CDC Identifies More Deaths Linked to Drug-Resistant Bacteria in Recalled Product

A petri dish culture shows a bacterial culture as seen in a file photo. CDC/Melissa Dankel

The U.S. Centers for Disease Control and Prevention (CDC) identified two additional deaths in connection to a rare strain of bacteria associated with recalled eye drops, according to a recent update.

In a March 21 update, the federal health agency said that three people so far have died, eight people have lost their vision, and a total of 68 people in 16 states have contracted the antibiotic-resistant bacteria, Pseudomonas aeruginosa. Some 37 patients have been linked to four healthcare centers, it noted.

“Most patients reported using artificial tears,” the CDC update said. “Patients reported over 10 different brands of artificial tears and some patients used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported.”

Several weeks ago, Global Pharma Healthcare announced the recall of its Artificial Tears Lubricant Eye Drops that were distributed by EzriCare and Delsam Pharma. Both the CDC and U.S. Food and Drug Administration (FDA) have warned consumers not to use the products.

A case report published in the JAMA Ophthalmology journal on Wednesday provided more insight into how the bacteria-linked cases developed. It noted that a 72-year-old woman lost vision in one of her eyes after using EzriCare’s products for several days.

The 72-year-old woman “presented with vision loss in the left eye for 1 week,” the report said, noting that she reported use of over-the-counter eye drops for dry eye syndrome. A bacterial “culture of left corneal scrapings grew extensively drug-resistant Pseudomonas aeruginosa, susceptible only to cefiderocol,” the case report said, referring to a powerful antibiotic.

A culture of her EzriCare artificial tears “grew comparable drug-resistant P aeruginosa,” it said. “She was treated with intravenous cefiderocol, topical imipenem/cilistatin, and topical polymyxin B/trimethroprim. Her course was complicated by a serous choroidal detachment detected by B-scan ultrasonography.”

A separate case, published in JAMA, involved a 72-year-old man who developed a drug-resistant Pseudomonas aeruginosa infection of the cornea after he, too, used EzriCare artificial tears. A doctor who treated him told CNN that he had a serious corneal infection and was given strong antibiotics.

“We typically expect some degree of improvement [with] these medications, but when we saw him two day later, he was getting far worse,” Dr. Naomi Gutkind, a resident physician who also treated him, said. “So that’s when we inquired about specifically the EzriCare tears, because we knew they were associated with resistant infection that may not respond to those really strong antibiotics.”

Another doctor said that the man, after two months, still had serious eye impairment. In a follow-up appointment, he had 20/400 vision, medical officials told CNN.

“At some point, he was in danger of having permanent vision loss,” Dr. Guillermo Amescua, an ophthalmologist at Bascom Palmer Eye Institute, told the network. “He now has what is called corneal blindness because he’s 20/400 and has a corneal scar, but with corneal transplantation, he might have a better prognosis.”

Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by EzriCare, LLC and Delsam Pharma, due to possible contamination, Feb. 1, 2023. Courtesy of the Global Pharma

Symptoms of a Pseudomonas aeruginosa can vary greatly depending on the location of the infection. If the infection is the lungs it could cause pneumonia, if it is in a wound, there might be blue-green pus in the area, for example. The bacteria, when it infects the inner or middle ear, can also cause an earache.

“When the infections are elsewhere in the body, you may have a fever and feel tired,” says a government health website. “But all pseudomonas infections can make you very sick if they spread through the bloodstream (septicemia). A serious infection can cause symptoms of high fever, chills, confusion, and shock.”

EzriCare Response

In a statement earlier this year, EzriCare said that it hasn’t seen testing linking its eye drops to the antibiotic-resistant bacteria. However, the company confirmed that it will discontinue distributing the eye drops.

“As of today, we are not aware of any testing that definitively links the Pseudomonas aeruginosa outbreak to EzriCare Artificial Tears. 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 said on its website.

According to the company, it first received a CDC notice of an investigation on Jan. 20 and at the time, did not receive any consumer complaints of an adverse report linked to its products. Its last update was issued on Feb. 2 when it announced a recall.

“To the greatest extent possible, we have been contacting customers to advise them against continued use of the product. We also immediately reached out to both CDC and FDA and indicated our willingness to cooperate with any requests they may have of us,” stated EzriCare. The eye drops in question, it said, were manufactured in India by Global Pharma Healthcare PVT Limited and imported into the United States by Aru Pharma Inc.