|Articles|April 3, 2023

CDC, FDA Investigating Eye Drops Linked to Bacterial Infection

According to the CDC, the outbreak strain of carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA), has never been reported in the US prior to this outbreak.

The CDC recently reported it was continuing to collaborate with the FDA, state and local health departments on its investigation into an ongoing outbreak causing a bacterial infection with VIM-GES-CRPA, a rare strain of extensively drug-resistant P aeruginosa to 68 patients in 16 states as of March 14. Prior to this outbreak, this type of infection had never been reported in the United States.The states reporting cases thus far include: CA, CO, CT, FL, IL, NC, NJ, NM, NY, NV, PA, SD, TX, UT, WA, and WI.

The outbreak is associated with multiple types of infections, including eye infections. Three people have died and there have been 8 reports of vision loss and 4 reports of enucleation. The investigation to date has identified artificial tears as a common exposure for many patients.

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 according to CDC. This was the only common artificial tears product identified across the four healthcare facility clusters.

Facilities, providers, and patients should discontinue use of EzriCare or Delsam Pharma’s Artificial Tears pending additional guidance from CDC and FDA. The FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program.

“VIM-GES-CRPA isolates associated with this outbreak have been extensively drug-resistant (XDR). Isolates that underwent testing at public health laboratories were not susceptible to cefepime, ceftazidime, piperacillin-tazobactam, aztreonam, carbapenems, ceftazidime-avibactam, ceftolozane-tazobactam, fluoroquinolones, polymyxins, amikacin, gentamicin, and tobramycin,” the CDC reported on its website. “A subset of 5 isolates that underwent antimicrobial susceptibility testing for cefiderocol were susceptible to this agent. This subset of isolates also had MICs for aztreonam-avibactam ranging from 4 – 16 μg/mL, but clinical breakpoints have not been established for this antimicrobial agent combination.”

With the widely reported drug-resistance, Bacteriophage (phage), may be a potential secondary treatment, as it hasdemonstrated activity against the outbreak strain according to reporting from the University of California at San Diego’s Center for Innovative Phage Applications and Therapeutics (IPATH). Clinicians interested in phage as a treatment option should contact IPATH at [email protected].


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