[Image courtesy of ezricare-info.com]
Global Pharma Healthcare is voluntarily recalling lubricant eye drops owing to potential contamination. The recall is a result of an investigation by the Centers for Disease Control and Prevention (CDC) into a cluster of multi-state infections linked to the use of the product.
CDC suspects that a cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections are linked to the company’s eye drops.
An FDA notice states that the eye drops may cause serious adverse events, including eye infections, loss of vision and even death.
55 reports of adverse advents
There have been 55 reports of adverse events associated with the eye drops, including eye infections, permanent vision loss and a death associated with a bloodstream infection from May to December 2022.
A number of law firms, including Simmons Hanly Conroy, plan to sue Chennai, India–headquartered Global Pharma Healthcare over the issue.
EzriCare LLC and Delsam Pharma distribute the eye drops in question.
EzriCare has released a statement noting that it first learned of the CDC’s ongoing investigation into a multi-state cluster of Pseudomonas aeruginosa infections on January 20, 2023. The company stated on February 2 that it was “not aware of any testing that definitively links the Pseudomonas aeruginosa outbreak to EzriCare Artificial Tears.”
The company also stressed that it is prepared to cooperate with both CDC and FDA.
EzriCare also highlighted that it was not involved in manufacturing the product, noting that it had “no role in the formulation, packaging delivery system design or actual manufacturing of this product.”
Antibiotic resistance
The bacterial strains associated with the eye drops are resistant to various antibiotics. CDC notes that the isolates it tested were resistant to the antibiotics carbapenem, ceftazidime and cefepime. In addition, the agency found that the subset of isolates tested for susceptibility to ceftazidime-avibactam and ceftolozane-tazobactam were also resistant.
Antibiotic resistance is a growing public health crisis related to the overuse of antibiotics in human medicine, veterinary medicine and agriculture. The issue is making many common infections more difficult to treat, and some infections are now considered untreatable with currently available antibiotics. The problem can lead to extended hospital stays, higher healthcare costs and an increased risk of death.