers to advise them against continuing to use the product,” a spokesperson said.
“We also immediately contacted the CDC and FDA and indicated our willingness to cooperate with any requests they made to us.”
The CDC said anyone who used the recalled products and now has symptoms should contact a doctor.
Symptoms include yellow, green, or clear eye discharge, discomfort or pain, redness, blurred vision, and increased sensitivity to light.
Last week, the FDA issued separate recall notices for certain eye drop products distributed by Pharmedica and Apotex after the companies said they voluntarily pulled them from shelves.
According to Statista, a market research company, eye drops and eyewashes were used by about 117 million Americans in 2020.