The U.S. Centers for Disease Control recently issued an update on the bacteria outbreak associated with eye drops it has been tracking for months.
The agency, in coordination with the U.S. Food and Drug Administration, has confirmed 81 Pseudomonas aeruginosa infections and four deaths across 18 states. Other adverse outcomes include 14 patients with vision loss and four that required an eyeball to be surgically removed. Sample collecting began in May 2022.
In most cases, patients reported using artificial tears prior to infection. More than 10 different brands of artificial tears eye drops have been cited. However, the on-going investigation into the multi-state outbreak has identified EzriCare Artificial Tears as the only common product associated with four healthcare facility clusters. Outbreaks in these four facilities account for about half of all cases reported to date.
Global Pharma Healthcare, the Indian manufacturer of the over-the-counter eyecare product, issued a voluntary recall of EziCare Artificial Tears and Delsam Pharma’s Artificial Tears on Feb. 2. The company then issued a recall of Delsam Pharma Artificial Eye Ointment on Feb. 22. The CDC first issued a health alert regarding the bacteria and its connection with the Global Pharma products on Feb. 1.
The CDC urges “patients and healthcare providers (to) immediately stop using and discard EzriCare Artificial Tears, Delsam Pharma Artificial Tears, and Delsam Pharma Artificial Ointment.”
According to the FDA, “Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.”
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Prior to the current outbreak, Pseudomonas aeruginosa had never been reported in the U.S.
Health care professionals are encouraged to immediately report any adverse reactions to these products – or any medications for that matter – to the FDA’s MedWatch Adverse Event Reporting Program. Consumers are directed to do the same by contacting the FDA’s Consumer Complaint Coordinators.
Eye infection symptoms may include:
- Yellow, green, or clear discharge from the eye
- Eye pain or discomfort
- Redness of the eye or eyelid
- Feeling of something in your eye (foreign body sensation)
- Increased sensitivity to light
- Blurry vision
As of the latest update, neither the CDC or FDA are recommending testing on patients who have yet to experience signs of infection.
Infections have been confirmed in these 18 states: California, Colorado, Connecticut, Delaware, Florida, Illinois, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin.
