Eyedrops Recall: 4th Death Linked to Outbreak

UPDATE May 22, 2023 11:05 AM CDT

A fourth death has been linked to an outbreak of drug-resistant bacteria blamed on eyedrops, reports USA Today. The CDC now counts 81 patients in 18 states affected by the outbreak, which prompted the recall of EzriCare artificial tears, made by Global Pharma Healthcare. The CDC also warns people to stop using two additional products from the same manufacturer, Delsam Pharma's Artificial Tears and Delsam Pharma's Artificial Ointment. In addition to the deaths, at least 14 people have suffered vision loss.

Apr 3, 2023 10:53 AM CDT

Eyedrops tainted with a highly drug-resistant bacteria have now been linked to three deaths in the US, prodding FDA inspectors to visit the India-based manufacturer of EzriCare artificial tears. CBS News cites government records that show dozens of problems were flagged during the Feb. 20 to March 2 inspection of Global Pharma Healthcare, including a "black, brown greasy deposit" on a bottle-filling machine, surfaces that weren't sterilized, ingredient verification checks that weren't conducted, and "discolored, worn-out" protective booties. More:

• What's the source of the bacteria? It remains a little murky, per CBS. Initially, the bacteria was only found in opened bottles of Global Pharma's drops, and testing on still-sealed bottles came back negative. But the FDA later extended the warning from EzriCare to a second eye product manufactured by Global Pharma, Delsam Pharma's Artificial Eye Ointment. The FDA said it "found unopened tubes to be contaminated with bacteria," though it didn't name the bacteria.
• More on the impact: The multistate outbreak has left another eight people blind and caused four to lose an eyeball, per the CDC, and all of the company's eyedrops have been recalled. The strain behind the outbreak, an extremely drug-resistant Pseudomonas aeruginosa, has never been reported in the US.
• The trouble with overseas manufacturers: The New York Times reports the FDA confirmed its February visit to the plant was its first. The paper explains the FDA doesn't require a preapproval inspection of plants that make OTC medicines, and the FDA conducted just 684 overseas inspections in 2022; it has some 4,000 foreign facilities to inspect, and about 1 in 5 are in India.

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• The trouble with EzriCare: There are no preservatives in the drops, which Dr. Vicente Diaz, the chief of ophthalmology at Yale Health Plan, tells the NYT is bizarre. Typically preservative-free options are limited to single-use drops to mitigate risk. "I'm surprised that formulation was allowed to go on the market without more scrutiny," he said.
• NYT raises the alarm: It reports the bacteria has spread between residents of one Connecticut long-term care center, with the bacteria detected in asymptomatic patients. That raises concerns "that the strain could gain a foothold in US health care settings," with one infectious disease specialist saying it's tough to rid facilities of resistant Pseudomonas because "it clings tenaciously to sink drains, water faucets, and other moist environments." Indeed, the AP reports the bacteria is commonly linked to outbreaks in hospitals in India.
• Those affected: CNN has stories of some of the 68 people who've been diagnosed with infections from the bacteria, including Carla Oliva, 68. The Florida woman used EzriCare artificial tears for dry eyes for two months before experiencing burning and itchiness in her right eye. As her symptoms worsened, doctors identified a large ulcer tied to Pseudomonas. After a month spent receiving daily topical antibiotics that increased in strength, doctors determined the eye had to be removed.

(More drug-resistant bacteria stories.)