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US health officials say 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 with a rare strain of Pseudomonas aeruginosa.
The species had never been found in the US before this latest outbreak.
In addition to the one death, eight patients have suffered vision loss and four have 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 related to the outbreak, according to the CDC. Eye drops made in India and imported to the US under two brands were subsequently pulled from shelves in January and February.
In January, the CDC warned people to stop using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. The following month, the company that owns the brands – Global Pharma – issued a voluntary recall based on a formal recommendation from the Food and Drug Administration (FDA).
Opened bottles taken from patients were found to contain the bacteria through testing, the CDC said. Unopened bottles are currently being tested to determine if contamination has occurred during the manufacturing process.
Last week, a woman in Florida sued the pharmaceutical company, claiming that an infection she contracted after using their product forced doctors to remove one of her eyes.
A lawyer for the woman blames the contamination on a lack of preservatives in the eye drops.
“There are probably a lot more people who have contracted infections without being aware of it,” attorney Natasha Cortes told NBC News.
An EzriCare representative has said that testing so far has not definitively linked the outbreak to their products.
“As far as possible, we have contacted customers to advise them not to continue using the product,” said a spokesperson.
“We also immediately contacted both CDC and FDA and expressed our willingness to cooperate with any requests they may have from us.”
The CDC said anyone who has used the recalled products and is now experiencing symptoms should contact a doctor.
Symptoms include yellow, green, or clear discharge from the eye, discomfort or pain, redness, blurred vision, and increased sensitivity to light.
Last week, the FDA issued separate recall notices for some eye drop products distributed by Pharmedica and Apotex after the companies said they voluntarily pulled them from shelves.
According to market research firm Statista, eye drops and eyewash products were used by approximately 117 million Americans in 2020.