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The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have issued a warning urging healthcare providers and patients to discontinue the use of EzriCare or Delsam Pharma's Artificial Tears products. This cautionary measure follows a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa, identified as VIM-GES-CRPA, which has not been previously seen in the United States.
The outbreak has affected a total of 81 patients across 18 states, including California, Colorado, Connecticut, Delaware, Florida, Illinois, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington, and Wisconsin. Affected individuals have reported various symptoms, such as eye infections, permanent vision loss, keratitis, endophthalmitis, respiratory infection, urinary tract infection, and sepsis. The CDC update revealed that 14 patients experienced vision loss, 4 required surgical removal of the affected eyeball, and 4 deaths were reported.
While numerous brands of artificial tears were identified among the patients, EzriCare Artificial Tears emerged as the most commonly reported brand. This preservative-free, over-the-counter product, packaged in multidose bottles, was found to be used by patients in all four healthcare facility clusters. Manufactured by Global Pharma Healthcare Private Limited, an India-based company, EzriCare Artificial Tears is also sold under the name Delsam Pharma's Artificial Tears.
CDC laboratory testing confirmed the presence of the VIM-GES-CRPA strain in opened EzriCare bottles from multiple lots, which matched the outbreak strain. The bottles were collected from patients both with and without eye infections in different states. The FDA's testing of unopened bottles of EzriCare Artificial Tears also revealed bacterial contamination.
Earlier in February, the FDA had already issued a warning about EzriCare Artificial Tears due to contamination risks. This warning was associated with infections in 55 individuals, including 5 cases of blindness and 1 death. The FDA cited manufacturing problems, including inadequate testing and insufficient controls on packaging, as the reason for recommending a recall of the product. Furthermore, Global Pharma Healthcare Private Limited was placed on import alert by the FDA for providing an unsatisfactory response to records requests and for non-compliance with Current Good Manufacturing Practices (CGMP) regulations, which prevent such products from entering the United States.
In light of the recent developments, both the FDA and Global Pharma Healthcare Private Limited are advising wholesalers, retailers, and customers in possession of the recalled product to cease its use immediately. Individuals who have used these eye drops and experienced any related problems are encouraged to contact their physician or healthcare provider. Adverse reactions or quality issues can be reported to the FDA through its MedWatch Adverse Event Reporting program.
The Importance of Safety Regulations:
The investigation serves as a poignant reminder of the critical need for comprehensive safety regulations when it comes to infant products. Padded baby loungers, which are commonly used by parents, should undergo rigorous testing and adhere to strict safety standards to prevent further tragedies. The rejection of proposed regulations in 2015 highlights the potential consequences of inadequate safety measures and the importance of prioritizing the well-being of infants.
Moving Forward:
In light of the investigation's findings, it is crucial for the CPSC to reevaluate its approach to infant product safety. Stricter regulations, thorough testing procedures, and effective communication about potential risks are necessary to protect vulnerable infants and their families. Learning from past mistakes, the CPSC should prioritize collaboration, research, and timely action to ensure that all baby products meet the highest safety standards.