Recalled eye drops linked to bacteria linked to four deaths, CDC says

admin May 22, 2023

3 3 minutes read

Recalled eye drops linked to bacteria linked to four deaths, CDC says

Four people have now died in a multistate outbreak of a drug-resistant strain of bacteria linked to recalled eye drops, according to the Centers for Disease Control and Prevention.

The CDC and Food and Drug Administration warned patients and clinicians in February to stop using EzriCare or Delsam Pharma’s Artificial Tears products after one death from an infection and reactions in dozens of patients, some who experienced permanent eye loss.

The number of patients treated for a widely drug-resistant strain of Pseudomonas aeruginosa has now risen to 81[ads1] patients in 18 states — 13 more patients and two more states than in the agency’s last report, the CDC said in an update released Friday.

Seven of those patients had samples collected after the recall was announced, and they reported using the recalled artificial tears or living in a long-term care facility, causing health officials to worry about the potential person-to-person spread of infections. The other six cases had samples collected before the eye drop recall was announced. “These cases were confirmed after the recall date because of the time it takes for testing to confirm the outbreak strain and because of retrospective reporting of infections,” the CDC said in the report.

In addition to the four deaths, the outbreak investigation has confirmed 14 patients with vision loss and four cases of eyeballs that were surgically removed, the CDC said.

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Eye drops and ointment recalled in bacterial outbreaks

The products, EzriCare and Delsam Pharma’s Artificial Tears and Delsam Pharma Artificial Ointment, which were manufactured by India-based Global Pharma Healthcare, were recalled in February due to potential bacterial contamination – linked to the multi-status outbreak of a widely drug-resistant strain of Pseudomonas aeruginosa.

EzriCare was the brand of eye drops used by most patients and was the only product identified in the four health care facilities where cases have occurred, the CDC says. The CDC found the strain of bacteria in opened EzriCare bottles collected from patients, and the FDA found contamination in unopened bottles, the agencies say.

An FDA inspection conducted after the recall found that Global Pharma’s manufacturing process was unsterile: dirty equipment, faulty and ignored safety protocols, and workers wearing unsterile gowns.

The CDC and FDA have advised patients and clinicians to stop using and discard the products. Consumers with eye drops that are not under recall should feel safe continuing to use their products, health professionals say.

Officials are recommending nursing homes, long-term care and other healthcare facilities to practice infection control procedures to prevent further spread from person to person.

Where have patients reported eye infections during the outbreak in the United States?

The 18 states where cases have been confirmed by state and local health departments are California, Colorado, Connecticut, Delaware, Florida, Illinois, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin, according to the CDC.

What is Pseudomonas aeruginosa?

There are several types of Pseudomonas, a bacterium that can be found in the environment, including water and soil. Pseudomonas aeruginosa causes the most infections in humans, according to the CDC.

This strain is very rare and “had never been reported in the United States prior to this outbreak,” the CDC says.

Pseudomonas aeruginosa can spread to humans through contaminated surfaces, equipment, water and more. The bacteria can cause infections in the lungs, blood and other parts of the body.

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