A specific brand, EzriCare Artificial Tears, has been associated with multidrug resistant (MDR) Pseudomonas aeruginosa. In addition, FDA has sent a letter to companies making claims of prevention and treatment for mpox.
The CDC is investigating a multistate cluster of Verona Integron‐mediated Metallo‐β‐lactamase (VIM)‐ and Guiana‐Extended Spectrum‐β‐Lactamase (GES) producing carbapenem-resistant Pseudomonas aeruginosa (VIM‐GES-CRPA) associated with multiple different infection types, including eye infections.
The CDC says there are 50 cases across 11 states, and some of the patient outcomes included permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection.
The MDR-related pseudomonas infections are linked to the use of EzriCare Artificial Tears, according to the CDC. The agency warns people to refrain from using the brand.
“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 wrote on their site.
Review of common exposures among patients identified that the majority of patients used artificial tears prior to identification of VIM‐GES‐CRPA infection or colonization. The most common brand reported was EzriCare Artificial Tears, a preservative-free product dispensed in multidose bottles. Laboratory testing of EzriCare Artificial Tears by CDC identified the presence of VIM‐CRPA in opened EzriCare bottles; these VIM‐CRPA are undergoing further characterization, including testing for GES and to determine ST, to assess if they match the outbreak strain. Testing of unopened bottles of EzriCare Artificial Tears is ongoing.
On a EzriCare website, that was dated January 24, they said they had not received consumer complaints or adverse event report related to the investigation.
“Also, as of that date, EzriCare has not received communication from any regulatory agency providing any outcomes or details to EzriCare about the ongoing investigation. We have not been asked to conduct a recall. Nevertheless, and in an abundance of caution, EzriCare recommends that during this evolving situation you discontinue useof any portions of EzriCare Artificial Tears Lubricant Eye Drops you may have until we can discover more details about any potential safety concerns. Please contact us firstname.lastname@example.org with any questions or concerns.”
FDA Issues Warning Letters to Companies Claiming to Sell Products to Treat, Prevent Mpox
The FDA has sent warning letters to individual companies who are selling products saying they treat or prevent mpox.
The FDA has a full list of companies who were sent letters and there are some resources on reporting on companies make claims, as well as updates on mpox, on this page.
The federal agency reminds the public there are no FDA-approved treatments for mpox.