Last year, Judith Gregory’s left eye started to exhibit symptoms of redness, excessive tearing, and pain. Her journey to address these complications began with a visit to her eye doctor, but over time, her condition worsened.
“At that time, I could still see out of my eye,” recalled Gregory. “But a week later, I couldn’t even see out of it.”
Hailing from Elsmere, Kentucky, the 81-year-old woman endured a series of medical appointments, surgeries, and an eight-day hospital stay, all stemming from an eye infection. She attributes the infection to tainted over-the-counter eye drops she had purchased both in a retail store and online.
Gregory has taken legal action against India-based Global Pharma Healthcare, alleging that their product, EzriCare Artificial Tears, was “contaminated with a dangerous and potentially life-threatening bacteria” that led to “financial and personal injury.”
In February, Global Pharma issued a recall for EzriCare and another eye drop brand, citing potential contamination with drug-resistant bacteria associated with infections resulting in deaths, eye removal surgeries, and blindness.
In another public health alert the following month, the U.S. Food and Drug Administration (FDA) cautioned consumers to avoid or dispose of more than two dozen varieties of eye drops. These over-the-counter products, sold by CVS Health, Rite Aid, Target, Walmart, Leader/Cardinal Health, Rugby/Harvard Drug Group, and Velocity Pharma LLC, were flagged for their potential to cause infections leading to vision loss or blindness.
This recall exposed an issue that had long gone unnoticed: over-the-counter eye drops, used by millions of Americans for various eye conditions, had not received the same level of scrutiny as prescription products. While doctors maintain that the majority of non-prescription eye drops available in chain stores are safe, a recent scientific paper has highlighted regulatory gaps that may have allowed a small number of contaminated products to reach consumers, posing serious risks.
In 2022, U.S. consumers spent nearly $1.6 billion on 149 million eye care products. Despite the widespread use of retail eye drops, the market remains “largely self-regulated, despite the potential for serious injury,” according to a viewpoint published in the Journal of the American Medical Association Ophthalmology.
Timothy Milton Janetos, an assistant professor of ophthalmology at Northwestern University and co-author of the JAMA Ophthalmology paper, emphasized that the vast majority of over-the-counter eye drops are safe. However, evaluating the less than 1% risk of contamination in these products poses a challenge for both doctors and consumers.
“It’s difficult for physicians because we are frequently asked, ‘What is safe for me?'” Milton explained. “I can’t make a recommendation because there’s no reliable source of information to determine if an eye drop is good or bad.”
Milton and co-author David N. Younessi concluded that “limitations in regulatory oversight highlight a substantial gap in the public health safety net, potentially leaving consumers exposed to harmful products.”
Prescription drugs undergo rigorous safety and efficacy evaluations before receiving FDA approval. In contrast, over-the-counter drugs do not undergo a similar review before hitting store shelves.
Over-the-counter drug manufacturers must adhere to FDA requirements for ingredients, uses, doses, labeling, testing, and administration instructions. However, since the FDA does not pre-approve these drugs for market release, it is the responsibility of drug manufacturers to follow these guidelines rather than the FDA enforcing them, as stated in the JAMA Ophthalmology paper.
Another potential reason for the circulation of contaminated eye drops, as cited in the paper, is the FDA’s suspension of most routine on-site inspections of overseas drug factories during the first two years of the COVID-19 pandemic. Although on-site inspections have resumed, they occur less frequently than before the pandemic.
The investigation into this issue has uncovered cases of blindness, deaths, and eye removal surgeries linked to contaminated eye drops. Global Pharma Healthcare manufactured three of the recalled brands: EzriCare Artificial Tears, Delsam Pharma Artificial Tears, and Delsam Pharma artificial ointment.
The FDA has faced longstanding scrutiny from Congress and oversight investigators regarding inspections of overseas drug factories. Prior to the COVID-19 pandemic, Congress raised concerns about drug safety following recalls of blood pressure drugs contaminated with carcinogens.
Before the pandemic, the FDA conducted more than 600 foreign inspections, with 18 “high priority” overseas inspections from October 2020 through April 2021, primarily in China, as reported by the U.S. Government Accountability Office in 2022.
Global Pharma’s factory in India had not been inspected by the FDA before the company issued a recall for the artificial tears on February 2nd, citing potential contamination. Subsequent FDA inspections, conducted from February 20th through March 2nd, revealed numerous safety concerns, including a lack of sterility protocols, airflow issues, and no sterility testing of bottle caps.
The investigation received support from the Centers for Disease Control and Prevention (CDC), which tracked 81 individuals infected with an antibiotic-resistant strain, Pseudomonas aeruginosa, as of May 15th. Among these cases, 14 individuals experienced blindness, four underwent eye removal surgeries, and four died.
Global Pharma publicly announced the contamination issue on February 2nd, but the CDC’s investigation suggested infections had occurred months earlier, with cases dating back to May 2022.
The CDC’s investigation revealed that patients reported using ten different brands of artificial tears, with EzriCare being the only common product identified across four health sites reporting clusters of cases. Testing of open bottles of EzriCare retrieved from patients confirmed the presence of antibiotic-resistant bacteria.
Global Pharma, headquartered in Chennai, India, did not respond to multiple requests for comment.
Judith Gregory, the Kentucky resident who initiated legal action against Global Pharma, disclosed that she had purchased EzriCare tears from Walmart and Amazon. On June 1st, 2022, she reported eye pain, discharge, redness, and blurred vision to her eye doctor. The following day, she was admitted to an intensive care unit, where she remained for eight days while recovering from sepsis. Medical tests on her eye identified the strain of antibiotic-resistant bacteria “consistent with her use of the contaminated product,” as stated in the lawsuit.
In addition to Global Pharma, Gregory’s lawsuit names EzriCare LLC, Aru Pharma Inc., Amazon, and Walmart as defendants.
Regulatory gaps have slowed recalls and delayed the removal of potentially harmful products from the market. While the CDC has not reported additional cases related to the Global Pharma recall, two more eye drop recalls have been issued since that warning.
In August, the CDC cautioned against the use of two eye drop brands due to reports of bacterial contamination.
The most recent warning came on October 27th when the FDA advised people to avoid more than two dozen versions of eye drops due to the risk of infection leading to partial vision loss or blindness. These eye drops were available at major retailers such as CVS, Rite Aid, Target, and Walmart.
The FDA’s inspection at an undisclosed manufacturing site revealed unsanitary conditions and positive bacterial tests in drug production areas.
Two of the distributors involved in the recall, Harvard Drug Group and Cardinal Health, stated that they had received the recalled eye drops from a drug.