Two brands of eye drops have been contaminated with a dangerous drug-resistant bacteria that can cause severe disease, blindness and death, according to the U.S. Food and Drug Administration (FDA).
The FDA issued a consumer warning on Feb. 2 for two brands of eye drops – Delsam Pharma’s Artificial Tears and EzriCare Artificial Tears.
Both products are produced by Global Phara Healthcare, which initiated a voluntary recall on the dry eye solutions after an investigation by the Center for Disease Control and Prevention (CDC).
The CDC is collaborating with the FDA and state and local health departments to investigate a multistate outbreak of a strain of Pseudomonas aeruginosa.
The strain has never been reported in the U.S. before now and is extensively drug resistant.
As of Jan. 31, the CDC identified 55 patients in 12 states with these infections. As a result of the infections, one person has died of bloodstream infection and five patients have reported vision loss. Thirty-five of the cases are linked to four healthcare facility clusters.
Patient research and testing led the CDC to determine the cause of the infections to be the contaminated eye drops.
Global Phara Healthcare also currently has good manufacturing practice violations with the FDA for a lack of appropriate microbial testing, formulation issues and lack of proper controls concerning tamper-evident packaging.
Consumers and retailers are asked to immediately discontinue both brands of eye drops. Anyone that may have used the product should be cognizant of infection symptoms, which 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
Anyone experiencing symptoms should seek medical attention as soon as possible.
The FDA encourages healthcare professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program. Consumers may also report adverse reactions by contacting FDA’s Consumer Complaint Coordinators.