Three people have died, and a dozen people have experienced vision loss, including surgical removal of their eyes, due to a rare strain of highly drug-resistant bacteria that US authorities allege originated from contaminated artificial tears manufactured in India.
The latest update comes after the US Food and Drug Administration (FDA) issued an urgent product recall on 2 February 2023 for Global Pharma Healthcare and its artificial tears lubricant eye drops, distributed to US consumers as EzriCare Artificial Tears and Delsam Pharma Artificial Tears, due to possible contamination.
At the time of the recall, the outbreak of carbapenem-resistant Pseudomonas aeruginosa – a rare strain of extensively drug-resistant bacteria that had never been found in the US previously – had affected 55 patients in 12 states. But as of 14 March, this was expanded to 68 patients in 16 states.
“Thirty-seven patients were linked to four healthcare facility clusters. Three people have died and there have been eight reports of vision loss and four reports of enucleation (surgical removal of eyeball),” the US Centers for Disease Control (CDC) said.
“Most patients reported using artificial tears. Patients reported over 10 different brands of artificial tears and some patients used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported.”
The CDC continued: “This was the only common artificial tears product identified across the four healthcare facility clusters. Laboratory testing by CDC identified the presence of VIM-GES-CRPA (the bacterial strain) in opened EzriCare bottles from multiple lots; these bottles were collected from patients with and without eye infections and from two states. VIM-GES-CRPA recovered from opened products match the outbreak strain. Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing.”
Global Pharma Healthcare agreed to voluntarily recall all lots within expiry of its Artificial Tears Lubricant Eye Drops, distributed by EzriCare, LLC- and Delsam Pharma.
Following a subsequent FDA request, Global Pharma Healthcare has extended the recall to Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination.
The US drug regulator has issued an alert to immediately halt use and importation of an artificial tears eye drops manufactured in India that has been linked to permanent vision loss and one death.
On 2 February, the Food and drug Administration (FDA) said Global Pharma Healthcare was voluntarily recalling its Artificial Tears Lubricant Eye Drops, distributed to consumers as EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, due to possible contamination.
The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of infections possibly linked to the use of the artificial tears manufactured by the Chennai-based firm, which was alleged to have breached manufacturing standards.
“The FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging,” the FDA stated.
“Associated adverse events include hospitalisation, one death with bloodstream infection, and permanent vision loss from eye infections.”
The FDA also placed Global Pharma Healthcare on import alert “for providing an inadequate response to a records request” and for not complying with CGMP requirements. The import alert prevents these products from entering the US.
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