Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are recommending healthcare providers and patients stop using EzriCare or Delsam Pharma’s Artificial Tears products.
The warning comes after a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa, called VIM-GES-CRPA, a combination not previously seen in the United States.
To date, there have been a total of 81 patients in 18 states that have been associated with this outbreak including California, Colorado, Connecticut, Delaware, Florida, Illinois, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington, and Wisconsin.
Patients have reported experiencing a variety of symptoms including eye infections, permanent vision loss, keratitis, endophthalmitis, respiratory infection, urinary tract infection, and sepsis. According to the CDC update, there have been 14 patients with vision loss, 4 patients required surgical removal of the affected eyeball, and 4 deaths.
EZRICARE AND DELSAM
The CDC release stated that a majority of patients reported using artificial tears and more than 10 different brands of artificial tears were identified with some patients using multiple brands.
However, one brand, EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the most commonly reported and was the only common artificial tears product found to be used across the four healthcare facility clusters. The eye drops are manufactured by the India-based company Global Pharma Healthcare Private Limited and sold under the names EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears.
The presence of VIM-GES-CRPA was found through CDC laboratory testing in opened EzriCare bottles from multiple lots and matched the outbreak strain. The bottles were collected from patients with and without eye infections from two different states. The FDA also tested unopened bottles of EzriCare Artificial Tears, finding bacterial contamination.
In February, the FDA issued a warning about EzriCare Artificial Tears due to contamination risks that could cause serious injury leading to vision problems or blindness and were linked to infections in 55 people, 5 cases of blindness, and 1 death.
LACK OF TESTING AND PROPER CONTROLS
The FDA recommended the recall based on manufacturing problems including lack of testing and proper controls on packaging. The agency also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with Current Good Manufacturing Practices (CGMP) regulations, which prevents these products from entering the United States.
WHAT TO DO IF INFECTED
The FDA and Global Pharma Healthcare Private Limited are advising that wholesalers, retailers, and customers who have the recalled product should stop use immediately.
It is recommended that consumers contact their physician or healthcare provider if they have experienced any problems that may be related to using any of these eyedrops and adverse reactions or quality problems may be reported to the FDA’s MedWatch Adverse Event Reporting program.
The CDC is also asking providers to report any P. aeruginosa specimens collected since January 1, 2022, to the local or state health department’s contact for healthcare-associated infections and to ask clinical laboratories to save these cultures for further identification at public health laboratories.
Treatment of this strain of P. aeruginosa is very difficult because it is resistant to multiple antibiotics. However, the CDC was able to find 3 possible options that could be used to treat this bacterial infection. Although the agency recommends that healthcare providers caring for patients with VIM-GES-CRPA infections should consult with a specialist who is knowledgeable in the treatment of antibiotic-resistant bacteria to determine the best course of treatment. Providers should also follow infection control recommendations to prevent transmission to other patients in healthcare settings.