PRO/EDR> Pseudomonas aeruginosa – USA (06): ex India/XDR/contam eye drops, more cases, RFI


A ProMED-mail post
ProMED-mail is a program of the
International Society for Infectious Diseases

[1] Date: Fri 19 May 2023 13:01 EDT
Source: CBS News [edited]

The outbreak of extensively drug-resistant bacteria linked to eye
drops recalled earlier this year [2023] is continuing to grow, the
Centers for Disease Control and Prevention (CDC) says, with 81 cases
and 4 deaths now reported across 18 states.

The figures published Friday [19 May 2023] by the agency mark the 1st
increase in deaths since March [2023], when the CDC tallied 3 dead. An
additional 13 more patients have also since been confirmed, although
around half of them were actually from specimens gathered before the
February [2023] recall of eye drops. “These cases were confirmed after
the recall date due to the time it takes for testing to confirm the
outbreak strain and because of retrospective reporting of infections,”
the CDC said.

For months, the Food and Drug Administration (FDA) has urged Americans
to stop using 2 brands of eye drops suspected by investigators to be
linked to the outbreak: Delsam Pharma and EzriCare. EzriCare
Artificial Tears eye drops are among the products being recalled.

An FDA inspection of the plant in India that had manufactured the
products, operated by Global Pharma Healthcare Private Limited, turned
up a range of issues, from dirty equipment to missing safeguards,
earlier this year [2023].

Testing done on already-opened bottles of EzriCare eye drops turned up
the same strain of bacteria driving the outbreak across multiple
states. In analyzing unopened tubes of a different product from the
same company, Delsam Pharma’s eye ointment, the FDA said earlier this
year [2023] they had found them to be contaminated with bacteria.

Now the FDA has found bacterial contamination in unopened bottles of
EzriCare as well, the CDC says. It is unclear what bacteria the FDA
found in the unopened bottles. A spokesperson for the regulator did
not immediately respond to a request for comment.

Of new cases that have been identified after the recall, the CDC says
most were either using brands that had been recalled or involved
people living in nursing homes with other previously diagnosed
infections. Health authorities have warned that the rare strain of
bacteria driving the outbreak — a specific variant of Pseudomonas
— was spreading person to person, especially through
contaminated surfaces in hospitals and other healthcare settings with
vulnerable patients.

“We usually find these strains in patients in healthcare settings, and
they’re spreading patient to patient through healthcare workers who
maybe forgot to wash their hands, through contaminated medical
equipment, or contamination in the healthcare environment,” the CDC’s
Mayora Walters told the “One Health Trust” podcast recently.

While Pseudomonas aeruginosa infections in general are common,
Walters said the outbreak’s rare drug-resistant strain — never before
seen in the United States — and its spread across facilities in
multiple states made the situation unusual. “At first we had 3
separate outbreaks in different types of healthcare facilities,
including very different types of healthcare facilities, and an
outpatient eye clinic,” said Walters.

A total of 14 people infected in the outbreak have now lost their
vision, up from 8 previously reported by the CDC. In addition, 4
patients needed their eyeballs surgically removed.

“Those just seemed to be sort of fairly typical outbreaks of this
organism, with the exception of the eye clinic, which was definitely
atypical because we’d actually never seen eye infections with this
organism before,” she said.

[Byline: Alexander Tin]

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