The U.S. Centers for Disease Control and Prevention (CDC) reported a fourth death resulting from a drug-resistant bacterial infection linked to recalled eye drop. Four others have had to have an eye surgically removed.
As of May 15, an additional 13 cases had been infected with a rare strain of a highly drug-resistant bacteria, the CDC reported in an update.
This brings the total number of cases to 81 from across 18 states. So far, four people have died, 14 patients have lost eyesight in one eye, and four needed to have an eyeball surgically removed.
The specific bacteria, a rare strain of Pseudomonas aeruginosa, has never been seen in the United States before this outbreak, which is linked to the EzriCare Artificial Tears Lubricant Eye Drops.
The CDC has also recommended discarding two other products made by the same manufacturer: Delsam Pharma’s Artificial Tears, and Delsam Pharma Artificial Ointment.
“The bacteria can spread when one patient carrying the bacteria exposes another patient, or when patients touch common items or when healthcare workers transmit the germs which is why infection control, like hand hygiene, is so important,” the CDC told CNN.
The products were recalled by their Indian manufacturer Global Pharma Healthcare Private Limited in early February upon FDA recommendations. Both the CDC and U.S. Food and Drug Administration (FDA) have since warned consumers not to use the products.
Among the 13 new patients, six had bought the product before its recall date, while the other seven reported using the eye drops after their recall date.
According to the FDA, Global Pharma already had several Current Good Manufacturing Practice (CGMP) regulation violations. These include lack of appropriate microbial testing, formulation issues such as reusing bottles without adequate preservatives, and lack of proper controls concerning tamper-evident packaging.
The FDA placed Global Pharma on import alert over its previous CGMP violations and for “providing an inadequate response to a records request.” The import alert will prevent the products from entering the United States.
According to Global Pharma, it first received a CDC notice of an investigation on Jan. 20, but at the time, it had itself not yet received any consumer complaints.
The CDC investigation revealed that afflicted patients reported using 10 different brands of artificial tears, as some used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the only brand identified consistently across four health care facility clusters.
Laboratory testing by CDC identified the presence of the specific strain of Pseudomonas aeruginosa in opened EzriCare bottles collected from patients with and without eye infections in two states.
Testing of unopened bottles of EzriCare Artificial Tears by the FDA also found bacterial contamination; the precise determination of the contaminants is ongoing.
Adverse reactions experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program.