The Food and Drug Administration issued a warning in late October 2023 urging consumers to avoid purchasing and to immediately stop using 26 over-the-counter eye drop products because of risk of eye infection that could result in partial vision loss or even blindness. More products were soon added to the list, and a few others have been voluntarily recalled. No cases of eye infection from the products have been reported as of mid-November 2023. It’s just the latest in a series of warnings and recalls related to bacterial or fungal contamination of these products.
The Conversation spoke with assistant professor of infectious diseases Alexander Sundermann and Daria Van Tyne, an assistant professor of medicine – both from the University of Pittsburgh – to explain how such contamination can occur and what consumers can do to protect themselves.
The inspection found unsanitary conditions within the facility and detected “positive bacterial test results from environmental sampling of critical drug production areas.”
However, specific details about the type of bacteria, its source within the facility, the types of contamination found, the precise conditions leading to contamination or any infections associated with this alert have not been disclosed as of mid-November 2023.
This latest alert is similar to warnings about contaminated eye drops reported earlier this year that ultimately caused an outbreak of 81 infections and four deaths. Following the February outbreak, the FDA provided a comprehensive account of nonsterile conditions at a manufacturing facility in India that made the eye drop products sold in the U.S.
This new alert is defined as “contamination” in the processing area. Essentially, the FDA sampled the facility’s working environment and found bacterial growth where it should not be growing. The contamination does not yet mean there is an outbreak, defined as any infections caused from the contamination.
There could be infections associated with this new alert, but neither the FDA nor the Centers for Disease Control and Prevention has released any details as of mid-November 2023. During medication or device contamination or outbreaks, the CDC and the FDA work together to pinpoint the issues and prevent or control spread.
The February 2023 outbreak had both unsanitary conditions and contaminated eye drops – not just contamination in the environment – that also clearly caused infections and deaths. Essentially, this new alert could be a precursor to an outbreak that is cause for concern.
The Food and Drug Administration issued a warning in late October 2023 urging consumers to avoid purchasing and to immediately stop using 26 over-the-counter eye drop products because of risk of eye infection that could result in partial vision loss or even blindness. More products were soon added to the list, and a few others have been voluntarily recalled. No cases of eye infection from the products have been reported as of mid-November 2023. It’s just the latest in a series of warnings and recalls related to bacterial or fungal contamination of these products.
The Conversation spoke with assistant professor of infectious diseases Alexander Sundermann and Daria Van Tyne, an assistant professor of medicine – both from the University of Pittsburgh – to explain how such contamination can occur and what consumers can do to protect themselves.
The inspection found unsanitary conditions within the facility and detected “positive bacterial test results from environmental sampling of critical drug production areas.”
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