According to a news report on CBSNews.com, the U.S. Food and Drug Administration reported that it has decided to restrict all product imports manufactured by Global Pharma Healthcare Private Limited. Global Pharma Healthcare Private Limited is an Indian healthcare company that manufactured eye drops connected to an outbreak of “extensively drug-resistant” bacteria throughout the United States. The FDA stated that it had demanded Global Pharma Healthcare Private Limited to recall its bacteria-contaminated eye drops. Global Pharma Healthcare Private Limited manufactured “artificial tears” that are marketed under the brand names Delsam Pharma and EzriCare.
The U.S. FDA cited several manufacturing regulation violations, including a “lack of proper controls concerning tamper-evident packaging” and a “lack of appropriate microbial testing.” As a result, the FDA issued a national alert warning consumers and health care providers to stop purchasing the artificial eye drop products and to immediately stop using Delsam Pharma’s Artificial Tears or EzriCare Artificial Tears due to probable bacterial contamination. According to an FDA statement, using bacteria-contaminated artificial tears increases the risk of eye infections which have led to cases of blindness and death.
The U.S. Centers for Disease Control and Prevention also issued a health alert to physicians in the U.S. over an unparalleled outbreak of Pseudomonas aeruginosa. At least 55 people across twelve U.S. states have become ill due to the Pseudomonas aeruginosa bacteria. The Pseudomonas aeruginosa strain behind the outbreak is known as Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant (VIM-GES-CRPA) and Verona Integron-mediated Metallo-β-lactamase (VIM). The strain is so rare that neither governmental agency has seen the bacteria before in the United States. However, testing of opened EzriCare eye drops bottles from patients living in two different states contained bacteria that matches the rare, outbreak strain.
The CDC stated that it was testing unopened bottles to determine if the VIM-GES-CRPA bacterial contamination was caused during the use or during the manufacturing of the products.
Unfortunately, at least one person was tragically killed due to a systemic bacterial infection. Five patients have permanently lost their vision due to bacterial infections in their eyes. The bacteria in the outbreak have also caused respiratory and urinary tract infections. Only one antibiotic, cefiderocol, seems to treat the strain.
The CDC is warning patients to seek immediate medical care if they have used EzriCare preservative-free artificial tears and have symptoms of an eye infection. Eye infection symptoms can include discomfort or pain in the eye, discharge coming out of the eye, eye redness, blurry vision, and increased sensitivity to light.
According to the CDC, EzriCare is the only brand that has been identified in all “four healthcare facility clusters” of eye infection cases. Martha Sharan, a spokesperson for the CDC, states that affected eye drops were sold at pharmacies, Amazon, and Walmart nationwide. Some patients also received artificial tears eye drops during inpatient or outpatient care visits.
According to the FDA, Global Pharma is now on the agency’s “red list” of banned imports because the company gave “an inadequate response” to the FDA’s records request and it failed to comply with federal manufacturing requirements. The FDA also faulted Global Pharma for manufacturing its eye drop products in multiple-use bottles without preservatives. This can make it much easier for bacteria inside the bottle prior to subsequent uses.
Global Pharma issued a statement saying that the company was “fully cooperating” with the FDA to investigate the problem. Global Pharma also stated that they did not believe their manufacturing facility was the source of the bacterial contamination but nonetheless issued the recall.
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