CDC Recommends Patients Stop Using EzriCare Artificial Tears Products Pending Additional Guidance For These OTC Eye Drops

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On February 1, 2023, the US Centers for Disease Control and Prevention (CDC) issued a warning about an over-the-counter (OTC) eye drops product, EzriCare Artificial Tears, being associated with serious eye infections in patients in various states duing recent months. For a quick overview of these eye infections linked to EzriCare Artificial Tears see this CDC document, “Health Alert Network (HAN) No. 485 – Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa associated with Artificial Tears“.

Here is the “Summary” section of that February 1, 2023, CDC Health Advisory:

The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 states. Most patients reported using artificial tears. Patients reported more than 10 different brands of artificial tears, and some patients used multiple brands. The majority of patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles. CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states. Patients and healthcare providers should immediately discontinue using EzriCare artificial tears pending additional guidance from CDC and the Food and Drug Administration (FDA).

The CDC warnings for these eye infections linked to EzriCare Artificial Tears include the following, taken from a section titled “Recommendations for the Public”:

  • Discontinue using EzriCare Artificial Tears pending additional guidance from CDC and FDA.
  • If patients were advised to use EzriCare Artificial Tears by their healthcare provider, they should follow up with their healthcare provider for an alternative artificial tears product to use.
  • Patients who used EzriCare Artificial Tears and who have signs or symptoms of an eye infection, such as discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, feeling of something in the eye, increased sensitivity to light, or blurry vision, should seek timely medical care. At this time, CDC does not recommend testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.

More detailed information about the eye infections linked to EzriCare Artificial Tears is presented in this CDC Outbreak and Patient Notifications article, “Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears“. In that CDC document there is a “Current Update” part, from which we get the following three 

  1. As of January 31, 2023, CDC, in partnership with state and local health departments, identified 55 patients in 12 states (CA, CO, CT, FL, NJ, NM, NY, NV, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. Thirty-five patients were linked to four healthcare facility clusters. Dates of specimen collection were from May 2022 to January 2023.
  2. 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. This was the only common artificial tears product identified across the four healthcare facility clusters.
  3. Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing.

We will be monitoring the CDC as well as the FDA for further guidance, information, and warnings related to these serious eye infections linked to EzriCare Artificial Tears.


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