US authorities have recalled a brand of eyedrops contaminated with a drug-resistant bacterial contamination that may have killed one person and injured 68 others, a small number of whom have to have the affected eye surgically removed.
Both the Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) issued an advisory against the use of EzriCare Artificial Tears, warning that they may be linked to an outbreak of Pseudomonas aeruginosa.
The Pseudomonas bacteria can cause infections in the blood, lungs or other parts of the body after surgery. The multi drug-resistant bacteria causes an estimated 32,600 infections among hospitalized patients and 2,700 estimated deaths in the US a year, according to a 2019 CDC report.
Last month, the FDA issued a voluntary recall of the Global Pharma brand, warning it was linked to hospitalization and blindness. It advised consumers to stop using the brand and return them to the place of purchase.
The agencies reported cases reported across 12 states – California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin – from May last year to February.
Ten different brands of eyedrops were initially linked to the outbreak of the rare strain of infection that had not been experienced in the US before, with the drops having been manufactured in India and imported to the US. The FDA has also recalled eyedrops distributed by Pharmedica and Apotex.
Most patients diagnosed with Pseudomonas aeruginosa reported using eyedrops or artificial tears. The CDC said bottles belonging to patients were found to contain Pseudomonas.
In addition to the one death, eight patients have suffered vision loss, and four have had eyes surgically removed. Common symptoms include yellow, green or clear discharge from the eye, discomfort or pain, redness, blurry vision and increased sensitivity to light.
A spokesman for EzriCare said last month that the company was “not aware of any testing that definitively links the Pseudomonas aeruginosa outbreak to EzriCare Artificial Tears”. But it said it had taken action to stop distribution of the product.
“To the greatest extent possible, we have been contacting customers to advise them against continued use of the product,” the company added.
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