Eye Drops Caused Severe Health Issues Months Before Recall
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Ohio doctors linked a blinded woman’s loss of vision to a highly drug-resistant bacteria found to be in Ezricare Artificial Tears months before U.S. officials warned of the contamination and recalls.
Nancy Montz, 72, was hospitalized after her eye became severely infected and she lost vision, according to NBC News. Doctors treating Montz’s corneal ulcer in November discovered she was infected with Pseudomonas aeruginosa, a drug-resistant bacterium formerly unreported in the United States but couldn’t figure out how it happened.
“We thought that this was just some sort of freak accident,” Dr. Morgan Morelli, an infectious disease doctor at University Hospitals Cleveland Medical Center, told NBC News. “We had no idea that this case was going to be linked to a global manufacturing issue.”
The Centers for Disease Control and Prevention sounded the alarm in February, warning people to stop using EzriCare Artificial Tears and Delsam Pharma eye drops because of sterility concerns. Global Pharma Healthcare manufactured both products in India and Aru Pharma imported them, according to an EzriCare statement.
However, according to an email sent to Consumer Notice by Aru Pharma’s attorneys, “Aru Pharma had no role in the formulation or manufacture of the eyedrops, nor did it ‘distribute’ them.” The company simply facilitated the purchase of the eye drops between EzriCare and Global Pharma.
Ezricare and Delsam Pharma Artificial Tears Lawsuits
Consumers have been 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. Three people have died, four others lost an eye and eight have sustained permanent vision loss along with other side effects.
The bacterial contamination has affected nearly 70 patients in 16 states, the CDC reported in March. The CDC has since identified cases as far back as spring 2022, according to the American Society for Microbiology.
Doctors Unravel Eye-Illness Mystery
Montz’s case was published last week in the Antimicrobial Agents and Chemotherapy Journal. An interdisciplinary group of researchers and physicians describe the case in which doctors traced the infection back to contaminated eye drops.
Montz, who was not named in the journal but was named in NBC’s reporting, began using the OTC eye drops to treat dry eyes about two weeks before she was hospitalized. A week into using the products she noticed a change in her vision and the appearance of her eye, according to the journal.
She went to the emergency room for help where ophthalmologists cultured the infection, prescribed her antibiotics and sent her home. The condition worsened overnight and Montz found a yellow discharge on her pillow, according to the report. When she followed up with a specialist, doctors decided to hospitalize her.
Microbiologists and infectious disease experts at the hospital later uncovered that the P. aeruginosa strain had caused the infection.
Bacterium Found in Eye Drops
The question became: How did Montz contract the bacterium? She didn’t wear contacts and she hadn’t gone swimming in a lake, both of which are common ways eyes can get infected with dangerous bacteria.
What she had used was an over-the-counter eye drop: EzriCare artificial tears. Health officials tested the eye drops and found the same deadly strain of bacterium in Montz’s multiuse eye drop container.
Researchers connected the eye infection and the ulcer it caused, to the contaminated drops, according to an ASM press release. Months later, the CDC would announce the recall. More than half of the patients who used the eye drops and became sick were connected to four health care facility clusters across 16 states.
Multidrug-Resistant Bacteria Raises Concerns
Montz’s treatment was tricky as the P. aeruginosa bacteria is resistant to drugs, making it difficult to treat. Doctors medicated Montz with an IV of a powerful antibiotic and two topical antibiotics.
The injury has improved according to the ASM. It’s unclear, however, if she will ever regain her vision.
“The emergence of MDR [multidrug resistant] bacteria is one of the most concerning threats in modern medicine,” researchers wrote in the journal. “These have occurred with both health care-associated and community-acquired infections.”
Although the products have been recalled and pulled from shelves, Morelli worries there is still a risk to those who have it in their homes.
“People may still have it on their medicine cabinet shelves,” Morelli said, in the ASM press release. “We don’t always get this detailed of a history or ask someone to bring in over-the-counter medicine they’re using. We really wanted to raise awareness.”
Consumers who have an adverse reaction or experience quality issues with the use of any of the recalled products may report it to the U.S. Food and Drug Administration’s MedWatch adverse event reporting program. Consumers can submit reports online, via regular mail or via fax.