March 27, 2023 Source: drugdu 144
Renee Martray of South Carolina has severe and permanent corneal scarring resulting in vision loss. She says it’s like trying to peer through eyeglasses that have been dipped in oil.
Nancy Montz of Ohio developed a corneal ulcer, spent three weeks in the hospital and lost vision in her left eye.
Carla Oliva of Florida developed a severe eye infection and, when treatment failed, had to have her right eye removed. She’s now legally blind.
The women said their problems began after they used EzriCare Artificial Tears, which is part of a US Centers for Disease Control and Prevention and US Food and Drug Administration investigation into a multistate outbreak of a rare strain of bacteria.
EzriCare said in a statement last month that when it learned of the investigation January 20, it was not aware of any testing that definitively linked the outbreak to its product.
“Nonetheless, we immediately took action to stop any further distribution or sale of EzriCare Artificial Tears. To the greatest extent possible, we have been contacting customers to advise them against continued use of the product.”
EzriCare did not respond to CNN’s request for comment this week. The artificial tears are made by India-based Global Pharma Healthcare, which issued a recall of both EzriCare and Delsam Pharma artificial tears.
Delsam Pharma’s product has not been linked to infections, but the CDC and US Food and Drug Administration have advised patients to stop using eye drops from either company pending additional guidance.
Since the start of its investigation, the CDC has identified 68 people in 16 states with infections of a rare strain of multidrug-resistant Pseudomonas aeruginosa that had never before been reported in the United States.
There have been three deaths, eight cases of vision loss and four surgical eye removals reported, according to the CDC.
The investigation started with three distinct outbreaks and no apparent connection, said Dr. Maroya Walters, public health service officer and the CDC’s lead investigator on the outbreak.
The agency was initially notified in late June 2022 about eye infections among four people at an ophthalmology clinic in California, and tests revealed the unexpected bacteria behind them, Walters said.
The bacteria had a mutation that makes it highly resistant to drugs designed to treat it. This type of drug-resistant Pseudomonas had never been associated with an eye infection, Walters said.
Walters told CNN two other infection outbreaks were reported at long-term care facilities. One involved 21 people in Connecticut in late July and another included three people in Utah in August.
Genetic sequencing in September revealed that the three bacterial strains were nearly identical, Walters said.
“The patients had very, very few overarching commonalities. They were from different kinds of facilities that had different kinds of infections,” Walters said. “We were really looking comprehensively at products that patients received but not finding a lot of commonalities.”
‘What did I do?’
As the investigators were searching for a common source, eye drop users searched for answers.
Oliva, 68, says she was given EzriCare artificial tears for dry eyes from a medical center in Hialeah, Florida, in May. After using the drops for two months, she woke up August 1 with burning, itchiness, redness and tearing in her right eye.
She went to an ophthalmologist, who said she had a corneal scratch and prescribed antibiotics, but her symptoms just got worse. She then went to Bascom Palmer Eye Institute, where physicians discovered a large ulcer associated with Pseudomonas aeruginosa.
Oliva says she went to Bascom Palmer every day from August 4 to September 1 to receive topical antibiotics. They also tried stronger and stronger medications, but the infection persisted.
Doctors attempted to do a cornea transplant August 29, but the infection was too severe to save the eye. It was surgically removed September 1 and replaced with a plastic implant at the end of December.
She spent months wondering what happened.
“I cried constantly, asking why this happened to me. How could this have happened to me? I was searching for an answer: What happened to me? At what moment? How? When? What did I do?” she told CNN in Spanish. “And to not have an answer, that is the most terrible thing.”
But because she didn’t know about the investigation until after she lost her eye, she continued to use the drops.
Martray, 48, also had dry eyes and bought the artificial tears at a store in South Carolina last summer. After using them for about a month, she began having pain, swelling, burning, blurry vision, watering and redness.
She went to an eye doctor and got antibiotics to try to treat the infection. But she continued to use the drops until October.
In December, the infection returned. She says she went to the clinic every day, including Christmas Eve and Christmas Day. She was eventually diagnosed with severe, permanent corneal scarring.
She says her condition left her “very depressed.”
“When it first came about, I just didn’t even want to leave the house. I just laid around and cried. I just wanted to get better,” she said.
Detecting future outbreaks
Similar cases were being reported across the country. According to a statement released January 20 from the CDC, from May 17 to January 19, the agency, in partnership with state and local health departments, identified the bacteria in 50 people across 11 states, with 38 cases linked to four health care facility outbreaks.
Most of the people reported using artificial tears, the CDC said, and EzriCare Artificial Tears was the brand most commonly reported.
The agency’s lab testing confirmed the presence of the outbreak strain in opened eye drop bottles. Researchers are now testing unopened bottles for the same bacteria.
Walters attributes the discovery in large part to sequencing and reporting done at state and local health departments.
“I think without that, we never would have found this outbreak, and we need to really keep those programs strong, because I’m sure this is not the last time,” she said. “We need to maintain these activities to be able to detect future outbreaks and to be even faster at detecting them and finding the source.”
Walters says the CDC continues to receive reports of “catastrophic and life-altering infections,” many of them months old.
‘I feel useless’
Oliva said she learned about the eye drop recall on the news early this year. At first, she felt relieved.
“On the other hand, I felt anger and indignation, because how could they be so negligent, so careless to make a product that could cost someone’s life?” said Oliva, who has filed a lawsuit against several companies including EzriCare and Global Pharma.
She says she’s had to learn how to walk again due to new issues with stability. She has trouble driving, working or doing everyday tasks like going to the grocery store.
“Everything has changed. I feel useless.”
Martray, who has also filed a lawsuit against several companies including EzriCare and Global Pharma, said she learned about the bacteria from news articles her daughter sent her.
“I’m really shocked, because I’ve always just – I just trusted,” she said. “I feel that if they’re made for the eyes and the box is sealed and everything, it’s good. I never thought that something like that could happen. They were sealed bottle drops. You just grab them, you put them in your eyes, you don’t even think twice about it. Especially when you’ve been wearing contacts since sixth grade.”
EzriCare and Global Pharma did not respond to requests for comment on the lawsuits or the ongoing investigation. CNN initially reached out to EzriCare on March 17.
Learning to adjust
Montz, 72, had used EzriCare tears for about a week in November when she started noticing blurry vision. One morning, she woke to find yellow discharge on her pillow. She went to the emergency room, where doctors discovered a large ulcer on her left cornea, involving nearly the entire eye.
She spent three weeks in the hospital, where she got antibiotics and multiple surgeries. Her case was complicated by a serous choroidal detachment, an abnormal accumulation of fluid, which ultimately led to vision loss in the left eye.
She said she’s learning to accept her situation and feels “pretty good” despite weeks of treatment.
“It is what it is. Me being crabby is not going to change anything, I have to make the best of it, accept it and go on,” she said.
Martray says she’s been having frequent migraines from straining her eyes and can no longer do many things she previously enjoyed, like baking or crafts.
“You don’t realize how much you rely on your vision for, I mean, just everything. Your vision is everything,” she said.
Oliva wants accountability for what happened to her and others.
“I want those responsible for doing this to me and other people to pay for their negligence, because they were negligent. They marketed something that was contaminated,” she said. “They played with my life and my family’s life.”
Link: https://edition.cnn.com/2023/03/24/health/eye-infection-patients
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