麻豆传媒

The CDC warned of a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa linked to various brands of artificial tear drops.

An investigation identified artificial tears as a common exposure for many patients. Patients reported using over 10 different brands of artificial tears; EzriCare Artificial Tears, an over-the-counter product, was most common.

Pending additional guidance from the CDC and FDA, "patients and healthcare providers should immediately discontinue using EzriCare Artificial Tears," the CDC said in an advisory to its .

Infections were identified in 55 patients in 12 states (California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington, and Wisconsin). Outcomes included hospitalization, 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 U.S. 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 February 1, EzriCare, a generic over-the-counter drug company whose artificial tears were manufactured by Global Pharma Healthcare in India, issued a 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," EzriCare stated.

Global Pharma Healthcare announced it was voluntarily on February 1 as well.

In a on Thursday, the FDA said people should immediately stop using EzriCare Artificial Tears and Delsam Pharma's Artificial Tears. The agency 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."

FDA also announced an on Global Pharma Healthcare, which prevents the company's products from entering the U.S.

Patients using EzriCare Artificial Tears should ask their provider for an alternative product, the CDC said. Individuals should seek medical care if they have 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.

Healthcare providers should advise patients who used EzriCare Artificial Tears to monitor for infection and should perform culture and antimicrobial susceptibility testing when clinically indicated. They also should ask patients they are treating for keratitis or endophthalmitis whether they have used the product. Providers should consult a specialist with knowledge of antibiotic resistance when treating VIM-GES-CRPA infections.

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 should be used. For now, the CDC does not recommend testing patients who have used the product who don't have signs of infection.

Isolates were found in clinical cultures of sputum or bronchial wash (13), cornea (11), urine (7), other nonsterile sources (4), blood (2), and from rectal swabs (25) collected for surveillance from both inpatient and outpatient settings.

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