Risks of permanent vision loss and death due to possible contamination have led to a product recall by the US Centres for Disease Control & Prevention (CDC) after a multi-state outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa linked to artificial tear drops, most produced by Global Pharma Healthcare in India.
Medpage Today reports that the investigation identified the product as a common exposure for many patients – with more than 10 different brands in the line-up; EzriCare Artificial Tears, a generic product, being the most common.
Infections were identified in 55 patients in 12 states, with severe outcomes including hospitalisation, permanent vision loss from cornea infection, and one death due to systemic infection. Patients presented with symptoms including keratitis, endophthalmitis, respiratory infection, urinary tract infection and sepsis.
The outbreak strain – Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase carbapenem-resistant P. aeruginosa (VIM-GES-CRPA) – had never been reported in the US before, according to the CDC, and was found in open bottles of EzriCare Artificial Tears provided by patients.
VIM-GES-CRPA in bottles could represent bacterial contamination either during use or during the manufacturing process, the CDC noted. Testing of unopened bottles is ongoing.
On 1 February, EzriCare issued a press release recommending patients discontinue using “any portions of EzriCare Artificial Tears Lubricant Eye Drops you may have until we can discover more details about any potential safety concerns”.
“The same product is also marketed under other brand names,” the company said. On the same day, Global Pharma Healthcare announced it was voluntarily recalling its Artificial Tears Lubricant Eye Drops.
And in an advisory to its Health Alert Network, the CDC said that pending additional guidance from the CDC and FDA, “patients and healthcare providers should immediately discontinue using EzriCare Artificial Tears and Delsam Pharma Artificial Tears”.
The CDC said it had recommended the recall of the products due to multiple manufacturing violations by Global Pharma Healthcare, “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 also announced an import alert on Global Pharma Healthcare, which prevents the company’s products from entering the US.
Patients using EzriCare Artificial Tears should ask their provider for an alternative product, the CDC said, and seek medical care if they showed signs or symptoms of infection including eye discharge, eye pain or discomfort, redness of the eye or eyelid, feeling of something in the eye, increased sensitivity to light, or blurry vision.
The isolates in this outbreak are not susceptible to cefepime, ceftazidime, piperacillin-tazobactam, aztreonam, carbapenems, ceftazidime-avibactam, ceftolozane-tazobactam, fluoroquinolones, polymyxins, amikacin, gentamicin, and tobramycin, the CDC stated. A subset of isolates that underwent testing were susceptible to cefiderocol.
Patients who are infected should be placed in isolation and contact precautions should be used.
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