Contaminated Eye Drops Linked to 4th Death, More Injuries
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U.S. health officials have reported an additional death and six more cases of vision loss linked to infections caused by recalled EzriCare Artificial Tears and Delsym Pharma products.
In an update this week, the Centers for Disease Control and Prevention raised the death toll to four and reported a total of two dozen cases of vision loss and four cases of people who’ve had eyeballs removed.
There are now 81 patients in 18 states who have been impacted by a rare strain of drug-resistant Pseudomonas aeruginosa, a bacterium formerly not seen in the U.S. prior to the outbreak, according to the CDC. Patients reported using more than 10 different brands of eye drops, most commonly EzriCare Artificial Tears, the CDC said.
Contamination Concerns Prompt Recall
Global Pharma, an India-based manufacturer, issued a voluntary recall of EzriCare Artificial Tears in early February because of contamination issues.
“[The] CDC and FDA recommend clinicians and patients stop using and discard EzriCare Artificial Tears and two additional products made by the same manufacturer, Delsam Pharma’s Artificial Tears and Delsam Pharma’s Artificial Ointment,” the CDC said in a statement.
Investigators have uncovered cases dating as far back as May 2022. Seven patients who were identified after the recall either lived in a long-term care facility with other known cases or reported using a recalled brand of artificial tears, the CDC said.
Since the outbreak was reported, consumers have begun filing EzriCare Artificial Tears lawsuits against Global Pharma Healthcare, Aru Pharma, EzriCare and others after using the eye drops and developing Pseudomonas aeruginosa infections. Some plaintiffs underwent months of antibiotic treatment, had surgery or had the infection spread across their body.
Drug-Resistant Bacteria Strain Causes Serious Illness
Investigators have identified the outbreak strain as drug-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA). Laboratory testing found the strain of bacteria in opened, multiuse bottles of EzriCare Artificial Tears from multiple lots recovered from two states. The bottles were collected from patients with and without infections, according to the CDC.
“Testing of unopened bottles of EzriCare Artificial Tears by FDA identified bacterial contamination; further characterization of the contaminants is ongoing,” the CDC said.
Inspectors with the U.S. Food and Drug Administration visited Global Pharma’s manufacturing facility in India about two weeks after the recall and later released a lengthy report. The heavily redacted report noted 11 areas of concern at the site, including sterility and manufacturing protocols.
Since the recall, Global Pharma Healthcare has been placed under an FDA import alert, meaning no products made by this manufacturer are allowed into the U.S.
Symptoms of eye infection from contaminated eye drops include:
- Blurry vision
- Discharge from the eye that’s yellow, green or clear
- Eye or eyelid redness
- Eye pain or discomfort
- Feeling that there is something in the eye (foreign body sensation)
- Increased light sensitivity
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.