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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) have identified 68 patients in 16 states with a rare strain of Pseudomonas aeruginosa.
The strain had never been found in the US prior to this recent outbreak.
In addition to the one fatality, eight patients suffered vision loss and four patients 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, according to the CDC. Eye drops, which were manufactured in India and imported into 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 next 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 that opened bottles taken from patients contained bacteria, the CDC said. Unopened bottles are currently being tested to determine if contamination occurred during the manufacturing process.
Last week, a Florida woman sued the pharmaceutical company, claiming that an infection she developed after using their product forced doctors to remove one of her eyes.
A lawyer for the woman blamed a lack of preservatives in the eye drops for the contamination.
“There are probably a lot more people who have had infections who don’t know,” attorney Natasha Cortes told NBC News.
A representative for EzriCare said testing so far has not definitely linked the outbreak to their products.
“As far as possible, we have contacted customers to advise them against further use of the product,” a spokesman said.
“We also immediately reached out to the CDC and FDA and expressed our willingness to cooperate with any inquiries they have for us.”
The CDC said anyone who used the recalled products and now has 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 sold by Pharmedica and Apotex after the companies said they had voluntarily removed them from shelves.
Eye drops and eye wash products were used by about 117 million Americans in 2020, according to Statista, a market research company.