A wave of infections across 11 states have been linked to artificial tear use, leading to permanent vision loss, hospitalization, and one death.
The US Centers for Disease Control and Prevention (CDC) has advised against the use of EzriCare Artificial Tears Lubricant Eye Drops (carboxymethylcellulose sodium, 10mg in 1mL) and is conducting an investigation into at least 50 infections across 11 states that have led to instances of permanent vision loss, hospitalization, and one death.
Most of the people with these infections reported using artificial tears, with EzriCare the most common brand, the agency said in a release from January 20. These eye drops are preservative-free, meaning they don’t have ingredients to prevent bacterial growth.
The infections, associated with Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (CRPA), were identified by the CDC between May 17, 2022, to January 19, 2023, with help of local and state health departments, and the specimens were collected in both inpatient and outpatient settings between May and December of 2022.
“Isolates have been identified from clinical cultures of cornea (10), sputum or bronchial wash (11), urine (6), other nonsterile sources (4), and blood (2), and from rectal swabs (23) collected for surveillance,” according to the January 20 CDC press release. “Patient outcomes include permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection.”
Testing of open EzriCare bottles identified Pseudomonas aeruginosa bacteria that were resistant to carbapenem antibiotics as well as the antibiotics ceftazidime and cefepime. Testing of unopened bottles is ongoing, the CDC says.
Pseudomonas aeruginosa is becoming increasingly difficult to treat due to antibiotic resistance; in 2017, it caused more than 32,000 infections in hospitalized patients and approximately 2,700 deaths in the US. Pseudomonas bacteria are often found in soil and water, but generally spreads in health care settings.
“CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete,” the agency says.
EzriCare deflected blame in a statement released on January 24, 2023. In the face of these allegations, EzriCare has recommended discontinuation of the EzriCare Artificial Tears Lubricant Eye Drops, but the company maintains that they have not received official notice of these complaints.
“EzriCare has received no consumer complaints or adverse event report related to the investigation to date,” the statement reads. “Also, as of this date, EzriCare has not received communication from any regulatory agency providing any outcomes or details to EzriCare about the ongoing investigation.”
EzriCare claims that they do not manufacture the Lubricant Eye Drops. They allege that the artificial tears are formulated, designed, and imported by Aru Pharma and manufactured by Global Pharma Healthcare.
This is a developing story.